Liquid Biopsy | February Round-Up 2025

Highlights & Summary

February saw significant Liquid Biopsy (LBx) news, with many noteworthy company announcements including several relating to reimbursement, fundraising, and access.

Featured DeciBio Insights

1 | DeciBio Ranked Among the Best Consulting Firms by GenomeWeb, Vault Consulting 50, and Management Consulted

2 | AGBT 2025: DeciBio Highlights – NGS (and Roche) Reclaims the Spotlight

Other DeciBio Newsletters

AI / Machine Learning | February Round-Up 2025

Next-Generation Therapeutics | February Round-Up 2025

Digital Health and Informatics | January Round-Up 2025

Clinical and Regulatory

Natera announced that its Signatera test has met the requirements for coverage from the Centers for Medicare & Medicaid Services (CMS) Molecular Diagnostics Services Program (MolDX) for NSCLC patients. This decision expands on an earlier Medicare decision which covered Signatera’s use for immunotherapy monitoring in adjuvant and neoadjuvant settings with the coverage of surveillance in stage I-III patients. ClearNote Health also received good news, as they announced in February that their Avantect Pancreatic Cancer Test had been approved by the New York State Department of Health. With this approval, the test becomes available to clinicians in New York State as a tool for pancreatic cancer early detection. A new Labcorp test for treatment guidance also hit the market last month, with the availability of the Labcorp Plasma Complete ctDNA CGP solution for advanced tumors.

1 | Natera Announces Medicare Coverage of Signatera? for Surveillance in Lung Cancer Medicare Coverage | Natera ?

2 | ClearNote Health Earns Approval for Avantect? Pancreatic Cancer Test from New York State Department of Health CLEP Approval | ClearNote Health

3 | Labcorp Announces Clinical Availability of Liquid Biopsy Test to Guide Personalized Treatment Plans for Patients with Advanced Solid Tumors Clinical Availability | Labcorp

Company Announcements & Product Launches

Foresight Diagnostics announced the expansion of their strategic collaboration with Allogene Therapeutics. Through the partnership, Foresight’s MRD assay will be developed as a companion diagnostic for the treatment of LBCL patients with cema-cel in Allogene’s ALPHA3 trial. Lynx Dx has launched ordering of its MyProstateScore 2.0 test’s at-home collection format. The test is a urine test ordered by physicians and is eligible for Medicare reimbursement. Flatiron Health and Exact Sciences announced a new collaboration aimed at generating evidence for Exact’s MRD test, called Oncodetect. Using Flatiron’s platform, the first patient has already been enrolled in the effort, which will include a broad range of solid tumor types.

1 | Foresight Diagnostics Expands Strategic Partnership with Allogene Therapeutics to Advance Joint Development Activities Outside of the U.S. Across Europe, UK, Canada and Australia Expanded Collaboration | Foresight Diagnostics, Allogene Therapeutics

2 | Lynx Dx Launches Ordering for At-Home Collection Version of MyProstateScore 2.0 Commercial Launch | Lynx Dx

3 | Flatiron Health and Exact Sciences Partner to Advance Clinical Evidence Generation for Molecular Residual Disease Testing Partnership | Flatiron Health, Exact Sciences

Clinical Trials & Study Results

Researchers from the University of Washington and Fred Hutchinson Cancer Center published results demonstrating the value of a prenatal cfDNA WGS assay as a means of predicting preeclampsia risk. The test uses nucleosome accessibility to identify placental and endothelial dysfunction, and achieved 81% and 79% sensitivity in validation and external cohort analysis, respectively. Separately, a new pancreatic ductal adenocarcinoma (PDAC) serum protease activity assay was developed at Oregon Health and Sciences University. Named PAC-MANN, it achieved 98% specificity and 73% sensitivity in a blinded, retrospective study, and was combined with the CA 19-9 biomarker for 85% sensitivity and 96% specificity in the detection of stage 1 PDAC.

1 | Preeclampsia risk prediction from prenatal cell-free DNA screening Study | University of Washington, Fred Hutchinson Cancer Center

2 | Early detection of pancreatic cancer by a high-throughput protease-activated nanosensor assay Study | Oregon Health and Sciences University

M&A | VC | Private Equity | Legal

PacBridge Capital Partners has backed AI health tech startup Avitia with $5M in seed funding. Avitia’s technology aims to enable cancer centers to perform NGS tests in-house and reduce reliance on external laboratories, thereby improving NGS’s affordability and accessibility across geographies. Syantra has received funding from Alberta Innovates to expand clinical studies of its Onco-ID: Breast screening test. The funding complements funding from the US Department of Defense and will support a pilot study at the Mays Cancer Center at UT Health San Antonio managed by Jessica Trevi?o Jones, MD. Oncocyte has raised $29.1M through concurrent offering to existing investors and private placements. Bio-Rad was among the 5 largest shareholders who led the round. The funds are expected to fund Oncocyte’s FDA IVD transplant assay program.