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Posts Tagged ‘ctDNA Liquid Biopsy’


Live Conference Coverage @Medcitynews Converge 2018 Philadelphia:Liquid Biopsy and Gene Testing vs Reimbursement Hurdles

9:25- 10:15 Liquid Biopsy and Gene Testing vs. Reimbursement Hurdles

Genetic testing, whether broad-scale or single gene-testing, is being ordered by an increasing number of oncologists, but in many cases, patients are left to pay for these expensive tests themselves. How can this dynamic be shifted? What can be learned from the success stories?

Moderator: Shoshannah Roth, Assistant Director of Health Technology Assessment and Information Services , ECRI Institute @Ecri_Institute
Speakers:
Rob Dumanois, Manager – reimbursement strategy, Thermo Fisher Scientific
Eugean Jiwanmall, Senior Research Analyst for Medical Policy & Technology Evaluation , Independence Blue Cross @IBX
Michael Nall, President and Chief Executive Officer, Biocept

 

Michael: Wide range of liquid biopsy services out there.  There are screening companies however they are young and need lots of data to develop pan diagnostic test.  Most of liquid biopsy is more for predictive analysis… especially therapeutic monitoring.  Sometimes solid biopsies are impossible , limited, or not always reliable due to metastasis or tough to biopsy tissues like lung.

Eugean:  Circulating tumor cells and ctDNA is the only FDA approved liquid biopsies.  However you choose then to evaluate the liquid biopsy, PCR NGS, FISH etc, helps determines what the reimbursement options are available.

Rob:  Adoption of reimbursement for liquid biopsy is moving faster in Europe than the US.  It is possible in US that there may be changes to the payment in one to two years though.

Michael:  China is adopting liquid biopsy rapidly.  Patients are demanding this in China.

Reimbursement

Eugean:  For IBX to make better decisions we need more clinical trials to correlate with treatment outcome.  Most of the major cancer networks, like NCCN, ASCO, CAP, just have recommendations and not approved guidelines at this point.  From his perspective with lung cancer NCCN just makes a suggestion with EGFR mutations however only the companion diagnostic is approved by FDA.

Michael:  Fine needle biopsies are usually needed by the pathologist anyway before they go to liquid biopsy as need to know the underlying mutations in the original tumor, it just is how it is done in most cancer centers.

Eugean:  Whatever the established way of doing things, you have to outperform the clinical results of the old method for adoption of a newer method.

Reimbursement issues have driven a need for more research into clinical validity and utility of predictive and therapeutic markers with regard to liquid biopsies.  However although many academic centers try to partner with Biocept Biocept has a limit of funds and must concentrate only on a few trials.  The different payers use different evidence based methods to evaluate liquid biopsy markers.  ECRI also has a database for LB markers using an evidence based criteria.  IBX does sees consistency among payers as far as decision and policy.

NGS in liquid biopsy

Rob: There is a path to coverage, especially through the FDA.  If you have a FDA cleared NGS test, it will be covered.  These are long and difficult paths to reimbursement for NGS but it is feasible. Medicare line of IBX covers this testing, however on the commercial side they can’t cover this.  @IBX: for colon only kras or nras has clinical utility and only a handful of other cancer related genes for other cancers.  For a companion diagnostic built into that Dx do the other markers in the panel cost too much?

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Trovagene’s ctDNA Liquid Biopsy urine and blood tests to be used in Monitoring and Early Detection of Pancreatic Cancer

Reporters: David Orchard-Webb, PhD and Aviva Lev-Ari, PhD, RN

UPDATED on 7/29/2016

Trovagene’s Dual-Sample Liquid Biopsy Performs Well in First Peer-Reviewed Study

https://www.genomeweb.com/trovagenes-dual-sample-liquid-biopsy-performs-well-first-peer-reviewed-study?utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Daily%20News:%20NIH%20Seeks%20New%20Centers%20for%20Precision%20Medicine%20Initiative%20Participant%20Enrollment,%20Management%20-%2007/29/2016%2004:15:00%20PM

Detection and quantitation of ctDNA KRAS mutations from patients with unresectable pancreatic cancer

Inna Chen 1 , Victoria M. Raymond 2 , Jennifer Geis 2 , Sandeep Pingle 2 , Fernando F. Blanco 2 Eric A. Collisson 3 , Vlada Melnikova 2 , Margaret Tempero 3 , Mark G. Erlander 2 , and Julia S. Johansen 1 1Department of Oncology, Herlev and Gentofte Hospital, University of Copenhagen, Denmark; 2Trovagene, Inc, San Diego, California, USA; 3Department of Oncology, University of California San Francisco, California, USA

Conclusions

• This is the largest, prospective dataset exploring ctDNA KRAS in unresectable pancreatic cancer.

