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Live Notes, Real Time Conference Coverage 2020 AACR Virtual Meeting April 28, 2020 Session on NCI Activities: COVID-19 and Cancer Research 5:20 PM

Reporter: Stephen J. Williams, PhD

NCI Activities: COVID-19 and Cancer Research

Dinah S. Singer. NCI-DCB, Bethesda, MD @theNCI

  • at the NCI they are pivoting some of their clinical trials to address COVID related issues like trials on tocilizumab and producing longitudinal cohorts of cancer patients and COVID for further analysis and studies
  • vaccine and antibody efforts at NCI and they are asking all their cancer centers (Cancer COVID Consortium) collecting data
  • Moonshot is collecting metadata but now COVID data from cellular therapy patients
  • they are about to publish new grants related to COVID and adding option to investigators to use current funds to do COVID related options
  • she says if at home take the time to think, write manuscripts, analyze data BE A REVIEWER FOR JOURNALS,
  • SSMMART project from Moonshot is still active
  • so far NCI and NIH grant process is ongoing although the peer review process is slower
  • they have extended deadlines with NO justification required (extend 90 days)
  • also allowing flexibility on use of grant money and allowing more early investigator rules and lax on those rules
  • non competitive renewals (type 5) will allow restructuring of project; contact program administrator
  • she and NCI heard rumors of institutions shutting down cancer research she is stressing to them not to do that
  • non refundable travel costs may be charged to the grant
  • NCI contemplating on extending the early investigator time
  • for more information go to NIH and NCI COVID-19 pages which have more guidances updated regularly

Follow on Twitter at:

@pharma_BI

@AACR

@CureCancerNow

@pharmanews

@BiotechWorld

@theNCI

#AACR20

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Responses to the #COVID-19 outbreak from Oncologists, Cancer Societies and the NCI: Important information for cancer patients

Curator: Stephen J. Williams, Ph.D.

UPDATED 3/20/2020

Among the people who are identified at risk of coronovirus 2019 infection and complications of the virus include cancer patients undergoing chemotherapy, who in general, can be immunosuppressed, especially while patients are undergoing their treatment.  This has created anxiety among many cancer patients as well as their care givers and prompted many oncologist professional groups, cancer societies, and cancer centers to formulate some sort of guidelines for both the cancer patients and the oncology professional with respect to limiting the risk of infection to coronavirus (COVID19). 

 

This information will be periodically updated and we are working to get a Live Twitter Feed to bring oncologist and cancer patient advocacy groups together so up to date information can be communicated rapidly.  Please see this page regularly for updates as new information is curated.

IN ADDITION, I will curate a listing of drugs with adverse events of immunosuppression for people who might wonder if the medications they are taking are raising their risk of infections.

Please also see @pharma_BI for updates as well.

Please also see our Coronavirus Portal at https://pharmaceuticalintelligence.com/coronavirus-portal/

For ease of reading information for patients are BOLDED and in RED

ASCO’s Response to COVID-19

From the Cancer Letter: The following is a guest editorial by American Society of Clinical Oncology (ASCO) Executive Vice President and Chief Medical Officer Richard L. Schilsky MD, FACP, FSCT, FASCO. This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.

 

The worldwide spread of the coronavirus (COVID-19) presents unprecedented challenges to the cancer care delivery system.

Our patients are already dealing with a life-threatening illness and are particularly vulnerable to this viral infection, which can be even more deadly for them. Further, as restrictions in daily movement and social distancing take hold, vulnerable patients may be disconnected from friends, family or other support they need as they manage their cancer.

As providers, we rely on evidence and experience when treating patients but now we face uncertainty. There are limited data to guide us in the specific management of cancer patients confronting COVID-19 and, at present, we have no population-level guidance regarding acceptable or appropriate adjustments of treatment and practice operations that both ensure the best outcome for our patients and protect the safety of our colleagues and staff.

As normal life is dramatically changed, we are all feeling anxious about the extreme economic challenges we face, but these issues are perhaps even more difficult for our patients, many of whom are now facing interruption

As we confront this extraordinary situation, the health and safety of members, staff, and individuals with cancer—in fact, the entire cancer community—is ASCO’s highest priority.

ASCO has been actively monitoring and responding to the pandemic to ensure that accurate information is readily available to clinicians and their patients. Recognizing that this is a rapidly evolving situation and that limited oncology-specific, evidence-based information is available, we are committed to sharing what is known and acknowledging what is unknown so that the most informed decisions can be made.

To help guide oncology professionals as they deal with the impact of coronavirus on both their patients and staff, ASCO has collated questions from its members, posted responses at asco.org and assembled a compendium of additional resources we hope will be helpful as the virus spreads and the disease unfolds. We continue to receive additional questions regarding clinical care and we are updating our FAQs on a regular basis.

We hope this information is helpful even when it merely confirms that there are no certain answers to many questions. Our answers are based on the best available information we identify in the literature, guidance from public health authorities, and input received from oncology and infectious disease experts.

For patients, we have posted a blog by Dr. Merry Jennifer Markham, chair of ASCO’s Cancer Communications Committee. This can be found on Cancer.Net, ASCO’s patient information website, and it provides practical guidance to help patients reduce their risk of exposure, better understand COVID-19 symptoms, and locate additional information.

This blog is available both in English and Spanish. Additional blog posts addressing patient questions will be posted as new questions are received and new information becomes available.

Find below a Tweet from Dr.Markham which includes links to her article on COVID-19 for cancer patients

https://twitter.com/DrMarkham/status/1237797251038220289?s=20

NCCN’s Response to COVID-19 and COVID-19 Resources

JNCCN: How to Manage Cancer Care during COVID-19 Pandemic

Experts from the Seattle Cancer Care Alliance (SCCA)—a Member Institution of the National Comprehensive Cancer Network® (NCCN®)—are sharing insights and advice on how to continue providing optimal cancer care during the novel coronavirus (COVID-19) pandemic. SCCA includes the Fred Hutchinson Cancer Research Center and the University of Washington, which are located in the epicenter of the COVID-19 outbreak in the United States. The peer-reviewed article sharing best practices is available for free online-ahead-of-print via open access at JNCCN.org.

Coronavirus disease 2019 (COVID-19) Resources for the Cancer Care Community

NCCN recognizes the rapidly changing medical information relating to COVID-19 in the oncology ecosystem, but understands that a forum for sharing best practices and specific institutional responses may be helpful to others.  Therefore, we are expeditiously providing documents and recommendations developed by NCCN Member Institutions or Guideline Panels as resources for oncology care providers. These resources have not been developed or reviewed by the standard NCCN processes, and are provided for information purposes only. We will post more resources as they become available so check back for additional updates.

