‍Highlights & Summary

Liquid Biopsy (LBx) continued to develop through January, featuring new regulatory updates, collaborations and product launches, and study results.

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Featured DeciBio Insights

1 | Women of Precision Medicine 2026

2 | 2026: Precision Medicine From Exploration to Execution

3 | Upcoming Webinar: Building Cell Therapies That Scale

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Clinical and Regulatory

Guardant360 CDx was approved by the FDA as a companion diagnostic (CDx) for identifying BRAF V600E-mutant metastatic CRC for treatment with BRAFTOVI (encorafenib) combination therapy. The Miller-Meeks Bill was passed and signed into law, allowing FDA-approved MCED tests to be eligible for Medicare coverage at a reimbursement rate of ~$500, starting in 2029 and initially for ages 50 to 65. FDA provided draft guidance for industry with nonbinding recommendations on using MRD as an endpoint to support accelerated approval in multiple myeloma. Natera submitted Signatera CDx PMA for identifying benefit from atezolizumab in muscle-invasive bladder cancer (MIBC), and GRAIL announced the submission of the final module of its PMA application for its Galleri MCED test. BLOODPAC also published generic protocols for analytical validation of tumor-informed ctDNA MRD tests.

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1 | Guardant360 CDx gets FDA approval as CDx for Pfizer colorectal cancer combo FDA Approval | Guardant, Pfizer

2 | Miller-Meeks Bill to Detect and Prevent Cancer Signed Into Law Budget Appropriations Passage | US Government

3 | FDA draft guidance on using MRD for accelerated approval in multiple myeloma Guidance | FDA

4 | FDA premarket approval sought for Signatera CDx test in MIBC PMA Submission | Natera

5 | GRAIL Submits FDA Premarket Approval Application for the Galleri® Multi-Cancer Early Detection Test PMA Submission | GRAIL

6 | BLOODPAC publishes liquid biopsy MRD analytical validation standards Testing Standards | BLOODPAC

7 | Guardant Health’s Shield Blood Test for Colorectal Cancer Screening Now Available for U.S. Military Members and Families Coverage Decision | Guardant, TRICARE

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Company Announcements & Product Launches

SAGA Diagnostics launched its Pathlight MRD test in CRC. Natera launched a 21-gene Fetal Focus NIPT that showed overall 96% sensitivity and 98% population-weighted specificity in 294 total samples across the full 21 genes. Personalis announced the early access launch of Real-Time Variant Tracker, an option that allows its NeXT Personal MRD test to additionally report on detected resistance and therapeutically targetable mutations such as ESR1 mutations. BillionToOne announced a collaboration with Epic to integrate BillionToOne’s prenatal and oncology testing portfolio with Epic’s Aura diagnostics suite, allowing clinicians to directly order within Epic. Guardant announced a multi-year collaboration with Merck to support the development and commercialization of Merck’s oncology portfolio using the Guardant Infinity Smart platform. Caris partnered with Everlywell to launch Caris Detect (expected H1 2026), an MCED test using WGS.

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1 | SAGA Diagnostics launches Pathlight MRD for colorectal cancer Test Launch | SAGA Diagnostics

2 | Natera Launches 21-Gene Fetal Focus™ Single-Gene NIPT, Powered By Ultra-Sensitive LinkedSNP Technology Product Launch | Natera

3 | Personalis Pioneers Advancement in MRD Testing with the Launch of its Real-Time Variant Tracker Product Launch | Personalis

4 | BillionToOne Announces Collaboration with Epic to Expand Prenatal and Oncology Testing Across Healthcare EHR Integration | BillionToOne, Epic

5 | Guardant Health Announces Multi-Year Strategic Collaboration Agreement with Merck to Develop Companion Diagnostics and Commercialize New Cancer Therapies Using Guardant Infinity Smart Platform Partnership | Guardant, Merck

6 | Caris Life Sciences Partners with Everlywell to Launch Caris’ Forthcoming MCED Assay, Caris Detect Partnership | Caris Life Sciences, Everlywell

7 | Natera to Scale AI Foundation Models in Precision Medicine with NVIDIA Collaboration | Natera, NVIDIA

8 | Mirxes to Advance Cancer Screening in Thailand via Strategic N Health Partnership and Launch of First-of-its-Kind At-Home Diagnostic Kits Commercial Partnership | Mirxes, N Health

9 | Daisy Genomics + New Day Diagnostics partner to advance CRC test development Partnership | Daisy Genomics, New Day Diagnostics

10 | nRichDx + Hamilton automate liquid biopsy sample prep workflow Collaboration | nRichDx, Hamilton Company

11 | Pangea Laboratory and Gene Solutions Establish Strategic Collaboration to Advance Cancer Diagnostics in the United States Collaboration | Pangea Laboratory, Gene Solutions

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Clinical Trials & Study Results

Exelixis and Natera are collaborating on Exelixis-sponsored STELLAR-316 trial, a phase 3 trial evaluating zanzalintib with and without an immune checkpoint inhibitor in patients with resected stage II/III CRC. Natera published data validating its methylation-based, tissue-free assay Latitude in CRC from the observational GALAXY study. Personalis announced the publication of a new study showing the performance of NeXT Personal MRD in monitoring immunotherapy response across a range of advanced cancers. Belay Diagnostics published analytical and clinical validation data of Summit 2.0, a high-throughput CGP assay for CNS malignancies using NGS to analyze tumor-derived nucleic acids from cerebrospinal fluid (CSF).

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1 | Exelixis and Natera to Collaborate on STELLAR-316, a Phase 3 Pivotal Trial of Zanzalintinib for Patients with Colorectal Cancer Study Result | Natera

2 | Natera Publishes Clinical Validation of Latitude™ Tissue-Free MRD Test in Colorectal Cancer Study Result | Natera

3 | Personalis Announces New Publication Expanding Evidence for Ultrasensitive ctDNA Monitoring of Cancer Immunotherapy Response Across Solid Tumors Study Results, Personalis

4 | Belay Diagnostics publishes validation data for CSF genomic profiling test Validation Results | Belay Diagnostics

5 | Prospera™ Featured in Landmark Interventional Study Advancing Lung Transplant Care Study Result | Natera

6 | BillionToOne Northstar Select selected for Japanese lung cancer study (LC-SCRUM-TRY) Study Selection | BillionToOne, National Cancer Center Hospital East

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M&A | VC | Private Equity | Legal

Precede Biosciences announced it raised ~$84M in total financing. Precede Bio’s platform leverages machine learning to identify high-resolution, genome-wide transcriptional biology from a blood draw. Cyclomics raised €2.6 million to support development and commercialization of its liquid biopsy test for cancer detection. The EU’s Unified Patent Court rejected a preliminary injunction request from Guardant Health against Sophia Genetics’ MSK-ACCESS for alleged patent infringement.

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1 | Precede raises $84M to integrate liquid biopsy test alongside next-gen precision cancer drugs Series Funding | Precede Biosciences

2 | EU Patent Court Rejects Guardant Health Request for Preliminary Injunction Against Sophia Genetics Injunction Rejection | Guardant, Sophia Genetics

3 | Cyclomics raises €2.6 million to advance liquid biopsy diagnostics Seed Funding | Cyclomics

4 | Guardant Health, TwinStrand Biosciences Patent Lawsuit Remanded to Appeals Board Case Update | Guardant, TwinStrand Biosciences