• 92.9% of 210 patients with unresectable pancreatic cancer were positive for ctDNA KRAS.

• This detection rate closely matches the published prevalence of KRAS in pancreatic cancer (90%), and out performs previous studies, demonstrating the superior assay sensitivity.

• ctDNA analysis offers a viable tissue biopsy alternative for determining KRAS mutation status, especially in late stage patients.

• ctDNA KRAS analysis identified 52% more patients as positive than CA19-9, demonstrating KRAS as an improved diagnostic tool.

• Individuals with metastatic disease had a 8.2 fold difference in median ctDNA KRAS mutation load at baseline versus a 3.9 fold difference in baseline CA19-9. KRAS may represent an improved biomarker for metastatic disease over CA19-9.

• In two representative patients, dynamic changes in KRAS mutation load were consistent with response by imaging and predicted progressive disease months in advance of progression by imaging.

• Quantitation of KRAS mutant copy load may provide a more informative biomarker for prognosis and monitoring for therapeutic response

http://www.trovagene.com/wp-content/uploads/Posters/20160512%20AACR%20PancreasPoster(1).pdf

 

Trovagene and University of Michigan Enter into Collaboration for Monitoring and Early Detection of Pancreatic Cancer

Trovagene’s KRAS ctDNA liquid biopsy test will be at the forefront of research partnership with Dr. Diane Simeone at University of Michigan Health System

SAN DIEGO, July 6, 2016 /PRNewswire/ — Trovagene, Inc. (NASDAQ: TROV), a developer of circulating tumor DNA (ctDNA) molecular diagnostics, today announced the initiation of a multi-phased collaborative research program with the University of Michigan Comprehensive Cancer Center utilizing the Trovera™ KRAS ctDNA liquid biopsy test.

 

About Pancreatic Cancer and KRAS Mutations

The relative 1-year survival rate for patients with pancreatic cancer is only 28%, and the overall 5-year survival rate is 8%; stage IV pancreatic cancer has a 5-year survival rate of about 1%. At present, surgery offers the only therapeutic means of cure, but less than 20% of patients present with tumors amenable to resection.

The significant mortality rate of pancreatic cancer is due to the high incidence of metastases at the time of diagnosis, its fulminant clinical course, and the lack of adequate systemic therapies. Patients who undergo resection for localized pancreatic carcinoma have a long-term survival of approximately 20% and a median survival of 13 to 20 months. At the other end of the clinical spectrum, a high percentage (40% to 45%) of patients present with unresectable metastatic disease, with a short survival of only 3 to 6 months.

Mutations of the KRAS gene occurs in over 90% of pancreatic carcinomas – no other human tumor comes close in mutational frequency of this particular gene.

SOURCE

http://www.prnewswire.com/news-releases/trovagene-and-university-of-michigan-enter-into-collaboration-for-monitoring-and-early-detection-of-pancreatic-cancer-300294646.html?tc=portal_CAP

http://www.trovagene.com/

 

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

 

 

Hyaluronidase treatment of high HA pancreatic cancer increased progression-free survival

Author: David Orchard-Webb, PhD

https://pharmaceuticalintelligence.com/2016/07/03/hyaluronidase-treatment-of-high-ha-pancreatic-cancer-increased-progression-free-survival/

 

Targeting paclitaxel to the pancreas with a biodegradable drug-eluting device

Author: David Orchard-Webb, PhD

https://pharmaceuticalintelligence.com/2016/07/03/targeting-paclitaxel-to-the-pancreas-with-a-biodegradable-drug-eluting-device/

 