Documents

Links

National Cancer Institute Response to COVID-19

More information at https://www.cancer.gov/contact/emergency-preparedness/coronavirus

What people with cancer should know: https://www.cancer.gov/coronavirus

Get the latest public health information from CDC: https://www.coronavirus.gov

Get the latest research information from NIH: https://www.nih.gov/coronavirus

 

Coronavirus: What People with Cancer Should Know

ON THIS PAGE

Both the resources at cancer.gov (NCI) as well as the resources from ASCO are updated as new information is evaluated and more guidelines are formulated by members of the oncologist and cancer care community and are excellent resources for those living with cancer, and also those who either care for cancer patients or their family and relatives.

Related Resources for Patients (please click on links)

 

 

 

Some resources and information for cancer patients from Twitter

Twitter feeds which may be useful sources of discussion and for cancer patients include:

 

@OncLive OncLive.com includes healthcare information for patients and includes videos and newsletters

 

 

@DrMarkham Dr. Markham is Chief of Heme-Onc & gyn med onc @UF | AD Med Affairs @UFHealthCancer and has collected very good information for patients concerning #Covid19 

 

 

@DrMaurieMarkman Dr. Maurie Markman is President of Medicine and Science (Cancer Centers of America, Philadelphia) @CancerCenter #TreatThePerson #Oncology #Genomics #PrecisionMedicine and hosts a great online live Tweet feed discussing current topics in cancer treatment and care for patients called #TreatThePerson Chat

UPDATED 3/20/2020 INFORMATION FROM NCI DESIGNATED CANCER CENTERS FOR PATIENTS/PROVIDERS

The following is a listing with links of NCI Designated Comprehensive Cancer Centers and some select designated Cancer Centers* which have information on infectious risk guidance for cancer patients as well as their physicians and caregivers.   There are 51 NCI Comprehensive Cancer Centers and as more cancer centers formulate guidance this list will be updated. 

 

Cancer Center State Link to COVID19 guidance
City of Hope CA Advice for cancer patients, survivors and caregivers
Jonsson Cancer Center at UCLA CA Cancer and COVID19
UCSF Hellen Diller Family Comprehensive Cancer CA COVID-19 Links for Patients and Providers
Lee Moffit FL Protecting against Coronavirus 19
University of Kansas Cancer Center* KS COVID19 Info for patients
Barbara & Karmanos Cancer Institute (Wayne State) MI COVID19 Resources
Rogel Cancer Center (Univ of Michigan) MI COVID19 Patient Specific Guidelines
Alvin J. Siteman Cancer Center (MO) Coronavirus
Fred & Pamela Buffet CC* NE Resources for Patients and Providers
Rutgers Cancer Institute of NJ NJ What patients should know about COVID19
Memorial Sloan Kettering NY What COVID19 means for cancer patients
Herbert Irving CC (Columbia University) NY Coronavirus Resource Center
MD Anderson Cancer  TX Planning for Patients, Providers
Hunstman Cancer Center UT COVID19 What you need to know
Fred Hutchinson WA COVID19 What patients need to know

 

 

Please also see related information on Coronavirus 2019 and Cancer and Immunotherapy at the following links on the Open Access Online Journal:

Volume Two: Cancer Therapies: Metabolic, Genomics, Interventional, Immunotherapy and Nanotechnology in Therapy Delivery 

at

https://pharmaceuticalintelligence.com/biomed-e-books/series-c-e-books-on-cancer-oncology/volume-two-immunotherapy-in-cancer-radiation-oncology/

AND

Coronavirus Portal

 

 

 

 

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NIH SBIR Funding Early Ventures: September 26, 2018 sponsored by Pennovation

Stephen J. Williams PhD, Reporter

Penn Center for Innovation (Pennovation) sponsored a “Meet with NCI SBIR” program directors at University of Pennsylvania Medicine Smilow Center for Translational Research with a presentation on advice on preparing a successful SBIR/STTR application to the NCI as well as discussion of NCI SBIR current funding opportunities.   Time was allotted in the afternoon for one-on-one discussions with NCI SBIR program directors.

To find similar presentations and one-on-one discussions with NCI/SBIR program directors in an area nearest to you please go to their page at:

https://sbir.cancer.gov/newsevents/events

For more complete information on the NCI SBIR and STTR programs please go to their web page at: https://sbir.cancer.gov/about

A few notes from the meeting are given below:

  • In 2016 the SBIR/STTR 2016 funded $2.5 billion (US) of early stage companies; this is compared to the $6.6 billion invested in early  stage ventures by venture capital firms so the NCI program is very competitive with alternate sources of funding
  • It was stressed that the SBIR programs are flexible as far as ownership of a company; SBIR allows now that >50% of the sponsoring company can be owned by other ventures;  In addition they are looking more favorably on using outside contractors and giving leeway on budgetary constraints so AS THEY SUGGEST ALWAYS talk to the program director about any questions you may have well before (at least 1 month) you submit. More on eligibility criteria is found at: https://sbir.cancer.gov/about/eligibilitycriteria
  • STTR should have strong preliminary data since more competitive; if don’t have enough go for  an R21 emerging technologies grant which usually does not require preliminary data
  • For entities outside the US need a STRONG reason for needing to do work outside the US

Budget levels were discussed as well as  the waiver program, which allows for additional funds to be requested based on criteria set by NCI (usually for work that is deemed high priority or of a specialized nature which could not be covered sufficiently under the standard funding limits) as below:

Phase I: 150K standard but you can get waivers for certain work up to 300K

Phase II: 1M with waiver up to 2M

Phase IIB waiver up to 4M

You don’t need to apply for the waiver but grant offices may suggest citing a statement requesting a waiver as review panels will ask for this information

Fast Track was not discussed in the presentation but for more information of the Fast Track program please visit the website  

NCI is working hard to cut review times to 7 months between initial review to funding however at beginning of the year they set pay lines and hope to fund 50% of the well scored grants

NCI SBIR is a Centralized system with center director and then program director with specific areas of expertise: Reach out to them

IMAT Program and Low-Resource Setting new programs more suitable for initial studies and also can have non US entities

Phase IIB Bridge funding to cross “valley of death” providing up to 4M for 2-3 years: most were for drug/biological but good amount for device and diagnostics

 

Also they have announced administrative supplements for promoting diversity within a project: can add to the budget

FY18 Contracts Areas

3 on biotherapies

2 imaging related

2 on health IT

4 on radiation therapy related: NOTE They spent alot of time discussing the contracts centered on radiation therapy and seems to be an area of emphasis of the NCI SBIR program this year

4 other varied topics

 

Breakdown of funding

>70% of NCI SBIR budget went to grants (for instance Omnibus grants); about 20-30% for contracts; 16% for phase I and 34 % for phase II ;

ALSO the success rate considerably higher for companies that talk to the program director BEFORE applying than not talking to them; also contracts more successful than Omnibus applications

Take Advantage of these useful Assistance Programs through the NIH SBIR Program (Available to all SBIR grantees)

NICHE ASSESSMENT Program

From the NCI SBIR website:

The Niche Assessment Program is designed to help small businesses “jump start” their commercialization efforts. All active HHS (NIH, CDC, FDA) SBIR/STTR Phase I awardees and Phase I Fast-Track awardees (by grant or contract) are eligible to apply. Registration is on a first-come, first-serve basis!

