‍Highlights & Summary

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

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Clinical and Regulatory

Signatera Receives Regulatory Approval in Japan for Colorectal Cancer –  Natera received PMDA approval for Signatera in adjuvant colorectal cancer, establishing the first PMDA-approved minimal residual disease test in Japan

Regulatory Approval | Natera

UnitedHealth Group Now Covers Guardant Health’s Shield Blood Test for Colorectal Cancer Screening – Guardant Shield™ CRC screening blood-based test gained coverage from UnitedHealth Group, making it the first major commercial insurer to cover the test, expanding access to Shield™ for more than 40 million Americans

Insurer Coverage | Guardant, UnitedHealth Group

NCCN Recommends ctDNA-MRD Testing Using Signatera™ Technology in Landmark Bladder Cancer Guideline Update – The NCCN updated its Bladder Cancer guidelines to recommend multiplex PCR MRD testing, as used by Natera’s Signatera, for risk stratification and the use of adjuvant immunotherapy

Guideline Update | NCCN, Natera

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Company Announcements & Product Launches

Caris Life Sciences Launches Caris Detect, the World’s Most Sensitive and Comprehensive Multi-Cancer Early Detection Blood Test – Caris Life Sciences launched Caris Detect, a multi-cancer early detection (MCED) blood test that pairs whole-genome and whole-transcriptome sequencing with AI models built on Caris’ molecular profiling database, which includes over 1 million cases and 50 billion molecular markers

Product Launch | Caris Life Sciences

Creatv Bio and Neovia Oncology Announce Strategic Partnership to Study Multiple Drug Resistance (MDR) in Solid Tumors – Creatv Bio and Neovia Oncology announced a strategic partnership under which Neovia will use Creatv’s LifeTracDx liquid biopsy platform, which analyzes circulating tumor cells and cancer-associated macrophage-like cells, to monitor drug targets and tumor response in clinical studies of NEV-801, an investigational therapy for advanced multiple drug-resistant solid tumors

Collaboration | Creatv Bio, Neovia

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Clinical Trials & Study Results

Personalis Highlights Early Colorectal Cancer Recurrence Detection and Ultrasensitive MRD Performance Across a Broad Set of Tumor Types at ASCO 2026 — Personalis presented NeXT Personal MRD clinical data across six solid tumor types and highlighted the prospective VICTORI study, where the NeXT Personal assay reached 100% sensitivity for CRC recurrence during surveillance and 82% sensitivity 4 weeks post-surgery

Study Results | Personalis, ASCO Data

Natera and Eledon Announce Strategic Partnership for Prospera™ Monitoring in Planned Phase 3 Kidney Transplant Trial — Natera announced a partnership with Eledon Pharmaceuticals to embed Natera’s Prospera kidney transplant assessment test into Eledon’s Phase 3 clinical trial of tegoprubart, the first use of Prospera for longitudinal surveillance in a large clinical trial / transplant study

Clinical Trial Collaboration | Natera, Eledon

Natera and Aveta Biomics Announce Strategic Partnership Supporting Global Phase 3 Registrational Trial of APG-157 in Head and Neck Cancer — Natera and Aveta Biomics announced a partnership to integrate Natera’s Signatera MRD test into AVTA 30-01, a global Phase 3 registrational trial of Aveta’s oral immunotherapy APG-157 in approximately 826 patients with locally advanced head and neck squamous cell carcinoma

Collaboration | Natera, Aveta Biomics

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M&A | VC | Private Equity | Legal

Grail Shareholders File Class Action Lawsuit Alleging Misleading Statements About MCED Performance in NHS-Galleri Trial — GRAIL investors filed a securities class action lawsuit claiming that the company made false and misleading statements about the likelihood of the landmark MCED NHS-Galleri clinical trial achieving its primary endpoint of a reduction in Stage III & IV diagnoses.

Lawsuit | GRAIL

Guardant Fails to Undo $83 Million Verdict in TwinStrand Biosciences Patent Suit — Guardant lost its bid to overturn the $83 million patent verdict in the 2023 sequencing patent lawsuit from TwinStrand Biosciences, with a federal judge ordering a 6% ongoing royalty to TwinStrand

Patent Lawsuit | Guardant, TwinStrand Biosciences

Mammogen Secures Up to $30 Million Series A Financing to Advance RNA-Based BreastMammogen Secures Up to $30 Million Series A Financing to Advance RNA-Based Breast Cancer Detection Platform — Mammogen closed a Series A of up to $30 million to advance clinical validation and commercialization of its genTRU-breast blood-based RNA biomarker platform for non-invasive breast cancer detection

Series Funding | Mammogen

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Additional Sources

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Clinical and Regulatory

1 | Guardant Health Announces FDA Approval of Guardant360 CDx as Companion Diagnostic for Boehringer Ingelheim’s HERNEXEOS®

FDA CDx Designation | Guardant Health, Boehringer Ingelheim

2 | FDA Approves FoundationOne®CDx and FoundationOne®Liquid CDx as Companion Diagnostics for TALZENNA® (talazoparib) in Combination with XTANDI® (enzalutamide) to Identify Patients with HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer

Regulatory Approval | Foundation Medicine  

3 | Personalis Enables Global Biopharma Support with CE-IVD Marked Specimen Collection Kits

Regulatory Approval | Personalis

4 | Quest Diagnostics Receives New York State Approval for Haystack MRD®, Broadening Patient Access to ctDNA Minimal Residual Disease Testing

Regulatory Approval | Quest Diagnostics  

5 | NCCN Expands CSF Molecular Profiling Recommendation to Inoperable High-Grade Glioma

Guideline Update | NCCN, Belay Diagnostics

6 | Zepto Life Technology Receives FDA Breakthrough Device Designation for Targeted Liquid Biopsy Test for Invasive Mold Infections

FDA BDD | Zepto Life Technology

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Company Announcements & Product Launches

1 | Natera and CytoDyn Announce Strategic Collaboration to Advance ctDNA-Guided Development and Molecular Response Analysis in Metastatic Colorectal Cancer

Collaboration | Natera, CytoDyn

2 | SOPHiA GENETICS and ARC Regulatory Collaborate to Support EU Clinical Trial Assay Development

Clinical Trial Collaboration | SOPHiA Genetics, ARC Regulatory

3 | Countable Labs and Promega Announce Co-Marketing Agreement to Facilitate End-to End Biological Sample Preparation and Rare Variant Detection

Collaboration | Countable Labs, Promega

4 | Royal Marsden to Expand Guardant360 Liquid Access to Experimental Cancer Medicine Centre through Cancer Research UK Grant

Access Expansion | Cancer Research UK, Royal Marsden, Guardant Health

5 | Biocartis Announces Agreement with City of Hope to Explore Development of Rapid Gene Signature Test for Early Detection of Pancreatic Cancer

Collaboration | Biocartis, City of Hope

6 | Tempus Announces Research Collaboration with Angiosarcoma Awareness, Inc. to Uncover Insights on Rare Cancers

Collaboration | Tempus AI

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Clinical Trials & Study Results

1 | Geneseeq Demonstrates Fragmentia-AI, an AI Model to Improve cfDNA Analysis Sensitivity and Generalizability using Shallower Sequencing

Novel Method | Geneseeq

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M&A | VC | Private Equity | Legal

1 | GRAIL Completes $110 Million Equity Financing With Samsung Entities

Investment | GRAIL, Samsung  

2 | SOPHiA GENETICS Signs Strategic Collaboration MOU with Leading Global Cancer Center

Collaboration | SOPHiA Genetics, MSKCC

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