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Tumor board Live… Molecular profiling great for identifying synthetic lethal combinations work very well… Many oncologist not accepting recommendations of molec tumor board

@AVIVA1950

@Pharma_BI

@AdvancingPM

Tumor board Live . Oncologists don’t always accept tumor board recommendations based on molecular profiling… Dr Baptiste at first felt constrained to use single agent but WINTER combo trial with molec profiling better

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Tumor board Live… Oncologist may give pushback when molecular therapeutic targets identified.. like when methylomics give a result and tumor board suggest temazolamide

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Tumor board Live… Oncologist may give pushback when molecular therapeutic targets identified.. like when methylomics give a result and tumor board suggest temazolamide

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@AVIVA1950

@AdvancingPM

Tumor board Live… Oncologist may give pushback when molecular therapeutic targets identified.. like when methylomics give a result and tumor board suggest temazolamide

@Pharma_BI

@AVIVA1950

@AdvancingPM

Pemetrexemed not always working but MTAP inhibitions may work

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@AVIVA1950

@AdvancingPM

Tumor board Live… Discussion of ovarian cancer case women first presented with CRC BRCA mut but failed PARP inhibitor board is looking at immunotherapy NGS IHC performed

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#WINconsortium

Fusions being detected by RNAseq at rate of 100 per month

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Tumor board Live…. Theranostics are becoming part of molec tumor board … Radio labeled dual diagnostic therapeutic antibodies

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Tumor board Live… Molecular profiling great for identifying synthetic lethal combinations work very well… Many oncologist not accepting recommendations of molec tumor board

@AVIVA1950

@Pharma_BI

@AdvancingPM

SESSION 2

Expanding the Precision Frontier

9:55-10:25

Precision Oncology in the Immunotherapy Era: Biomarkers and Clinical Trial Innovation

Lillian Siu, MD, President, AACR 2025-2026; Director, Phase I Clinical Trials Program; Co-Director, Robert and Maggie Bras and Family Drug Development Program Clinical Lead, Tumor Immunotherapy Program; BMO Chair, Precision Cancer Genomics, Princess Margaret Cancer Centre Professor of Medicine, University of Toronto

Princess Margaret CC went to Merck got pembrolizumab from them but built a team platform of clinicians and scientists to work on INSPIRE trial
$11 million of grants, 13 major papers, great team science
did ctDNA from liquid biopsy and also looked at methylation patterns in cfDNA
looked at IFN stimulation and outcome to pembrolizumab
retro transposable elements found in INSPIRE program, maybe a predictor of immune sensitivity
they were able to correlate some of their findings with spatial omics
using spatial data they could look at hot versus cold head and neck cancer
factors for response to immunotherapy: TMB, t cell infiltrate, PDL1 etc
using AI with IHC slides as well as NGS data sets
as clinical trials become multiomics and AI with multiomics platforms data sharing will be critical for success

10:25 – 10:35

The Microbiome and Its Role in Cancer Development and Treatment Response

Sabine Hazan, MD, CEO, Ventura Clinical Trials; CEO, Progenabiome

microbiome research at the infancy so we don’t know much when comes to oncology
we need to compare microbiome between persons using NGS and other omics
we all have different microbiome even though microbiome ‘healthy’
lots of factors affect microbiome including surgery
families are similar in their microbiome but when looking at Alzheimers there are differences
first lab to find whole COVID in the stools
virus was different in different people, difference spike proteins. Virus mutates from lung to stool (gut)
in intrafamily patients had different microbiome upon COVID infection
bifodobacteria was found as a major part of microbiome altered in COVID but also lots of other diseases
lots of examples of host microbial symbiosis
they had an instance with throat tumor treated with microbiome and tumor receded without chemo
in a glioblastoma microbiome adjustment helped but changed positive response to immunotherapy

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Real Time Coverage Morning Session on Precision Oncology: Advancing Precision Medicine Annual Conference, Philadelphia PA November 1 2024