The Niche Assessment Program provides market insight and data that can be used to help small businesses strategically position their technology in the marketplace. The results of this program can help small businesses develop their commercialization plans for their Phase II application, and be exposed to potential partners. Services are provided by Foresight Science & Technology of Providence, RI.

Technology Niche Analyses® (TNA®) are provided by Foresight, for one hundred and seventy-five (175), HHS SBIR/STTR Phase I awardees. These analyses assess potential applications for a technology and then for one viable application, it provides an assessment of the:

  1. Needs and concerns of end-users;
  2. Competing technologies and competing products;
  3. Competitive advantage of the SBIR/STTR-developed technology;
  4. Market size and potential market share (may include national and/or global markets);
  5. Barriers to market entry (may include but is not limited to pricing, competition, government regulations, manufacturing challenges, capital requirements, etc.);
  6. Market drivers;
  7. Status of market and industry trends;
  8. Potential customers, licensees, investors, or other commercialization partners; and,
  9. The price customers are likely to pay.

Commercialization Acceleration Program  (CAP)

From the NIH SBIR website:

NIH CAP is a 9-month program that is well-regarded for its combination of deep domain expertise and access to industry connections, which have resulted in measurable gains and accomplishments by participating companies. Offered since 2004 to address the commercialization objectives of companies across the spectrum of experience and stage, 1000+ companies have participated in the CAP. It is open only to HHS/NIH SBIR/STTR Phase II awardees, and 80 slots are available each year. The program enables participants to establish market and customer relevance, build commercial relationships, and focus on revenue opportunities available to them.

I-Corps Program

The I-Corps program provides funding, mentoring, and networking opportunities to help commercialize your promising biomedical technology. During this 8-week, hands-on program, you’ll learn how to focus your business plan and get the tools to bring your treatment to the patients who need it most.

Program benefits include:

  • Funding up to $50,000 to cover direct program costs
  • Training from biotech sector experts
  • Expanding your professional network
  • Building the confidence and skills to create a comprehensive business model
  • Gaining years of entrepreneurial skills in only weeks.

 

ICORPS is an Entrepreneurial Program (8 week course) to go out talk to customers, get assistance with business models, useful resource which can guide the new company where they should focus on for the commercialization aspect

THE NCI Applicant Assistance Program (AAP)

The SBIR/STTR Applicant Assistance Program (AAP) is aimed at helping eligible small R&D businesses and individuals successfully apply for Phase I SBIR/STTR funding from the National Cancer Institute (NCI), National Institute for Neurological Disorders and Stroke (NINDS), National Heart, Lung and Blood Institute (NHLBI). Participation in the AAP will be funded by the NCI, NINDS, and NHLBI with NO COST TO PARTICIPANTS. The program will include the following services:

  • Needs Assessment/Small Business Mentoring
  • Phase I Application Preparation Support
  • Application Review
  • Team/Facilities Development
  • Market Research
  • Intellectual Property Consultation

For more details about the program, please refer to NIH Notice NOT-CA-18-072.

 

These programs are free for first time grant applicants and must not have been awarded previous SBIR

Peer Learning Webinar Series goal to improve peer learning .Also they are starting to provide Regulatory Assistance (see below)

NIH also provides Mentoring programs for CEOS and C level

Application tips

  1. Start early: and obtain letters of collaboration
  2. Build a great team: PI multi PI, consider other partners to fill gaps (academic, consultants, seasoned entrepreneurs (don’t need to be paid)
  3. They will pre review 1 month before due date, use NIH Project Reporter to view previous funded grants
  4. Specify study section in SF to specify areas of expertise for review
  5. Specific aims are very important; some of the 20 reviewers focus on this page (describes goals and milestones as well; spend as much time on this page as the rest of the application
  6. Letters of support from KOLs are important to have; necessary from consultants and collaborators; helpful from clinicians
  7. Have a phase II commercialization plan
  8. Note for non US clinical trials:  They will not fund nonUS clinical trials; the company must have a FWA
  9. SBIR budgets defined by direct costs; can request a 7% fee as an indirect cost; and they have a 5,000 $ technical assistance program like regulatory consultants but if requested can’t participate in NIH technical assistance programs so most people don’t apply for TAP

 

  • They are trying to change the definition of innovation as also using innovative methods (previously reviewers liked tried and true methodology)

10.  before you submit solicit independent readers

NCI SBIR can be found on Twitter @NCIsbir ‏

Discussion with Monique Pond, Ph.D. on Establishment of a Regulatory Assistance Program for NCI SBIR

I was able to sit down with Dr. Monique Pond,  AAAS Science & Technology Policy Fellow, Health Scientist within the NCI SBIR Development Center to discuss the new assistance program in regulatory affairs she is developing for the NCI SBIR program.  Dr Pond had received her PhD in chemistry from the Pennsylvania State University, completed a postdoctoral fellow at NIST and then spent many years as a regulatory writer and consultant in the private sector.  She applied through the AAAS for this fellowship and will bring her experience and expertise in regulatory affairs from the private sector to the SBIR program. Dr. Pond discussed the difficulties that new ventures have in formulating regulatory procedures for their companies, the difficulties in getting face time with FDA regulators and helping young companies start thinking about regulatory issues such as pharmacovigilence, oversight, compliance, and navigating the complex regulatory landscape.

In addition Dr. Pond discussed the AAAS fellowship program and alternative career paths for PhD scientists.

 

A formal interview will follow on this same post.

 

Other articles on this OPEN ACCESS JOURNAL on Funding for Startups and Early Ventures are given below:

 

Mapping Medical Device Startups Across The Globe per Funding Criteria

Funding Oncorus’s Immunotherapy Platform: Next-generation Oncolytic Herpes Simplex Virus (oHSV) for Brain Cancer, Glioblastoma Multiforme (GBM)

 

Funding Opportunities for Cancer Research

 

Team Profile: DrugDiscovery @LPBI Group – A BioTech Start Up submitted for Funding Competition to MassChallenge Boston 2016 Accelerator

 

A Message from Faculty Director Lee Fleming on Latest Issue of Crowdfunding; From the Fung Institute at Berkeley

 

PROTOCOL for Drug Screening of 3rd Party Intellectual Property Presented for Funding Representation

 

Foundations as a Funding Source

 

The Bioscience Crowdfunding Environment: The Bigger Better VC?