Recent Research On SMAD4 In Pancreatic Cancer

Curator: David Orchard-Webb, PhD

https://pharmaceuticalintelligence.com/2016/06/27/recent-research-on-smad4-in-pancreatic-cancer/

 

Pancreatic Cancer Modeling using Retrograde Viral Vector Delivery and IN-Vivo CRISPR/Cas9-mediated Somatic Genome Editing

Curators: Larry H. Benstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/06/10/pancreatic-cancer-modeling-using-retrograde-viral-vector-delivery-and-in-vivo-crisprcas9-mediated-somatic-genome-editing/

 

Mutations in RAS genes

Curator: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2016/04/23/mutations-in-ras-genes/

 

TP53 tumor Drug Resistance Gene Target

Curator: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2015/12/27/p53-tumor-drug-resistance-mechanism-target/

 

Pancreatic Cancer Targeted Treatment?

Curator: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2016/05/18/pancreatic-cancer-targeted-treatment/

 

Aduro Biotech Phase II Pancreatic Cancer Trial CRS-207 plus cancer vaccine GVAX Fails

Reporter: Stephen J Williams, PhD

https://pharmaceuticalintelligence.com/2016/05/16/aduro-biotech-phase-ii-pancreatic-cancer-trial-crs-207-plus-cancer-vaccine-gvax-fails/

 

The “Guardian Of The Genome” p53 In Pancreatic Cancer

Curator: David Orchard-Webb, PhD

https://pharmaceuticalintelligence.com/2016/05/09/the-guardian-of-the-genome-p53-in-pancreatic-cancer/

 

Targeting Epithelial To Mesenchymal Transition (EMT) As A Therapy Strategy For Pancreatic Cancer

Curator: David Orchard-Webb, PhD

https://pharmaceuticalintelligence.com/2016/04/19/targeting-emt-as-a-therapy-strategy-for-pancreatic-cancer/

 

Pancreatic Cancer at the Crossroads of Metabolism

Curator: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2015/10/13/pancreatic-cancer-at-the-crosroad-of-metabolism/

 

Using CRISPR to investigate pancreatic cancer

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/07/31/using-crispr-to-investigate-pancreatic-cancer/

 

Prostate Cancer Cells: Histone Deacetylase Inhibitors Induce Epithelial-to-Mesenchymal Transition

Reporter-Curator: Stephen J. Williams, PhD

https://pharmaceuticalintelligence.com/2012/11/30/histone-deacetylase-inhibitors-induce-epithelial-to-mesenchymal-transition-in-prostate-cancer-cells/

 

@Mayo Clinic: Inhibiting the gene, protein kinase D1 (PKD1), and its protein could stop spread of this form of Pancreatic Cancer

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/02/24/inhibiting-the-gene-protein-kinase-d1-pkd1-and-its-protein-could-stop-spread-of-this-form-of-pancreatic-cancer/

 

Locally Advanced Pancreatic Cancer: Efficacy of FOLFIRINOX

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/06/01/locally-advanced-pancreatic-cancer-efficacy-of-folfirinox/

 

Consortium of European Research Institutions and Private Partners will develop a microfluidics-based lab-on-a-chip device to identify Pancreatic Cancer Circulating Tumor Cells (CTC) in blood

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2014/04/10/consortium-of-european-research-institutions-and-private-partners-will-develop-a-microfluidics-based-lab-on-a-chip-device-to-identify-pancreatic-cancer-circulating-tumor-cells-ctc-in-blood/

 

What`s new in pancreatic cancer research and treatment?

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/10/21/whats-new-in-pancreatic-cancer-research-and-treatment/

 

Pancreatic Cancer: Genetics, Genomics and Immunotherapy

Author: Tilda Barliya, PhD

https://pharmaceuticalintelligence.com/2013/04/11/update-on-pancreatic-cancer/

 

Targeting the Wnt Pathway

Writer and Curator: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2015/04/10/targeting-the-wnt-pathway-7-11/

 

Gene Amplification and Activation of the Hedgehog Pathway

Curator: Larry H Bernstein, MD, FCAP

https://pharmaceuticalintelligence.com/2015/10/29/gene-amplification-and-activation-of-the-hedgehog-pathway/

 

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