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Highlights & Summary

Liquid Biopsy (LBx) continued to develop through November, featuring several funding rounds, litigation updates, and new guidance from FDA.

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Featured DeciBio Insights

1 | Emerging Applications and Platforms in Liquid Biopsy Webinar Webinar | DeciBio

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Clinical and Regulatory

The FDA approved FoundationOne Liquid CDx to be used as a companion diagnostic for tepotinib, intended for adult patients with metastatic NSCLC with MET exon 14 skipping alterations. The FDA also released a guidance document providing non-binding recommendations around ctDNA use in clinical trials for early-stage solid tumors, focusing on industry and drug development settings and especially highlighting considerations around MRD / monitoring applications. While the guidance does not recommend specific assays, it provides a list of different potential applications of ctDNA and different considerations for them (e.g., “an MRD assay should have high sensitivity and negative predictive value (NPV) for supporting de-escalation of treatment and high specificity and positive predictive value (PPV) for supporting escalation of treatment”). The guidance also suggests approaches for validation, recommending clinical specimens for confirming assay limit of detection or developing an appropriate set of reference materials to allow for comparability across multiple MRD assays.

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1 | U.S. FDA Approves FoundationOne®Liquid CDx as a Companion Diagnostic for TEPMETKO® (tepotinib) to Identify Patients with MET Exon 14 Skipping Alterations in Non-Small Cell Lung Cancer FDA CDx Approval | Foundation Medicine

2 | Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Guidance for Industry; Availability Guidance Document | FDA

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Company Announcements & Product Launches

Breakthrough Genomics announced a collaboration with the PRECEDE Consortium to advance the clinical evaluation and adoption of its BT-Reveal Early Pancreatic Cancer Test. The partnership offers Breakthrough Genomics access to a network of pancreatic cancer researchers, clinicians, and high-risk centers.

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1 | Breakthrough Genomics Joins Forces with the PRECEDE Consortium to Help Accelerate the Early Detection of Pancreatic Cancer EDx Collaboration | Breakthrough Genomics, PRECEDE Consortium

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M&A | VC | Private Equity | Legal

A jury awarded Guardant Health $292.5M in damages related to a false-advertising and unfair-competition lawsuit brought against Natera in 2021. The claims were not about Signatera’s performance but alleged misleading advertisements around the performance of the competing Guardant Reveal assay.  PrognomiQ announced $34M Series D financing, which will be used to advance development of an early detection test for lung cancer. In response to Qiagen’s patent infringement lawsuit, Zymo Research filed counterclaims of antitrust violations and interference, accusing Qiagen of using legal tactics to stifle innovation and hinder adoption of Zymo’s ‘breakthrough cfDNA technology’. OneCell Diagnostics also raised $16M in Series A funding, which will be used to expand its next-generation liquid biopsy test, OncoIndx Ikon to the U.S. market.

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1 | Jury Awards Guardant Health $292.5M in False-Advertising Lawsuit Against Natera Lawsuit | Guardant Health, Natera

2 | PrognomiQ Announces $34 Million Series D Financing to Advance Development of Early Detection Test for Lung Cancer with Multi-omics Platform Series D Funding | PrognomiQ

3 | Zymo Research Files Antitrust Counterclaims Against Qiagen, Alleging Misuse of Litigation to Stifle Innovation Antitrust Counterclaims | Zymo Research, Qiagen

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Additional Sources

M&A | VC | Private Equity | Legal

1 | OneCell Diagnostics Raises $16M in Series A Funding Series A Funding | OneCell