 

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AACR and Philly New Media Present a Town Hall Discussion on Precision Medicine

Cancer Precision Medicine: Big Ideas in Research, Treatment, and Prevention

A Town Hall Forum will discuss the latest findings with regard to precision medicine, its impact currently in cancer treatment, and future directions, discussed by some of the preeminent cancer researchers and oncologists in the country. This unprecedented event is being hosted by the American Association for Cancer Research (AACR) and Philadelphia Media Network – publisher of The Philadelphia Inquirer, Daily News, and Philly.com.

Given the following speakers, this event will have a large focus on use of cancer immunotherapy as well as new targets in the precision medicine arena.

Register today: Philly.com/CancerEvent – Use the promo code “AACR” for discounted $45 tickets.

When: Thursday, January 21, 2016 • Program: 2 pm • Networking reception: 5:30 pm.

Where:  The College of Physicians of Philadelphia • 19 South 22nd Street, Philadelphia, Pa.

The event will be held in Philadelphia at the College of Physicians of Philadelphia, home of the famous Mutter Museum.

Please follow the meeting coverage on @pharma_BI and using the following @ handle and # hastags of Twitter:

@AACR

@pharma_BI

@PhillyInquirer

#cbi16

#precisionmedicine

#endcancer

 

From Penn Medicine News Blog: Archives (please click on link below)

Penn’s Center for Personalized Diagnostics (CPD), which recently named Kojo S.J. Elenitoba-Johnson, MD, as its founding director, is diving deeper into cancer patients’ tumors with next generation DNA sequencing.

The genetic tests help refine diagnoses with greater precision than standard imaging tests and blood work by spotting known mutations that can inform the treatment plan. Since it launched in February 2013, the CPD has performed more than 4,000 advanced diagnostics, representing a wide range of cancers.  It’s also producing actionable findings: Of those tests, 75 percent found disease-associated mutations, revealing possible new treatment pathways.

This new CPD video helps breakdown how the process works, but a patient story can really help connect the dots. We’ve written about several people who benefited from the CPD, including one acute myeloid leukemia patient with an FLT3 mutation that made her a candidate for a targeted therapy, and another whose cholangiocarcinoma was successfully treated with a BRAF-targeted therapy after the mutation—typically associated with melanoma—was spotted.

ACC’s role as a national leader in personalized cancer care was also reinforced with the opening of the Center for Rare Cancers and Personalized Therapy in 2015.

Directed by Marcia Brose, MD, PhD, this virtual center enrolls patients into clinical trials based on genetic markers rather than tumor origin.  Patients with the same mutation, BRAF for instance, but different cancers, are part of the same clinical study investigating a targeted therapy.  A story, set to air on TV news affiliates across the country in the upcoming weeks, will feature a patient with a rare salivary tumor who ran out of treatment options, until a HRAS mutation identified through the CPD put him back on track, after switching to the drug tipifarnib. The patient responded well, and a recent scan revealed that his disease has stabilized.

“Philadelphia is a hotbed for healthcare innovation and groundbreaking scientific research—which becomes even more apparent as the ACC continues to move the needle in the precision medicine world,”Abramson Cancer Center (ACC) director Chi Van Dang, MD, PhD, said.  “Quickly evolving diagnostics and genetic tests, cancer vaccines, and powerful personalized therapies that use the body’s own immune system to fight off cancer: These are just a few of the medical advances being utilized today that are giving patients the greatest chance.”

For Media Inquiries see the following AACR contact information:

Julia Gunther
Assistant Director, Media and Public Relations
215-446-6896
Cell: 267-250-5441
Fax: 215-861-5937
julia.gunther@aacr.org
Gunther promotes the AACR’s meetings, journals, and initiatives to the media and the public.

Lauren Walens
Senior Manager, Media and Public Relations
215-446-7163
Fax: 267-765-1050
lauren.walens@aacr.org
Walens promotes the AACR’s meetings, journals, and initiatives to the media and the public. She also manages the AACR’s blog, Cancer Research Catalyst.

Lauren Riley
Senior Coordinator, Media and Public Relations
215-446-7155
Fax: 215-446-7291
lauren.riley@aacr.org
Riley is responsible for media relations promotion and support, conference newsroom logistics, writing and proofreading, website and news release copy, as well as office support for the Communications and Public Relations Department staff.

 

 

 

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Early Diagnosis

Reporter: Stephen J. Williams, Ph.D.

This post contains a curation of all Early Diagnosis posts on this site as well as a curation of the Early Detection Research Network.

Early Research Detection Network (EDRN)

Welcome to EDRN

The Early Detection Research Network (EDRN), an initiative of the National Cancer Institute (NCI), brings together dozens of institutions to help accelerate the translation of biomarker information into clinical applications and to evaluate new ways of testing cancer in its earliest stages and for cancer risk.

Getting Started…

Check out the EDRN Highlights — a listing of our accomplishments and milestones.

 

► Scientific Components ► For Public, Patients, Advocates
► Collaborative Opportunities (how to join EDRN) ► For Researchers

Highlights

Highlights of the accomplishments of the Early Detection Research Network.

A brief list of major EDRN-developed assays that have been adapted for clinical use is described in the table below:

Detection/Biomarker Assay Discovery Refine/Adapt for Clin Use Clinical Validation Clinical Translation
Blood proPSA FDA approved
Urine PCA3 FDA approved
OVA1™ for Ovarian Cancer FDA approved
ROMA Algorithm for CA125 and HE4 Tests for Pelvic Mass Malignancies FDA approved
Blood/DCP and AFP-L3 for Hepatocellular Carcinoma FDA approved
Blood GP73 Together with AFP-L3 used  for monitoring cirrhotic patients for HCC in China
MiPS (Mi Prostate Score Urine test), Multiplex analysis of T2-ERG gene fusion, PCA3 and serum PSA In CLIA Lab
FISH to detect T2S:Erg fusion for Prostate Cancer In CLIA Lab
GSTP1 methylation for repeat biopsies in prostate cancer In CLIA Lab
Mitochondrial deletion for detection of prostate cancer In CLIA Lab
Somalogic 12-marker panel for Lung Cancer In CLIA Lab
80-gene panel for Lung Cancer In CLIA Lab
Vimentin Methylation Marker for Colon Cancer In CLIA Lab
Galectin-3 ligand for detection of adenomas and colon cancer In CLIA Lab
8-gene panel for Barrett’s Esophagus In CLIA Lab
SOPs for Blood (Serum, Plasma), Urine, Stool Frequently used by biomarker research community
EDRN Pre/Validation Specimen Reference Sets (specimens from well characterized and matched cases and controls from specific disease spectra) Frequently used by biomarker research community

Since its inception in 1999 EDRN has achieved several key milestones, summarized below:

1998 through 2000: Inception and Inauguration of EDRN

2001 to 2003: Meeting the Challenges to Harness and Share Emerging Scientific Knowledge

  • EDRN Second Report, Translational Research to Identify Early Cancer and Cancer Risk, October 2002, http://edrn.nci.nih.gov/docs.) published.
  • EDRN joined the Gordon Research Conferences to co-host the New Frontiers in Cancer detection and Diagnosis in 2002.

