Highlights & Summary
Liquid Biopsy (LBx) continued to develop through October, featuring new clinical and research collaborations as well as trial launches and study results.
Clinical and Regulatory
Roche received FDA clearance for its Elecsys pTau181 blood test, the first approved assay for use in primary care to help rule out Alzheimer’s-related amyloid pathology in patients aged 55 and older with cognitive decline. The test measures phosphorylated Tau 181 in plasma to aid early assessment, enabling broader access to Alzheimer’s biomarker testing outside of specialty settings and improving referral efficiency for advanced evaluation. Mirxes received approval from China’s National Medical Products Administration (NMPA) for its GASTROClear blood test, the first non-invasive assay authorized for gastric cancer screening in the country. The approval, based on a clinical trial of nearly 9,500 participants, allows use in high-risk adults aged 45 to 74 and positions the company to expand commercialization efforts in China, including manufacturing and sales scale-up to meet expected demand. Gene Solutions and AMPATH announced the opening of an advanced genomics laboratory in Hyderabad, India, to expand access to next-generation sequencing (NGS)–based testing for reproductive health, cancer screening, and precision oncology. The collaboration combines Gene Solutions’ genomic expertise with AMPATH’s nationwide diagnostic network to offer tests such as triSure NIPT, SPOT-MAS, and K-TRACK, aiming to integrate genomic diagnostics into routine clinical care across India.
1 | Elecsys pTau181 becomes the only FDA-cleared blood test for use in primary care to rule out Alzheimer’s-related amyloid pathology FDA Approval | Roche Diagnostics
2 | Mirxes Announces NMPA Approval for GASTROClear™ in China, Paving the Way for Major Launch in Key Market NMPA Approval | Mirxes
3 | Gene Solutions and AMPATH Launch Advanced Genomics Laboratory in Hyderabad to Expand Access to Precision Medicine in India Access Expansion | Gene Solutions, AMPATH
Company Announcements & Product Launches
Guardant Health and Zephyr AI announced a strategic partnership to combine multimodal molecular data with artificial intelligence to advance biomarker discovery and drug response prediction in oncology. The collaboration aims to support biopharmaceutical research by integrating Guardant’s molecular and real-world data with Zephyr’s AI/ML analytics to improve targeted therapy development and personalized cancer treatment insights. Natera announced an expansion of its Fetal Focus single-gene noninvasive prenatal test (sgNIPT) to include 20 genes, building on its initial 5-gene panel launched earlier in 2025. Using the company’s LinkedSNP technology, the test is designed to detect challenging homozygous mutations and is being evaluated in the ongoing EXPAND clinical trial, which has enrolled about 1,700 participants to assess performance across a diverse population. Samsung C&T, Samsung Electronics, and GRAIL announced a strategic collaboration to bring GRAIL’s Galleri multi-cancer early detection (MCED) blood test to Asia, beginning with commercialization in South Korea and potential expansion to Japan and Singapore. As part of the agreement, Samsung will make a $110 million equity investment in GRAIL, and the companies will explore additional collaborations involving data integration, AI, and digital health platforms.