Posted in Big Data, Biomarkers & Medical Diagnostics, Cancer Genomics, Childhood cancer, children, Circulating Tumor Cells (CTC), Clinical Genomics, CRISPR/Cas9 & Gene Editing, Diagnostics and Lab Tests, FDA, FDA Regulatory Affairs, Health Economics and Outcomes Research, Liquid Biopsy: Circulating Tumor Cells in Urine and Blood, Personalized and Precision Medicine & Genomic Research, Precision Cancer Medicine, REAL TIME Conference Coverage Twitter's Hashtags and Handles per Presentation/session, tagged Advancing Precision Medicine, ALS, ctDNA Liquid Biopsy, disease models, genetic diseases, genetic panels, health economics, health equity, Health insurance, liquid biopsy, Molecular Diagnostics, oncology, precision medicine, Rare diseases, Reimbursement for Molecular DIagnostics on November 1, 2024| 1 Comment »

Real Time Coverage Morning Session on Precision Oncology: Advancing Precision Medicine Annual Conference, Philadelphia PA November 1 2024

Reporter: Stephen J. Williams, Ph.D.

Notes from Precision Medicine for Rare Diseases 9:00AM – 10:50

Precision Medicine and markers Cure models vs disease models Dr Ekker from UT MD Anderson

UT MD Anderson zebrafish disease model program now focusing more on figuring the mechanisms by which a disease model is reverted to normal upon CRISPR screens
Traditional drug development process long and expensive
2nd in class only takes 4 years while 3rd in class drugs take only 1.5 years
Health-in-a-fish: using a CRE system to go from disease to normal
The theory is making a CRE or CURE avatar; taking a diseased zebrafish and reverse engineering the disease genome
He used transposon based CRE mutational mutants with protein trap and 3’ exon trap (transposon based mutagenesis)
He reverted the diseased gene by CRE
He feels that can scale up to using organoids to develop more cure based models

FDA Christine Nguyen MD regulatory perspective of framework of drug approval for rare diseases

1 in 10 Amercians have rare diseases; 70% genetic and half are children
Due to Orphan Drug Act in 2023 half of novel drugs approved for rare diseases
CDER and FDA 550 unique drugs for over 1000 rare diseases
Clinical and surrogate validated endpoints are important for traditional approvals
For accelerated approval need predictive surrogate endpoint of clinical benefit
For accelerated approval needs completion of a confirmatory trials so FDA has new authority under FDORA; FDA can dictate trial milestones
Candidate surrogate endpoints: known to predict (validated) for traditional approval but reasonably likely to predict for accelerated approval
Does surrogate endpoint associated with a causal pathway? Also important to understand the magnitude of benefit so surrogate should be quantitative not just qualitative
RDEA is a series of 3 public workshops at FY2027 to promote innovation and novel endpoints and guidance

Frank Sasinowski FDA regulatory flexibility beyond One Positive Adequate and Well Controlled Trial

As we move to rare diseases we may only have one well controlled study so FDA feels we need new regulatory frameworks and guidelines especially for rare disease clinical trails especially with precision medicine
Accelerated approval does not mean your evidence is any less stringent that traditional approval (only difference is endpoint but quality of evidence the same)

Confirmatory evidence is a primary concern
In 2021 FDA coordinated with the two divisions CBER and CDER
Sometimes a primary endpoint shows positive benefit but secondary endpoints may not; FDA now feels that results from one well designed AWC gives confirmatory evidence
FDA can be flexible by taking in consideration the quantity and quality of confirmatory evidence and the totality of evidence
So pharmacology studies, natural history etc. can be enough
For a drug like Lamzede for mannosidosis there were no positive endpoint studies or for ADA SCID disease there was other compelling evidence
The FDA does have flexibility when it comes to advanced precision medicines and ultr rare diseases