 

  • Guidelines Set for Studies Measuring Biomarker Predictive Power Journal of National Cancer Institute (Vol. 93, No. 14, July 18, 2001).
  • EDRN Associate Membership Program Initiated: This novel approach to make EDRN inclusive has been extremely successful. EDRN has now more than 120 Associate Members who are significantly contributing to EDRN efforts in biomarker discovery, development and validation.

2003 to 2004: Network Surges Ahead in Real-time

  • Collaborative Discovery and Validation Projects:  More than 100 collaborative projects spanned the various organ sites. These projects are monitored through the EDRN’s electronic System Information System (eSIS).
  • EDRN Virtual Specimen Bank and Validation Management System Launched: The EDRN Virtual Specimen Bank, also known as ERNE knowledge system, was deployed to 10 institutions in early 2003, allowing a common web-based query to search for available specimens across the EDRN Clinical Epidemiology and Validation Centers https://ginger.fhcrc.org/edrn/imp/GateServlet?pwd. VSIMS was created to allow multiple studies to be administered efficiently by minimizing development time with standardization of information and data management across multiple activities and research sites. This system encompasses all the security features of Food and Drug Administration (FDA)-required auditing systems.
  • Partnership on the Plasma Proteome Project (PPP) Initiative of the Human Proteome Organization (HUPO): PPP project was initiated to evaluate multiple technology platforms, develop bioinformatic tools and standards for protein identification, and create a database of the plasma proteome. The entire study was published in the August issue of the journal Proteomics August 2005, Volume 4 (4), pp 1045-1450.

2005 to 2008: An Investment in Prevention

  • In late 2006, EDRN’s Program for Rapid, Independent Diagnostic Evaluation (PRIDE), was established (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-07-003.html ) as an administrative means to assist extramural investigators in successfully conducting cross-laboratory validation of biomarkers. Ten applications have been reviewed and five are being supported.
  • EDRN underwent external reviews in 2007 and 2008.
  • The Canary Foundation, Palo Alto, CA signed a Memorandum of Understanding with EDRN, NCI on supporting prostate cancer surveillance network of investigators from seven institutions. The tissue and serum will be collected during a three-year period and will be made available to extramural scientists for discovery and validation research.
  • The Lustgarten Foundation, N.Y., funded 6 institutions to generate monoclonal antibodies and associated hybridoma cell lines for pancreatic cancer antigens (biomarkers) identified by EDRN and non-EDRN investigators. These resources will be stored at the NCI-Frederick Facility for distribution to extramural investigators.

2009 to 2011: Realizing Investment for Clinical Use

  • Two biomarker tests approved by FDA and two IVDs pending FDA review.
  • Six biomarker tests offered by CLIA labs.
  • One biomarker test approved for clinical use outside the USA

A Curation of Posts on Early Detection of Cancer and Other Early Detection Networks is Included Below

 

BRCA 1 and 2 and Early Detection of Cancer

Early Detection of Prostate Cancer: American Urological Association (AUA) Guideline

Mechanism involved in Breast Cancer Cell Growth: Function in Early Detection & Treatment

Warning signs may lead to better early detection of ovarian cancer

Cancer Detection

Biomarker tool development for Early Diagnosis of Pancreatic Cancer: Van Andel Institute and Emory University

China, India, and Russia account for 46% of all new cancer cases globally, as well as 52% of cancer-related mortality per 4/2014 Lancet Oncology article

 

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Life Sciences Circle Event: Next omics – Personalized Medicine beyond Genomics, December 11, 2013 5:30-8:30PM, The Broad Institute, Cambridge

Reporter: Aviva Lev-Ari, PhD, RN

December 11, 2013: 5:30pm – 8:30pm

 Over the past decade, the genomics revolution has led to the creation of numerous groundbreaking personalized therapies as well as multiple diagnostic and therapeutic targets.  But what will the next field of biology be similar to that which created the genomics revolution? Join us to learn from thought leaders of several Cambridge-based “’omics” companies and institutions as they discuss their role in improving therapeutic effectiveness, realizing potential reductions in adverse effects,  and the related promises of cost-effectiveness and efficiencies associated with these advances.  We will gain insight from viewing the unique application of epigenetics, metabolomics, microbiomics, proteomics and more from these players to address our individual targeted medical needs and challenges.  What are the challenges of commercializing new technologies and new areas of basic biological research?   Will the next group of ‘omics contribute to the future of personalized therapies and ultimately improve healthcare outcomes and cost-effectiveness in our complex, expensive healthcare system?
Register

Panelists:

Clary Clish, PhD, Director of Metabolite Profiling, Broad Institute

Bernat Olle, PhD, Principal, PureTech

Robert Copeland, PhD, Executive Vice President and Chief Scientific Officer, Epizyme, Inc.

Edward Driggers, PhD, Senior Director, Cell Metabolism, Agios Pharmaceuticals, Inc.

http://www.mitforumcambridge.org/events/life-sciences-circle-event-next-omics-personalized-medicine-beyond-genomics/

 

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Pancreatic Cancer Diagnosis: Four Novel Histo-pathologies Screening Characteristics offers more Reliable Identification of Cellular Features associated with Cancer

News from University of Missouri, School of Medicine

Reporter: Aviva Lev-Ari, PhD, RN

“Through our analysis, we developed a group of four characteristics that allow a pathologist to diagnose pancreatic cancer with 93 percent accuracy — a substantial improvement over the traditional method,” Layfield said. “I believe this new technique can help pathologists improve the diagnosis of pancreatic cancer, ultimately improving care for patients by providing an evidence-based approach to diagnosing the disease and determining the best treatment.”

The four features of pancreatic cancer the researchers identified are:

  • a wide variation in the size of pancreatic cells’ nuclei, called anisonucleosis
  • oversized nucleoli, called macronucleoli
  • single atypical epithelia cells, a type of cell found in the pancreas
  • mucinous metaplasia, which is the production of mucin in cells that normally don’t produce the substance

The study, “Risk Stratification Using Morphological Features in Endoscopic-ultrasonography Guided Fine Needle Aspirations of Pancreatic Ductal Adenocarcinoma,” was presented at the American Society for Clinical Pathology‘s 2013 annual meeting.

