Highlights & Summary
Liquid Biopsy (LBx) continued to develop through November, featuring new coverage decisions, including in MRD, and new partnerships and product launches.
Clinical and Regulatory
Personalis announced that Medicare will cover its ultrasensitive NeXT Personal® blood-based MRD test for recurrence surveillance in patients with stage II and III breast cancer, including HR+/HER2–, HER2+, and triple-negative subtypes, for up to six years of monitoring. Naveris announced that Palmetto GBA, through the Medicare MolDX program, has expanded coverage for the company’s NavDx blood-based test for molecular residual disease surveillance in patients with previously treated anal squamous cell carcinoma. The coverage determination follows multi-institutional clinical data demonstrating the test’s performance in detecting recurrence using tumor tissue-modified HPV DNA. California’s Medicaid program, Medi-Cal, began covering personalized minimal residual disease (MRD) testing from plasma, whole-genome sequencing for rare disease, and select genome-wide cytogenomic tests effective November 1, 2025.
1 | Personalis Receives Medicare Coverage for MRD Assay in Breast Cancer Coverage | Personalis
2 | Naveris Announces Expanded Medicare Coverage for the NavDx® Test in Identification of Molecular Residual Disease of Anal Squamous Cell Carcinoma Reimbursement | Naveris
3 | Medi-Cal Begins Covering MRD, WGS, and Other Genomic Tests Reimbursement | Medicaid
Company Announcements & Product Launches
SOPHiA GENETICS announced partnerships with Element Biosciences and Complete Genomics to integrate its AI-based DDM analytics platform with their sequencing systems for end-to-end precision medicine research workflows. The collaborations include co-marketing MSK-IMPACT and MSK-ACCESS oncology assays for use on Complete Genomics’ DNBSEQ-T1+ platform, supporting both liquid biopsy and solid tumor applications. Roche and Freenome announced a collaboration worth up to $200 million, including a $75 million equity investment, to commercialize Freenome’s blood-based cancer screening tests in international markets through distributed kit-based versions. Bio-Rad announced a global, exclusive license to commercialize the MyHPVScore blood-based digital PCR assay developed at the University of Michigan for detecting recurrence of HPV-positive head and neck cancer, with plans to offer it as a research-use-only test worldwide. The assay detects ctDNA from multiple high-risk HPV strains and has shown strong analytical and early clinical performance compared with NGS and commercially available HPV ctDNA assays. OGT announced the launch of its SureSeq Myeloid MRD Plus NGS Panel, an NGS panel that detects low frequency variants in key biomarkers in AML to identify Measurable Residual Disease. The test covers 16 biomarkers associated with AML, including FLT3 and NMP1.
1 | SOPHiA GENETICS pairs AI analytics with sequencing for precision medicine research Partnerships | SOPHiA GENETICS, Complete Genomics, Element Biosciences
2 | Roche Inks $200M-plus Licensing Pact for Freenome's Cancer Screening Blood Tests Commercialization | Roche, Freenome
3 | Bio-Rad to Commercialize UMich Digital PCR Assay for HPV-Positive Head and Neck Cancer Recurrence Commercialization | Bio-Rad, University of Michigan
Clinical Trials & Study Results
Exact Sciences reported results from its prospective ALTUS study showing that its Oncoguard Liver blood-based test demonstrated higher sensitivity for detecting early-stage hepatocellular carcinoma than ultrasound in more than 3,000 participants, achieving 64% sensitivity for very early-stage disease and 77% sensitivity for early-stage disease. In the TRACERx study, researchers analyzed 2,994 plasma samples from 431 patients using personalized ctDNA panels designed from tumor whole-genome sequencing, including Personalis’ NeXT Personal protocol, and reported that longitudinal, ultrasensitive tumor-informed ctDNA monitoring improved postoperative risk stratification and recurrence prediction in early-stage non-small cell lung cancer.
1 | Exact Sciences Announces Results from Landmark Study Demonstrating Superior Early Detection of Liver Cancer with Blood-Based Surveillance Test Trial Results | Exact Sciences
2 | Longitudinal ultrasensitive ctDNA monitoring for high-resolution lung cancer risk prediction Trial Results | Personalis
M&A | VC | Private Equity | Legal
Abbott announced a definitive agreement to acquire Exact Sciences for $105 per share in cash, valuing the company at approximately $21 billion in equity value, to expand its presence in cancer screening and precision oncology diagnostics. The transaction, expected to close in the second quarter of 2026 pending shareholder and regulatory approvals, will add products including Cologuard, Oncotype DX, MRD testing, and multi-cancer blood-based screening to Abbott’s diagnostics portfolio. BillionToOne raised $314 million in an upsized initial public offering of more than 5.2 million shares at $60 per share as the company debuted on the Nasdaq under the ticker BLLN. The company plans to use the proceeds to scale its noninvasive prenatal and cancer DNA testing businesses. Hepta announced a $6.7 million seed financing led by Felicis Ventures and Illumina Ventures and reported clinical data showing its cfDNA methylation–based AI platform detected patients with MASH and significant fibrosis with a diagnostic AUC of 0.86. The company’s approach analyzes genome-wide cfDNA epigenetic patterns from blood to identify organ-specific disease signals.
1 | Abbott to acquire Exact Sciences Aquisition| Abbott, Exact Sciences
2 | DNA test maker BillionToOne raises $314M in IPO, shares take a quick dip IPO | BillionToOne
3 | Illumina and Grail Veterans Launch Hepta With First Liquid Biopsy-Native AI That Detects Liver Disease With Tissue-Level Biological Insights Seed Funding | Hepta
Additional Sources
Company Announcements & Product Launches
1 | OGT expands MRD detection capabilities with new SureSeq Myeloid MRD Plus NGS Panel Panel Launch | OGT