10:50 Do we Really Need Liquid Biopsy? A Panel Discussion on the Issues Hampering the full Adoption of Liquid Biopsy

In Mexico leading cancer is colorectal but only have the FIT test and noone except one organization who issupplying health access
Access to precision medicine is a concern: the communication between the patient, who is pushing this more than healthcare, needs to be coordinated better with all stakeholders in care
We also need to educate many physicians even oncologists (like in Virginia) a better understanding of genetics and omics
FT3 consortium does testing to therapy (multistakeholder group comprised of patient advocacy groups); focus on amplifying global efforts to increase access; they are trying to make a roadmap to help access in other countries; when it comes to precision medicine it is usually the nurses that are aksing for training because they are usually the first responders for the patient’s questions
In rural areas just getting access to liquid biopsy is a concern and maybe satellite sites might be useful because the time to schedule is getting worse (like 3 or more months)
A recent paper showed that liquid biopsy may actually perpetuate health disparities and not ameliorate them
BloodPAC: there are barriers to LB access and adoption so consortium felt that there were many areas that need to be addressed: financial, access, disparities, education
ctDNA to define variants was the past focus; there is growing realization that there are representatives populations in your R&D studies
Submission of data to BloodPac is easier to do for tissue not for liquid biopsy; there is lack of harmonization across many of these databanks
Reimbursement: is a barrier to access for liquid biopsy
Illumina: challenge finding clinical utility for payers; FDA approval is not as hard; show improved outcomes for patients; Medicare is starting to approve some tests but the criteria bar keeps changing with payers;
How do we leverage the on-market data to support performance of your diagnostic test or genomic panel

This event will be covered by the LPBI Group on Twitter. Follow on

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Live Notes, Real Time Conference Coverage 2020 AACR Virtual Meeting April 28, 2020 Session on Early Detection and ctDNA 1:35 – 3:55 PM

Posted in BioBanking, BioIT: BioInformatics, BioIT: BioInformatics, NGS, Clinical & Translational, Pharmaceutical R&D Informatics, Clinical Genomics, Cancer Informatics, Breast Cancer - impalpable breast lesions, Cancer - General, Cancer and Current Therapeutics, CANCER BIOLOGY & Innovations in Cancer Therapy, Cancer Genomics, Circulating Tumor Cells (CTC), Computational Biology/Systems and Bioinformatics, interventional oncology, Liquid Biopsy Chip detects an array of metastatic cancer cell markers in blood, Scientific & Biotech Conferences: Press Coverage, tagged AACR, American Association for Cancer Research, breast cancer screening, Cancer screening, Clinical trial, Conference Coverage with Social Media, ctDNA, ctDNA Liquid Biopsy, liquid biopsy, real time conference coverage, TRACERx on April 28, 2020| Leave a Comment »

Live Notes, Real Time Conference Coverage 2020 AACR Virtual Meeting April 28, 2020 Session on Early Detection and ctDNA 1:35 – 3:55 PM

Reporter: Stephen J. Williams, PhD

Introduction
Alberto Bardelli

circulating tumor DNA has been around but with NGS now we can have more specificity in analyzing ctDNA
interest lately in using liquid biopsy to gain insight on tumor heterogeneity versus single needle biopsy of the solid tumor
these talks will however be on ctDNA as a diagnostic and therapeutic monitoring modality

Prediction of cancer and tissue of origin in individuals with suspicion of cancer using a cell-free DNA multi-cancer early detection test
David Thiel

@MayoClinic

test has a specificity over 90% and intended to used along with guideline
The Circulating Cell-free Genome Atlas Study (clinical trial NCT02889978) (CCGA) study divided into three substudies: highest performing assay, refining assay, validation of assays
methylation based assays worked better than sequencing (bisulfite sequencing)
used a machine learning algorithm to help refine assay
prediction was >90%; subgroup for high clinical suspicion of cancer
HCS sensitivity was 100% and specificity very high; but sensitivity on training set was 40% and results may have been confounded by including kidney cancer
TOO tissue of origin was predicted in greater than 99% in both training and validation sets