MU Study Finds More Accurate Method to Diagnose Pancreatic Cancer

Group of four screening characteristics offers more reliable identification

Researchers from the University of Missouri have found a more accurate laboratory method for diagnosing pancreatic cancer, the fourth leading cause of cancer death in the United States. The disease causes more than 38,000 deaths each year in the United States, and kills 94 percent of people with the illness within five years, according to the National Cancer Institute.

Layfield
Layfield

“Pancreatic cancer can be difficult to diagnose because of subtle differences that distinguish between healthy tissue, cancerous tissue and tissue that is atypical, or suspicious,” said Lester Layfield, MD, professor and chair of the MU School of Medicine’s Department of Pathology and Anatomical Sciences. “Our goal was to find a way to make a more accurate and reproducible diagnosis.”

Because of the pancreas’ location within the body, no routine screening methods, such as mammography for breast cancer, exist for detecting pancreatic cancer.

If a physician suspects a patient may have pancreatic cancer, a biopsy of the pancreatic tissue is taken through a minimally invasive technique called endoscopic ultrasound-guided fine-needle aspiration.

“Traditionally, pathologists have examined a tissue sample through a microscope and made a diagnosis based on the overall features of all the cells in the tissue sample,” Layfield said. “Previous research has shown an experienced pathologist can diagnose pancreatic cancer with accuracy in the mid-to-upper 80 percent range using current techniques. However, we wanted to develop a more accurate method by determining which cellular features are most closely associated with cancer.”

To develop the new diagnostic method, MU researchers performed a retrospective study of the records from 57 patients at University of Missouri Health Care who were tested for pancreatic cancer. They evaluated 16 features of pancreatic biopsies that could be evaluated under a microscope and performed a statistical analysis to determine which could be most reliably identified by multiple pathologists and which were most likely to be associated with pancreatic cancer.

SOURCE

http://medicine.missouri.edu/news/0208.php?elq=0fef1d5f8bdf48c59a79cd939bd95e46&elqCampaignId=9

 

 

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Einstein Center Reaps $17M from NCI for Infrastructure, Research Support

Reporter: Aviva Lev-Ari, PhD, RN

September 27, 2013

NEW YORK (GenomeWeb News) – The Albert Einstein Cancer Center (AECC) at Yeshiva University has received a $16.7 million grant from the National Cancer Institute to provide for support and infrastructure of its research programs, which involve a range of molecular, genomics, imaging, and related disciplines.

The funding will bolster research projects in five major areas at AECC, including studies of the tumor microenvironment and metastasis; stem cells, differentiation and cancer; experimental therapeutics; cancer epidemiology; and the biology of colon cancer, AECC said yesterday.

Supporting these research programs are 14 specialized shared resource facilities involving genomics, proteomics, biostatistics and bioinformatics, structural biology, transgenic mouse resource, and others. The new funding also would provide for a new shared resource, a cancer biospecimen and acquisition biorepository.

AECC’s genomics facility provides a range of sequencing services , including massively-parallel assays for expression, resequencing and de novo sequencing; gene expression, exon, and SNP arrays from Affymetrix; SNP typing, CpG methylation, and gene expression from Sequenom; real-time PCR using Sybr Green and Taqman assays; DNA purification; pyrosequencing, and others.

The proteomics core lab provides protein identification services; analysis of small proteins; spatial localization of molecules by mass spectrometry; quantitative proteomics; confirmation of synthetic and recombinant molecules, and multiple reaction monitoring assays and pharmacokinetics, among others.

AECC said its location in the Bronx, New York, provides its researchers with access to samples from and studies of diverse ethnic and racial populations, making it “a national resource.”

 

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AACR announces AACR Progress Report 2013

Stephen J. Williams: Curator

The American Association for Cancer Research (AACR) presented a webinar of the highlights of their yearly progress report (released yesterday and available on the AACR website) on the recent advances and current status of cancer research and cancer research’s impact on health outcomes in the United States.  This report, compiled by staff of AACR, with special thanks to the efforts of Dr. Karen Honey, Ph.D, reports on the current achievements in cancer research including developments in immunotherapies, new drug approvals, health outcomes, newly approved imaging modalities, and the current state of affairs of funding for cancer research and clinical trials.  The report also describes the impact and timeline of discoveries leading to the use of genomics and personalized medicine in cancer treatment.  The last portion of the report is an “AACR Call to Action”, imploring cancer patient activists, scientists, and citizens to write their representatives in Washington for increased funding for cancer research and clinical trials.  The report and presentation will be given to lawmakers on Capital Hill on Spetmeber 19, 2013 as part of Hill Day’s Rally for Medical Research.

The presentation, given on September 18, 2013 at the National Press Club in Washington DC) was headed by AACR CEO Dr. Marge Foti, M.D., Ph.D. with presentations given by

  • Dr. Charles Sawyers, M.D. (Memorial Sloan Kettering)
  • Dr. Drew M. Pardoll, M.D., Ph.D. (Sidney Kimmel Cancer Center, Johns Hopkins)
  • 3 cancer survivors

Below is a brief summary of each of their talks.  The downloadable AACR Progress Report 2013 can be found here and a link to the video can also be found at the AACR website.

Marge Foti, M.D., Ph.D. (Chief Executive Officer, American Association Cancer Research)

Although Dr. Foti mentioned the grim statistic in the US 580,000 this year will die of cancer, she gave multiple statistics on the great progress the US has achieved since staring the “War on Cancer” in 1971 and the future progress which lies ahead.  Notably (from the report)

  • From 1990 to 2012 over 1 million cancer patients lives have been saved
  • There are over 13 million cancer survivors today
  • For the year 2012-2013 FDA has approved
  1. 11 new cancer drugs
  2. 3 new uses of previously approved drugs
  3. 3 new imaging modalities and protocols for cancer detection

However Dr. Foti also stressed the speed of progress is being pressured by diminishing federal funds for cancer research and clinical trials.  Dr. Foti noted:

  • In mid 90’s there was a doubling of federal funds to the NCI
  • Since 2003 however funding has not kept up with “biomedical inflation” (not risen adjusted for current inflation)
  • Sequester has been a big pressure on biomedical and cancer research capacity
  • Funding cuts also decrease the number of patients that can enroll in clinical trials

Charles Sawyers, M.D. (Howard Hughes Medical Institute investigator and Director at Memorial Sloan-Lettering Cancer Center)

Dr. Sawyers’s research work involves the signaling pathways involved in conferring growth advantage to cancerous cells.  His work led to the development of numerous targeted therapies such as imatinib (Gleevec) for CML (chronic myeloid leukemia).  He referred to these therapies as “precision medicine” and noted there were only 5 such therapies 10 years ago but now 17 such precision medicines five years ago for cancer, “ a complex host of diseases”.

Dr. Sawyers reflected this is the “most serious funding crisis in decades” and we are “already losing momentum” due to the current funding crisis.

