‍Highlights & Summary

Liquid Biopsy (LBx) continued to develop through May, featuring new clinical and research collaborations as well as trial launches and study results.

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Clinical and Regulatory

The FDA approved Signatera CDx for use with adjuvant atezolizumab (Tecentriq) in muscle-invasive bladder cancer, marking the first-ever companion diagnostic approval in blood-based TI MRD testing. The approval establishes MRD status as formal treatment-selection criteria and solidifies Natera's Treatment on MRD (TOMR) framework as a regulatory endpoint for de-escalation in solid tumors. The FDA also approved Guardant360 Liquid CDx, making it the largest FDA-approved liquid biopsy panel, assessing a 100x wider genomic footprint than the prior Guardant360 CDx. CMS's MolDX program expanded Medicare coverage for Personalis' NeXT Personal tumor-informed MRD assay to include monitoring response to neoadjuvant therapy in patients with Stage II-III TNBC or HER2-positive breast cancer as well as immunotherapy monitoring for patients with late-stage solid tumors. The American Cancer Society (ACS) released updated guidelines that now include blood-based screening tests taken in a doctor’s office and updates to at-home testing options.

1 | Signatera™ CDx Approved by the FDA as a Companion Diagnostic in Muscle-Invasive Bladder Cancer (MIBC)

FDA Approval | Natera

2 | FDA Approves New Guardant360 Liquid CDx, the Largest FDA-Approved Liquid Biopsy Panel with a 100x Expanded Footprint

FDA Approval | Guardant

3 | Personalis Secures Fourth Medicare Coverage Decision for NeXT Personal®, Expanding Breast Cancer Coverage to Pre-Surgical Treatment Monitoring

Medicare Coverage | Personalis

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Company Announcements & Product Launches

Foundation Medicine launched FoundationOne MRD following the completion of Roche's acquisition of SAGA Diagnostics. FoundationOne MRD combines whole genome sequencing-identified structural variants with a personalized multiplex digital PCR fingerprint. SOPHiA GENETICS and Synnovis, one of England’s leading pathology providers, announced a collaboration to deliver MSK-ACCESS with SOPHiA DDM to lung and breast cancer patients across the U.K. as part of NHS England's "blood test-first" program. Helio Genomics announced a commercialization partnership with Syneos Health to drive broader adoption of HelioLiver, its blood-based test for early detection of hepatocellular carcinoma (HCC), which uses AI to analyze cfDNA methylation patterns, protein biomarkers, and patient demographics.

1 | Foundation Medicine Launches FoundationOne®MRD, First-of-Its-Kind Molecular Residual Disease Test to Combine Structural Variants and Digital PCR

Product Launch  | Foundation Medicine

2 | Synnovis and SOPHiA GENETICS Collaborate to Bring Blood-based Cancer Testing to Patients Across the U.K.

Collaboration | SOPHiA GENETICS, Synnovis

3 | Helio Genomics, Syneos Health Partner to Broaden Commercialization of Liver Cancer

Partnership | Helio Genomics

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Clinical Trials & Study Results

GRAIL announced full results from the NHS-Galleri trial, showing that annual Galleri testing reduced Stage IV diagnoses of 12 prespecified cancers (though the trial did not meet its primary endpoint of reducing Stage III/IV cancers in aggregate). Galleri also found more Stage I and II cancers than all cancers found through NHS’ existing single cancer screenings combined. GRAIL also shared results from the PATHFINDER 2 study that showed increased detection of cancers over standard-of-care, including new stage I and II detections. Natera announced a collaboration with Diakonos Oncology to use Signatera for longitudinal ctDNA monitoring in patients enrolled in Diakonos' DOC-RM Phase I/II trial of DOC1021 (dubodencel), a first-in-class personalized dendritic cell immunotherapy that received FDA Fast Track designation for unresectable or metastatic cutaneous melanoma. CelLBxHealth secured a collaboration with AdventHealth, one of the largest health systems in the U.S., to implement its Parsortix CTC platform in two multi-center studies, ACTION and SUNRISE, which will analyze blood CTC as an endpoint. Labcorp announced a clinical trial collaboration with Temple Health’s Fox Chase Cancer Center to evaluate Labcorp’s tumor-informed Plasma Detect Genome MRD to assess risk of recurrence in patients with early-stage NSCLC.

1 | GRAIL Reports Full Results From NHS-Galleri Trial Demonstrating Substantial Reduction in Stage IV Cancer Diagnoses at 2026 ASCO Annual Meeting

Clinical Trial | GRAIL

2 | Natera Announces Collaboration with Diakonos Oncology for Signatera™ in Refractory Melanoma

Collaboration | Natera, Diakonos

3 | CelLBxHealth Announces Collaboration with AdventHealth for Circulating Tumor Cell Platform to Be Used In Two Cancer Studies

Clinical Study | CelLBxHealth

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M&A | VC | Private Equity | Legal

CareDx entered an agreement to acquire Naveris for up to $260M, adding NavDx, a Medicare-reimbursed tumor-naive assay detecting HPV tumor tissue-modified viral (TTMV) DNA for post-treatment surveillance in head and neck and anal cancers, to its portfolio. Avant Genomics raised more than $3M from TitletownTech, Halyard Ventures, Virginia Venture Partners, CAV Angels, and Global Impact Fund to advance its Avant Source platform, a fully automated liquid biopsy sample preparation system that reduces manual handling, improves cell-free DNA yield, and cuts processing time.

1 | CareDx Announces Agreement to Acquire Naveris, A Leader in Viral-Mediated Cancer MRD Surveillance Testing

Acquisition | CareDx

2 | Avant Genomics Secures $3M+ in Funding to Accelerate First-in-kind Automated Platform for Liquid Biopsy Sample Preparation

Series Funding | Avant Genomics

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Additional Sources

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Clinical and Regulatory

1 | FDA Breakthrough Device Designation Marks Major Milestone for Gene Solutions' SPOT-MAS 10 Multi-Cancer Screening Test

BDD | Gene Solutions

2 | American Cancer Society Updates Colorectal Cancer Screening Guidelines to Include Guardant Health and Freenome Blood-Based Tests

ACS Guideline Update | Guardant, Freenome

3 | Personalis Receives Medicare Coverage for NeXT Personal® for Immunotherapy Monitoring Across Late-stage Solid Tumors

Medicare Coverage | Personalis

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Company Announcements & Product Launches

1 | Natera Announces Expansion in Austin, Creating What Is Believed to Be the Largest Sequencing Facility in the World

Infrastructure Expansion | Natera

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Clinical Trials & Study Results

1 | GRAIL Presents PATHFINDER 2 Results of More Than 35,000 Participants Showing the Galleri^® Test Substantially Increased Cancer Detection With Robust Performance and Favorable Safety at 2026 ASCO Annual Meeting

Clinical Trial | GRAIL

2 | Temple Health’s Fox Chase Cancer Center and Labcorp Collaborate to Test Ultra-Sensitive Blood-Based Assay for Early-Stage Lung Cancer Recurrence Risk

Collaboration | Labcorp

3 | Delfi Diagnostics Gives 'First Look' at Clinical Utility of cfDNA Assay in Lung Cancer Screening

Clinical Trial | Delfi Diagnostics