Highlights & Summary

Liquid Biopsy (LBx) continued to develop through October, featuring new approvals, coverage, and collaborations.

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Clinical & Regulatory

The FDA approved Foundation Medicine's genomic tests, FoundationOne®CDx and FoundationOne®Liquid CDx, as companion diagnostics for Pfizer’s BRAFTOVI® and MEKTOVI® to identify metastatic non-small cell lung cancer patients with a BRAF V600E mutation, potentially benefiting from this treatment combination​. The Avantect™ Pancreatic Cancer Test by ClearNote Health™ has received a new Current Procedural Terminology (CPT) code, 0410U, from the American Medical Association, effective October 1, 2023, establishing a reimbursement pathway for broader patient access. Additionally, a preliminary reimbursement rate of $1,160 has been proposed by the Centers for Medicare and Medicaid Services, with final rates expected to be effective on January 1, 2024​​.

1 | FDA Approves Foundation Medicine CDx Tests for Pfizer’s BRAFTOVI-MEKTOVI® combo to Identify Patients with BRAF V600E Alterations in Metastatic NSCLC FDA Approval | Foundation Medicine, Pfizer

2 | Avantect Pancreatic Cancer Test Receives CPT Code and Preliminary Payment Determination from the Centers for Medicare and Medicaid Services PLA Code Announcement | ClearNote Health‍

Company Announcements & Product Launches

Foundation Medicine and Natera have launched FoundationOne®Tracker, a ctDNA test to monitor cancer therapy response, now available to all U.S. healthcare providers and covered by Medicare for monitoring response to immune-checkpoint inhibitor therapy in certain beneficiaries from June 17, 2023. QIAGEN and Myriad Genetics have formed a partnership to develop companion diagnostic tests for cancer, aiming to provide innovative solutions to pharmaceutical companies for the U.S. and global markets. The collaboration will leverage QIAGEN's PCR and next-generation sequencing technologies, and Myriad's assay development expertise, initially focusing on developing assays using these technologies, with plans to explore advanced detection of measurable residual disease (MRD) and homologous recombination deficiency (HRD) in future projects. Precede Biosciences revealed pivotal data from its novel liquid biopsy platform at the ESMO 2023 congress and in Nature Medicine, demonstrating its potential to significantly influence therapeutic and clinical decisions. The data, stemming from a collaboration with Dana-Farber Cancer Institute, comprised over 1,200 cell-free-DNA transcriptional profiles from more than 400 patients across 15 different cancer types, marking it as the largest dataset of its kind, according to the company. 

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1 | Foundation Medicine and Natera Launch ctDNA Therapy Response Assay With Medicare Coverage Product Launch | Foundation Medicine, Natera

2 | QIAGEN and Myriad Genetics partner to advance companion diagnostics development for cancer CDx Partnership Announcement | Qiagen, Myriad Genetics

3 | Precede Biosciences Debuts Chromatin-Based Liquid Biopsy Platform Backed by New Data at ESMO Clinical Data Results | Precede Biosciences, Dana-Farber Cancer Institute

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Additional Sources

1 | Foundation Medicine Expands Partnership with Sequanta to Provide both Liquid and Tissue Genomic Profiling Services in China to Support Global Regulatory Filings Global Partnership Announcement | Foundation Medicine, Sequanta

2 | Foundation Medicine to Participate in NCI Initiative to Test New Cancer Combination Therapies Participation in Clinical Trial | Foundation Medicine

3 | Startup Vesica Health to Revive MDxHealth Bladder Cancer Assay Boosted by New Clinical Impact Data Product Launch | Vesica Health

4 | BioCaptiva Partners With UHI, NHS Highland to Evaluate cfDNA Device for Pleural Disease Dx New Study | BioCaptiva, UHI, NHS Highland

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Clinical Trials & Study Results

The PATHFINDER study by GRAIL demonstrated the ability of its multi-cancer early detection (MCED) blood test to identify various cancer types, substantially increasing the number of detected cancers when added to standard screening. The study, encompassing 6,662 adults, enabled rapid diagnostic resolution, with nearly half of the detected cancers identified at an early, potentially more treatable stage. Analysis from new TRACERx data shows Personalis’ NeXT Personal demonstrating significantly higher sensitivity in early-stage NSCLC patients compared to two previous publications on the cohort, including lung adenocarcinoma (LUAD), and the ability to classify patients into lower- and higher-recurrence risk groups. A phase 2 clinical trial led by the Johns Hopkins Kimmel Cancer Center  and the Canadian Cancer Trials Group (CCTG) has shown that liquid biopsies can identify early-stage lung cancer patients who may benefit from additional drug treatments during immunotherapy. The study demonstrated that ctDNA analyses could serve as an early marker of immunotherapy response, potentially guiding therapy for patients with advanced NSCLC and offering a new endpoint for clinical trials.

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1 | Grail Pathfinder Publication Offers Glimpse of Multi-Cancer Clinical Screening Impacts Final Study Results | Grail

2 | In New TRACERx Data, Personalis MRD Test Shows Improved Sensitivity With Potential Clinical Impact Tag Initial Results | Personalis

3 | Study Shows Utility of ctDNA Dynamics as Early Therapy Response Endpoint Final Results | Johns Hopkins University, Canadian Cancer Trials Group

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Additional Sources

1 | Lung Cancer Treatment Response, Outcomes Linked to Liquid Biopsy Profiles Preliminary Results | Southern Medical University, Guangdong Lung Cancer Institute and Chinese Thoracic Oncology Group, Geneplus-Beijing Institute

2 | Multimodal Cell-Free DNA Test May Help Detect Cancer Early in Li-Fraumeni Syndrome Patients Proof-of-principle Study | Hospital for Sick Children (SickKids), Ontario Institute for Cancer Research, Princess Margaret Cancer Centre

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M&A | VC | Private Equity | Legal

Precede Biosciences has unveiled a new blood-based platform for in-depth profiling of disease-related gene and pathway biology from just 1 mL of plasma. With $57 million in funding, they aim to provide insights into disease biology, treatment targets, and response, offering a non-invasive alternative to tissue-based tests in clinical practice. Biocept filed for Chapter 7 bankruptcy after laying off 35% of its workforce earlier in the year and reporting a decline in second-quarter revenues to $589,000 from $5.8 million a year ago, primarily due to reduced COVID-19 testing volume. Swiss diagnostics developer 4D Lifetec sells 20% stake  to investment firm Xlife Sciences for CHF 23.3 million ($25.9 million), granting access to Xlife's AI-based digital health software to enhance its early cancer detection technology.

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1 | Liquid Biopsy Company Precede Biosciences Emerges From Stealth With $57M in Financing Financing  | Precede Biosciences

2 | Biocept Files for Chapter 7 Bankruptcy Bankruptcy| Biocept

3 | 4D Lifetec to Sell 20 Percent Stake to Xlife Sciences for $25.9M Stake Acquisition | 4D Lifetec, Xlife Sciences

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Additional Sources

1| City of Hope, TGen Win $4.5M Grant to Advance Pancreatic Cancer Liquid Biopsy Screening Pancreatic Cancer Financing | City of Hope, Translational Genomics Research Institute

2 | UCLA receives grant to improve liquid biopsy for early lung cancer detection Saliva-based EDx Financing | UCLA Jonsson Comprehensive Cancer Center, UCLA School of Dentistry