Drew M. Pardoll, M.D. Ph.D. (Professor, Co-Director Division Immunology, Johns Hopkins)

Dr. Pardoll is a leader in the fielod of immunotherapy for cancer and his work is pioneering a new clas of immunotherapies, such as PD1 inhibitors, which supports the cancer patient’s own immune system to fight and kill the patient’s own cancer cells.  Dr. Pardoll had mentioned early work on immunotherapy had revealed its potential but researchers are now realize this is the “5th pillar of cancer therapy”.  Because of research done in the early 2000’s, cancer researchers such as Dr. Pardoll figured out mechanisms how to make these immunotherapies more reproducible in clinical trials.  This led to the discovery of CTLA4 and PD1 as major regulators of the immune tolerance to cancer cells (see post Combined anti-CTLA4 and anti-PD1 immunotherapy shows promising results against advanced melanoma).

Dr. Pardoll also mentioned how he, and others, noticed that the pharmaceutical industry is now looking to academia to keep driving the science and that patient advocates are very important partner in the discovery process.

Moving presentation were also given by three cancer survivors (breast cancer, ovarian cancer, and  childhood leukemia) which all attested that without ground-breaking clinical research they might not have survived their deadly cancer.

Please see the following website below about the Rally for Medical Research to see how you can get involved in supporting cancer research in the US, and contacting your representative.

Rally for Medical Research Hill Day

September 18, 2013

Federal funding for medical research is in jeopardy, threatening the health of Americans. On September 18, 2013, a broad coalition of groups from the medical research advocacy community will meet with House and Senate offices in Washington, D.C., to urge Congress to invest in the National Institutes of Health for the health and economic security of our nation.

Sponsoring organizations will join the Rally for Medical Research Hill Day to raise awareness during a critical time about the urgent need for a sustained investment in the NIH to improve health, spur more progress, inspire more hope and save more lives.

More articles on Progress on the War on Cancer from this site include:

2013 Perspective on “War on Cancer” on December 23, 1971

2013 American Cancer Research Association Award for Outstanding Achievement in Chemistry in Cancer Research: Professor Alexander Levitzki

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Reporter: Aviva Lev-Ari, PhD, RN

CT Scanner Delivers Less Radiation

Faster, more sensitive scans and better image processing may reduce the risk of x-ray-related cancers.

 WHY IT MATTERS

A new CT scanner exposes patients to less radiation while providing doctors with clearer images to help with diagnoses, according to researchers at the National Institutes of Health.

“CT” stands for Computerized Tomography, which involves combining lots of x-ray images taken from different angles into a three-dimensional view of what’s inside the body. The technology can be especially useful for diagnoses in emergency situations, and the number of CT scans in recent years has increased dramatically, says Marcus Chen, a cardiovascular imager at the National Heart, Lung and Blood Institute, in Bethesda, Maryland.  But the increase in the use of CT scans raises concerns about the amount of radiation to which patients are exposed, says Chen.

The risk of developing cancer from the radiation delivered by one CT scan is low, but the large number of scans performed each year—more than 70 million—translates to a significant risk. Researchers at the National Cancer Institute estimated that the 72 million CT scans performed in the U.S. in 2007 could lead to 29,000 new cancers. On average, the organ studied in a CT scan of an adult receives around 15 millisieverts of radiation, compared with roughly 3.1 millisieverts of radiation exposurefrom natural sources each year.

This concern has led researchers to seek ways to reduce the amount of radiation exposure a patient receives in a scan. They are working to improve both hardware, to make the scans go faster and need less repetition, and software, to process the x-ray data better (see “Clear CT Scans with Less Radiation”).

The new CT scanning system, from Toshiba Medical, combines several improvements to reduce radiation exposure. The overall body of a CT scanner is shaped like a large ring. An x-ray tube and a detector spin separately in the ring, opposite one another, and a patient lies in the center.  X-rays travel through the patient as they are delivered by the tube and captured by the detectors. The new Toshiba machine has five times as many detectors as most machines, which means that more of an organ can be captured at a time, decreasing the number of passes of the scanner required.

The x-ray components in the new system also spin faster—it takes only 275 milliseconds for them to complete a rotation, instead of 350 millisesconds—which means a patient gets irradiated for less time. In cases where doctors are looking at a moving organ such as the heart, the faster spinning also reduces the number of times a doctor may need to try to get a good image. “It’s like having faster film in your camera,” says Chen.  Changes to the way the system generates x-rays and computes the images also mean patients spend less time getting hit with radiation.

Chen and colleagues at the National Heart Lung and Blood Institute used the Toshiba system to examine 107 adult patients of different ages and sizes for plaque buildup and cardiovascular problems. Patient size matters because more x-rays are required to image a larger person. “A lot of imaging centers will use one setting for all patients,” says Chen. “You get beautiful image quality on everybody, but the downside is that some patients get more radiation than they probably should.” In his study, the system takes a quick preliminary scan that uses low-dose x-rays to figure out how big a patient is and how much radiation will be needed for the diagnostic image.

Most patients who got a scan in the new Toshiba machine received 0.93 millisieverts of radiation, and almost every patient received less than 4 millisieverts. Radiation exposure was decreased by as much as 95 percent relative to other CT scanners currently in use.

http://www.linkedin.com/profile/view?id=87597&trk=tab_pro

The reader is advised to review Alternative #3 in the following article, published on 3/10/2013, including the Editorial in NEJM by Dr. Redberg, UCSF, included in the article, prior to reading the content, below — as background on this important topic having the potential to change best practice and standard of care in the ER/ED.

Acute Chest Pain/ER Admission: Three Emerging Alternatives to Angiography and PCI – Corus CAD, hs cTn, CCTA

CCTA for Chest Pain Cuts Costs, Admissions

By Eric Barnes, AuntMinnie.com staff writer

May 14, 2013 — One of the largest studies yet comparing medical resource use and outcomes among chest pain patients found that coronary CT angiography (CCTA) reduced medical resource utilization compared to standard care, generating fewer hospital admissions and shorter emergency room stays, researchers reported in the Journal of the American College of Cardiology.

The retrospective study compared matched cohorts of nearly 1,000 patients presenting with chest pain before and after implementation of routine CCTA evaluation. The study team from Stony Brook, NY, and two other institutions found that patients receiving the standard workup for chest pain — which is to say, mostly observation — were admitted to the hospital almost five times as frequently as patients receiving CT. The standard workup patients also had significantly longer stays when admitted.

The rates of invasive angiography without revascularization and recidivism were also much higher for patients receiving standard care (JACC, May 14, 2013).

“I think the take-home message is that CT done correctly by experts with the resources to do it correctly on a routine basis is not only safe and feasible, but reduces healthcare resource utilization,” said lead author Dr. Michael Poon, from Stony Brook Medical Center, in an interview with AuntMinnie.com.