A first-of-its-kind prospective study of a multi-cancer blood test to screen and manage 10,000 women with no history of cancer

DETECT-A study: prospective interventional study; can multi blood test be used prospectively and can lead to a personalized care; can the screen be used to complement current therapy?
10,000 women aged 65-75; these women could not have previous cancer and conducted through Geisinger Health Network; multi test detects DNA and protein and standard of care screening
the study focused on safety so a committee was consulted on each case, and used a diagnostic PET-CT
blood test alone not good but combined with protein and CT scans much higher (5 fold increase) detection for breast cancer

Nickolas Papadopoulos

@HopkinsMedicine

Discussant
David Huntsman

there are mutiple opportunities yet at same time there are still challenges to utilize these cell free tests in therapeutic monitoring, diagnostic, and screening however sensitivities for some cancers are still too low to use in large scale screening however can supplement current screening guidelines
we have to ask about false positive rate and need to concentrate on prospective studies
we must consider how tests will be used, population health studies will need to show improved survival

Phylogenetic tracking and minimal residual disease detection using ctDNA in early-stage NSCLC: A lung TRACERx study
Chris Abbosh @ucl

TRACERx study in collaboration with Charles Swanton.
multiplex PCR to track 200 SNVs: correlate tumor tissue biopsy with ctDNA
spike in assay shows very good sensitivity and specificity for SNVs variants tracked, did over 400 TRACERx libraries
sensitivity increases when tracking more variants but specificity does go down a bit
tracking variants can show evidence of subclonal dynamics and evolution and copy number deletion events; they also show neoantigen editing or changing of their neoantigens
this assay can detect low variants in a reproducible manner

The TRACERx (TRAcking Cancer Evolution through therapy (Rx)) lung study is a multi-million pound research project taking place over nine years, which will transform our understanding of non-small cell lung cancer (NSCLC) and take a practical step towards an era of precision medicine. The study will uncover mechanisms of cancer evolution by analysing the intratumour heterogeneity in lung tumours from approximately 850 patients and tracking its evolutionary trajectory from diagnosis through to relapse. At £14 million, it’s the biggest single investment in lung cancer research by Cancer Research UK, and the start of a strategic UK-wide focus on the disease, aimed at making real progress for patients.

Led by Professor Charles Swanton at UCL, the study will bring together a network of experts from different disciplines to help integrate clinical and genomic data and identify patients who could benefit from trials of new, targeted treatments. In addition, it will use a whole suite of cutting edge analytical techniques on these patients’ tumour samples, giving unprecedented insight into the genomic landscape of primary and metastatic tumours and the impact of treatment upon this landscape.

In future, TRACERx will enable us to define how intratumour heterogeneity impacts upon cancer immunity throughout tumour evolution and therapy. Such studies will help define how the clinical evaluation of intratumour heterogeneity can inform patient stratification and the development of combinatorial therapies incorporating conventional, targeted and immune based therapeutics.

Intratumour heterogeneity is increasingly recognised as a major hurdle to achieve improvements in therapeutic outcome and biomarker validation. Intratumour genetic diversity provides a substrate for tumour adaptation and evolution. However, the evolutionary genomic landscape of non-small cell lung cancer (NSCLC) and how it changes through the disease course has not been studied in detail. TRACERx is a prospective observational study with the following objectives:

Primary Objectives

Define the relationship between intratumour heterogeneity and clinical outcome following surgery and adjuvant therapy (including relationships between intratumour heterogeneity and clinical disease stage and histological subtypes of NSCLC).
Establish the impact of adjuvant platinum-containing regimens upon intratumour heterogeneity in relapsed disease compared to primary resected tumour.