1 | Guardant Health and Zephyr AI Announce Partnership to Unlock Drug Response Predictions and Biomarker Insights Partnership | Guardant Health, Zephyr AI
2 | Natera Announces Expansion to 20 Genes for its Fetal Focus Single-Gene NIPT Test Update | Natera
3 | Samsung and GRAIL Announce Strategic Collaboration to Bring GRAIL’s Galleri® Multi-Cancer Early Detection Test to Asia Partnership | Samsung, GRAIL
Clinical Trials & Study Results
Natera reported results from the Phase III IMvigor011 trial, sponsored by Genentech, showing that its Signatera test, when used to guide adjuvant treatment with atezolizumab (Tecentriq) in muscle-invasive bladder cancer, was associated with a 41% improvement in overall survival and longer disease-free survival compared to placebo. The study also found that patients who remained Signatera-negative during surveillance had low recurrence risk without adjuvant therapy, supporting the test’s potential role in informing post-surgical treatment decisions. GRAIL reported results from its PATHFINDER 2 study showing that adding the Galleri multi-cancer early detection blood test to standard U.S. Preventive Services Task Force–recommended screenings increased overall cancer detection by more than seven-fold. In the trial of over 35,000 participants, more than half of Galleri-detected cancers were found at early stages, about three-quarters were cancer types without existing screening tests, and the test demonstrated 99.6% specificity with a 0.4% false-positive rate. Natera released new data from its PROCEED-CRC clinical trial showing its blood-based screening test detected advanced adenomas with 22.5% sensitivity and 91.5% specificity among 1,400 participants. The results, which build on earlier findings from the company’s early cancer detection program, support continued evaluation of Natera’s assay in the ongoing FIND trial, an FDA-grade study aimed at validating a blood-based screening test for colorectal cancer and precancerous lesions.
1 | Successful IMvigor011 Trial Achieves 41% Improvement in Overall Survival for Bladder Cancer Patients Trial Results | Natera, Genentech
2 | GRAIL PATHFINDER 2 Results Show Galleri Multi-Cancer Early Detection Blood Test Increased Cancer Detection More Than Seven-Fold When Added to USPSTF A and B Recommended Screenings Trial Results | GRAIL
3 | Natera Reports Strong Advanced Adenoma Data from Prospective PROCEED-CRC Trial, Demonstrating 22.5% Sensitivity and 91.5% Specificity Trial Results | Natera
M&A | VC | Private Equity | Legal
GRAIL announced a $325 million private placement financing involving participation from new and existing institutional investors, including Deep Track Capital, Farallon Capital Management, Hims & Hers, and Braidwell LP. The company plans to use the proceeds to support commercial operations, reimbursement efforts, and general corporate purposes, and expects the funding, along with other announced investments, to sustain operations into 2030, pending customary closing conditions. BillionToOne, a Menlo Park–based molecular diagnostics company developing prenatal and liquid biopsy tests, filed for a U.S. IPO on Nasdaq under the ticker BLLN. The firm reported $125.5 million in revenue and a $4.2 million net loss in the first half of 2025, with J.P. Morgan, Wells Fargo, and William Blair as underwriters.
1 | GRAIL, Inc. Announces $325.0 Million Private Placement Financing Investment | GRAIL
2 | Molecular diagnostics firm BillionToOne files for US IPO IPO | BillionToOne
Additional Sources
Company Announcements & Product Launches
1 | MVZ HPH Brings ctDNA Blood Test for Cancer Monitoring to Europe, Based on Haystack MRD Technology from Quest Diagnostics Test Launch | MVZ HPH Institute for Pathology and Hematopathology, Quest Diagnostics
2 | AccuGenomics and 1Cell.Ai Partner to Bring Ultra-Sensitive Liquid Biopsy Testing Across Asia, with Plans for U.S. Expansion Partnership | AccuGenomics, 1Cell.Ai
3 | Archerfish Precision Diagnostics and C2N Diagnostics Announce Strategic Collaboration to Bring Advanced Alzheimer's Diagnostic Testing to Singapore and Across Asia Partnership | Archerfish Precision Diagnostics, C2N Diagnostics
Clinical Trials & Study Results
1 | GRAIL and University of Oxford Present Long-Term Data From the SYMPLIFY Study Evaluating the Galleri Multi-Cancer Early Detection Test in Symptomatic Individuals at the Early Detection of Cancer Conference (EDCC) Study Results | GRAIL
2 | New Study Demonstrates Accuracy of Two Quest AD-Detect Tests for Alzheimer's Disease Diagnosis Study Results | Quest Diagnostics
3 | Tracking clonal evolution during treatment in ovarian cancer using cell-free DNA Study Results | MSKCC
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