More than $10 billion in costs

Caring for chest pain is an expensive proposition in the U.S., costing upward of $10 billion a year for some 6 million emergency department (ED) visits. To reduce the problem of overcrowded emergency rooms, some hospitals have implemented chest pain evaluation units, but the care isn’t comprehensive or necessarily all that helpful, Poon said.

“It has been a problem and a major dilemma for emergency rooms because for most patients, it’s a false alarm,” he said. “I would say nine out of 10 are false alarms, but how to pick out that one is very tricky and costly. So what most hospitals tend to do is a one-size-fits-all policy where everybody gets blood tests and an electrocardiogram, and they keep patients in the ED for an extended period of time. So if you come in Friday, you may stay until Monday.”

Coronary CTA has been shown to be safe and cost-effective for acute chest pain evaluation in several smaller studies and in three smaller multicenter trials, but those studies have been limited by a lack of CT availability outside of weekdays and office hours, while EDs must operate 24/7, Poon said.

“All of those studies were done in a randomized, controlled fashion and in an artificial environment,” where each patient was randomized to either a stress test or CT during weekday office hours, Poon said. “But in real life, there is no such thing; it cannot be done.”

More often, chest pain patients get a couple of tests and several hours of observation before they are sent home.

Poon and colleagues from Stony Brook, William Beaumont Hospital, and the University of Toronto wanted to do a “real-world” observational study to show that CT remained cost-effective and efficient for triaging chest pain patients.

The study sought to compare the overall impact of CT on clinical outcomes and efficacy, when comparing CCTA and the hospital’s standard evaluation for the triage of chest pain patients, with CCTA available 12 hours a day, seven days a week.

From a total of 9,308 patients with a chest pain diagnosis upon admission, the study used a matched sample of 894 patients without a history of coronary artery disease and without positive troponin or ischemic changes on an electrocardiogram.

Patients undergoing CT were scanned on a 64-detector-row scanner (LightSpeed VCT, GE Healthcare) following administration of iodinated contrast and metoprolol as a beta-blocker for those with heart rates faster than 65 beats per minute (bpm).

Those with a body mass index (BMI) less than 30 were scanned at 100 kV, while those with a BMI between 30 and 50 were scanned at 120 kV. Retrospective gating was reserved for patients whose heart rates remained above 65 bpm. Obstructive stenosis was defined as 50% or greater lumen narrowing.

CT choice faster, more efficient

The results showed a lower overall admission rate of 14% for CCTA, compared with 40% for the standard of care (p < 0.001). In fact, patients undergoing standard evaluation were 5.5 times more likely to be admitted (p < 0.001) than CCTA patients.

The length of stay in the ED was 1.6 times longer for standard care (p < 0.001) than for CCTA. For patients undergoing CCTA, the median radiation dose was 5.88 mSv.

“We also showed that the recidivism rate is higher for standard of care, meaning that they come back within one month with recurrent chest pain,” Poon said. The odds of returning to the ED within 30 days were five times greater for patients in the standard evaluation group (odds ratio, 5.06; p = 0.022).

“In the era of Obamacare, this is a penalty to the hospital; you don’t want the patient returning within one month with the same diagnosis,” he said. When that happens, “you’re not only not getting paid, you have to pay a penalty. It’s a double whammy. We also show that downstream invasive coronary angiography is significantly less in the CCTA arm.”

More invasive angiography

Patients receiving standard care were seven times more likely to undergo invasive coronary angiography without revascularization (odds ratio, 7.17; p ≤ 0.001), while neither patient group was significantly more likely to undergo revascularization.

“Many physicians use [catheterization] as a way of getting patients in and out of the hospital,” Poon said. However, the cost is more than $10,000 per procedure.

The high rate of angiography without revascularization in the standard care group was not seen in the Rule Out Myocardial Infarction/Ischemia Using Computer Assisted Tomography (ROMICAT) I and II trials, where all patients in the standard care group underwent stress testing before angiography was considered, he said.

Poon credited the ROMICAT trials’ routine use of stress tests with diminishing CT’s relative advantage in resource use. “In the real world, that is not available,” he said. The present study, in which only about 20% of the standard care patients underwent stress tests, is more realistic.

Finally, Poon and colleagues showed no difference in rates of myocardial infarction between CT and the standard of care within the first 30 days of follow up. However, that is changing as patients are followed for longer time periods, he noted.

“We see a trend starting to diverge in our next report, which follows [patients] for six months,” he said. “You see a lot more acute myocardial infarction in the standard care arm, and we’re going to extend it for a year.”

The authors concluded that using CCTA to rule out acute coronary syndromes in low-risk chest pain patients is likely to improve doctors’ ability to triage patients with the common presentation of chest pain. The result of this approach appears to be fewer hospital admissions, shorter stays, less recidivism, less invasive angiography, and better patient outcomes.

In any case, Poon said, the study method is permanent at Stony Brook University, where the standard of care now incorporates CCTA.

“We didn’t stop doing it after the study,” he said. “If you look at some of the randomized, controlled studies, they actually went back to the standard of care.” They had to because those kinds of protocols are only practical with a grant.

Related Reading

CORE 320 study evaluates CCTA and SPECT for CAD diagnosis, March 25, 2013

Study affirms CCTA’s value to rule out myocardial infarction, March 19, 2013

CCTA predicts heart attack in people without risk factors, February 19, 2013

Study: Use CCTA 1st for lower-risk chest pain patients, February 4, 2013

2010 CCTA appropriateness criteria yield mixed results, January 31, 2013
Copyright © 2013 AuntMinnie.com

http://www.auntminnie.com/index.aspx?sec=sup&sub=cto&pag=dis&ItemID=103419&wf=5447

Other related articles on this Open Access Online Scientific Journal include the following:

Economic Toll of Heart Failure in the US: Forecasting the Impact of Heart Failure in the United States – A Policy Statement From the American Heart Association

Aviva Lev-Ari, PhD, RN, 4/25/2013

https://pharmaceuticalintelligence.com/2013/04/25/economic-toll-of-heart-failure-in-the-us-forecasting-the-impact-of-heart-failure-in-the-united-states-a-policy-statement-from-the-american-heart-association/

Diagnosis of Cardiovascular Disease, Treatment and Prevention: Current & Predicted Cost of Care and the Promise of Individualized Medicine Using Clinical Decision Support Systems

Larry H Bernstein, MD, FACP and Aviva Lev-Ari, PhD, RN, Curator, 5/15/2013

https://pharmaceuticalintelligence.com/2013/05/15/diagnosis-of-cardiovascular-disease-treatment-and-prevention-current-predicted-cost-of-care-and-the-promise-of-individualized-medicine-using-clinical-decision-support-systems-2/

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