Key Secondary Objectives

Develop and validate an intratumour heterogeneity (ITH) ratio index as a prognostic and predictive biomarker in relation to disease-free survival and overall survival.
Infer a complete picture of NSCLC evolutionary dynamics – define drivers of genomic instability, metastatic progression and drug resistance by identifying and tracking the dynamics of somatic mutational heterogeneity, and chromosomal structural and numerical instability present in the primary tumour and at metastatic sites. Individual tumour phylogenetic tree analysis will:
- Establish the order of somatic events in relation to genomic instability onset and metastatic progression
- Decipher genetic “bottlenecking” events following metastasis and drug therapy
- Establish dynamics of tumour evolution during the disease course from early to late stage NSCLC.
Initiate a longitudinal biobank of circulating tumour cells (CTCs) and circulating-free tumour DNA (cfDNA) to develop analytical methods for the early detection and monitoring of tumour evolution over time.
Develop a longitudinal tissue resource to serve as a platform to assess the relationship between genetic intratumour heterogeneity and the host immune response.
Define relationships between intratumour heterogeneity and targeted/cytotoxic therapeutic outcome.
Use a lung cancer specific gene panel in a certified Good Clinical Practice (GCP) laboratory environment to define clonally dominant disease drivers to address the role of clonal driver dominance in targeted therapeutic response and to guide stratification of lung cancer treatment and future clinical study inclusion (paired primary-metastatic site comparisons in at least 270 patients with relapsed disease).

Utility of longitudinal circulating tumor DNA (ctDNA) modeling to predict RECIST-defined progression in first-line patients with epidermal growth factor receptor mutation-positive (EGFRm) advanced non-small cell lung cancer (NSCLC)
Martin Johnson

Impact of the EML4-ALK fusion variant on the efficacy of lorlatinib in patients (pts) with ALK-positive advanced non-small cell lung cancer (NSCLC)
Todd Bauer

From an interview with Dr. Bauer at https://www.lungcancernews.org/2019/08/14/making-headway-with-lorlatinib/

Lorlatinib, a smallmolecule inhibitor of ALK and ROS1, was granted accelerated U.S. Food and Drug Administration approval in November 2018 for patients with ALK-positive metastatic NSCLC whose disease has progressed on crizotinib and at least one other ALK inhibitor or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. Todd M. Bauer, MD, a medical oncologist and senior investigator at Sarah Cannon Research Institute/Tennessee Oncology, PLLC, in Nashville, has been very involved with the development of lorlatinib since the beginning. In the following interview, Dr. Bauer discusses some of lorlatinib’s unique toxicities, as well as his first-hand experiences with the drug.

For further reading: Solomon B, Besse B, Bauer T, et al. Lorlatinib in Patients with ALK-positive non-small-cell lung cancer: results from a global phase 2 study. Lancet. 2018;19(12):P1654-1667.

Abstract

BACKGROUND: Lorlatinib is a potent, brain-penetrant, third-generation inhibitor of ALK and ROS1 tyrosine kinases with broad coverage of ALK mutations. In a phase 1 study, activity was seen in patients with ALK-positive non-small-cell lung cancer, most of whom had CNS metastases and progression after ALK-directed therapy. We aimed to analyse the overall and intracranial antitumour activity of lorlatinib in patients with ALK-positive, advanced non-small-cell lung cancer.

METHODS: In this phase 2 study, patients with histologically or cytologically ALK-positive or ROS1-positive, advanced, non-small-cell lung cancer, with or without CNS metastases, with an Eastern Cooperative Oncology Group performance status of 0, 1, or 2, and adequate end-organ function were eligible. Patients were enrolled into six different expansion cohorts (EXP1-6) on the basis of ALK and ROS1 status and previous therapy, and were given lorlatinib 100 mg orally once daily continuously in 21-day cycles. The primary endpoint was overall and intracranial tumour response by independent central review, assessed in pooled subgroups of ALK-positive patients. Analyses of activity and safety were based on the safety analysis set (ie, all patients who received at least one dose of lorlatinib) as assessed by independent central review. Patients with measurable CNS metastases at baseline by independent central review were included in the intracranial activity analyses. In this report, we present lorlatinib activity data for the ALK-positive patients (EXP1-5 only), and safety data for all treated patients (EXP1-6). This study is ongoing and is registered with ClinicalTrials.gov, number NCT01970865.

FINDINGS: Between Sept 15, 2015, and Oct 3, 2016, 276 patients were enrolled: 30 who were ALK positive and treatment naive (EXP1); 59 who were ALK positive and received previous crizotinib without (n=27; EXP2) or with (n=32; EXP3A) previous chemotherapy; 28 who were ALK positive and received one previous non-crizotinib ALK tyrosine kinase inhibitor, with or without chemotherapy (EXP3B); 112 who were ALK positive with two (n=66; EXP4) or three (n=46; EXP5) previous ALK tyrosine kinase inhibitors with or without chemotherapy; and 47 who were ROS1 positive with any previous treatment (EXP6). One patient in EXP4 died before receiving lorlatinib and was excluded from the safety analysis set. In treatment-naive patients (EXP1), an objective response was achieved in 27 (90·0%; 95% CI 73·5-97·9) of 30 patients. Three patients in EXP1 had measurable baseline CNS lesions per independent central review, and objective intracranial responses were observed in two (66·7%; 95% CI 9·4-99·2). In ALK-positive patients with at least one previous ALK tyrosine kinase inhibitor (EXP2-5), objective responses were achieved in 93 (47·0%; 39·9-54·2) of 198 patients and objective intracranial response in those with measurable baseline CNS lesions in 51 (63·0%; 51·5-73·4) of 81 patients. Objective response was achieved in 41 (69·5%; 95% CI 56·1-80·8) of 59 patients who had only received previous crizotinib (EXP2-3A), nine (32·1%; 15·9-52·4) of 28 patients with one previous non-crizotinib ALK tyrosine kinase inhibitor (EXP3B), and 43 (38·7%; 29·6-48·5) of 111 patients with two or more previous ALK tyrosine kinase inhibitors (EXP4-5). Objective intracranial response was achieved in 20 (87·0%; 95% CI 66·4-97·2) of 23 patients with measurable baseline CNS lesions in EXP2-3A, five (55·6%; 21·2-86·3) of nine patients in EXP3B, and 26 (53·1%; 38·3-67·5) of 49 patients in EXP4-5. The most common treatment-related adverse events across all patients were hypercholesterolaemia (224 [81%] of 275 patients overall and 43 [16%] grade 3-4) and hypertriglyceridaemia (166 [60%] overall and 43 [16%] grade 3-4). Serious treatment-related adverse events occurred in 19 (7%) of 275 patients and seven patients (3%) permanently discontinued treatment because of treatment-related adverse events. No treatment-related deaths were reported.

INTERPRETATION: Consistent with its broad ALK mutational coverage and CNS penetration, lorlatinib showed substantial overall and intracranial activity both in treatment-naive patients with ALK-positive non-small-cell lung cancer, and in those who had progressed on crizotinib, second-generation ALK tyrosine kinase inhibitors, or after up to three previous ALK tyrosine kinase inhibitors. Thus, lorlatinib could represent an effective treatment option for patients with ALK-positive non-small-cell lung cancer in first-line or subsequent therapy.

loratinib could be used for crizotanib resistant tumors based on EML4-ALK variants present in ctDNA

Reference:
1. Updated efficacy and safety data from the global phase III ALEX study of alectinib (ALC) vs crizotinib (CZ) in untreated advanced ALK+ NSCLC. J Clin Oncol 36, 2018 (suppl; abstr 9043).

Discussion

Corey Langer

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

Posted in Big Data & Analytics, BioBanking, CANCER BIOLOGY & Innovations in Cancer Therapy, Cancer Screening, Circulating Tumor Cells (CTC), Clinical Genomics, Diagnostics and Lab Tests, FDA, Health Economics and Outcomes Research, Healthcare costs and reimbursement, KRAS Mutation, Liquid Biopsy Chip detects an array of metastatic cancer cell markers in blood, Liquid Biopsy: Circulating Tumor Cells in Urine and Blood, Patient-centered Medicine, Personalized and Precision Medicine & Genomic Research, Scientific & Biotech Conferences: Press Coverage, Uncategorized, tagged biomarker panels, circulating cancer cells, circulating DNA, ctDNA Liquid Biopsy, healthcare reimbursement, liquid biopsy, therapeutic monitoring on July 12, 2018| Leave a Comment »

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

Reporter: Stephen J. Williams, PhD

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

Posted in CANCER BIOLOGY & Innovations in Cancer Therapy, Genome Biology, Liquid Biopsy: Circulating Tumor Cells in Urine and Blood, tagged assay sensitivity, ctDNA Liquid Biopsy, for ctDNA KRAS, KRAS as an improved diagnostic tool, KRAS mutant copy load, KRAS mutation as biomarker for metastatic disease, metastatic disease, prognosis and monitoring for therapeutic response, unresectable pancreatic cancer on July 6, 2016| Leave a Comment »

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/

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Posts Tagged ‘ctDNA Liquid Biopsy’

Real Time Conference Coverage: Advancing Precision Medicine Conference, Early Morning Session Track 1 October 4 2025

Real Time Conference Coverage: Advancing Precision Medicine Conference, Early Morning Session Track 1 October 4 2025

SESSION 1

Precision For All:

Global Access, Real Cases, and Implementation Science

SESSION 2

Expanding the Precision Frontier

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Real Time Coverage Morning Session on Precision Oncology: Advancing Precision Medicine Annual Conference, Philadelphia PA November 1 2024

Real Time Coverage Morning Session on Precision Oncology: Advancing Precision Medicine Annual Conference, Philadelphia PA November 1 2024

Notes from Precision Medicine for Rare Diseases 9:00AM – 10:50

10:50 Do we Really Need Liquid Biopsy? A Panel Discussion on the Issues Hampering the full Adoption of Liquid Biopsy

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

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

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

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

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

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

About Pancreatic Cancer and KRAS Mutations

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Posts Tagged ‘ctDNA Liquid Biopsy’

Real Time Conference Coverage: Advancing Precision Medicine Conference, Early Morning Session Track 1 October 4 2025

Real Time Conference Coverage: Advancing Precision Medicine Conference, Early Morning Session Track 1 October 4 2025

SESSION 1

Precision For All:

Global Access, Real Cases, and Implementation Science

SESSION 2

Expanding the Precision Frontier

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Real Time Coverage Morning Session on Precision Oncology: Advancing Precision Medicine Annual Conference, Philadelphia PA November 1 2024

Real Time Coverage Morning Session on Precision Oncology: Advancing Precision Medicine Annual Conference, Philadelphia PA November 1 2024

Notes from Precision Medicine for Rare Diseases 9:00AM – 10:50

10:50 Do we Really Need Liquid Biopsy? A Panel Discussion on the Issues Hampering the full Adoption of Liquid Biopsy

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Live Notes, Real Time Conference Coverage 2020 AACR Virtual Meeting April 28, 2020 Session on Early Detection and ctDNA 1:35 – 3:55 PM

Live Notes, Real Time Conference Coverage 2020 AACR Virtual Meeting April 28, 2020 Session on Early Detection and ctDNA 1:35 – 3:55 PM

Primary Objectives

Key Secondary Objectives

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

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

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Like this:

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

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

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

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

About Pancreatic Cancer and KRAS Mutations

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

Share this:

Like this:

Follow Blog via Email

Recent Posts

Archives

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Meta