‍Highlights & Summary

Liquid Biopsy (LBx) continued to develop through September, featuring new companion diagnostic approvals, R&D collaborations, and exciting new research in LBx.

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Clinical and Regulatory

1 | Guardant Health Announces Landmark FDA Approval of Guardant360® CDx as Companion Diagnostic for AstraZeneca’s ETCAMAH™ (camizestrant) in Advanced Breast Cancer

Guardant Health's Guardant360 CDx was approved as a companion diagnostic for AstraZeneca's ETCAMAH, a next-gen. oral selective estrogen receptor degrader (SERD) in HR+, HER2- breast cancer. This marks the first FDA-approved LBx CDx for longitudinal testing in breast cancer, approved to monitor patients every 3 months during therapy to identify emerging ESR1 resistance mutations and benefit in switching to ETCAMAH, even prior to radiographic progression.

FDA Approval | Guardant Health, AstraZeneca

2 | FDA Advisory Committee Votes In Favor of Approval of GRAIL’s Galleri® Multi-Cancer Early Detection Test

The FDA's Clinical Genetics Devices Panel of the Medical Devices Advisory Committee voted in favor of GRAIL's Premarket Approval application for its Galleri multi-cancer early detection test. The Committee voted on the test's safety, effectiveness, and whether its benefits outweigh risks, with a majority in favor in each vote.

FDA Review | GRAIL

3 | Signatera™ Receives Regulatory Approval in Japan as a Companion Diagnostic in Muscle-Invasive Bladder Cancer

Natera's Signatera test obtained approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) as a companion diagnostic for muscle-invasive bladder cancer. With this approval, Signatera is authorized as a tool to identify patients eligible for Roche/Genentech's Tecentriq immunotherapy.

PMDA Approval | Natera

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Company Announcements & Product Launches

1 | Abbott launches SimpleScreen™ CRC blood test, joining Cologuard Plus® in its colorectal cancer screening portfolio

Abbott launched its SimpleScreen CRC test in the U.S. The test is an FDA-approved, blood-based test for colorectal cancer, indicated for adults age 45 and older who are at average disease risk. The test is developed and manufactured by Freenome, and commercialized by Abbott alongside their Cologuard Plus stool-based test.

Product Launch | Abbott

2 | Biodesix Advances Two Complementary Approaches to Molecular Residual Disease (MRD) Monitoring

Biodesix is pursuing both tumor-informed and tumor-naive MRD testing. The company is developing ctDNA-based tests through a multi-year collaborations with Bio-Rad Laboratories and a newly launched collaboration with Thermo Fisher Scientific, respectively. Memorial Sloan Kettering Cancer Center will also collaborate with Biodesix to validate the MRD platforms.

Product Announcement | Biodesix, Bio-Rad, Thermo Fisher, Memorial Sloan Kettering

3 | Renew Biotechnologies Enters Collaboration to Evaluate NeuroLens® in Multiple Sclerosis and Related Neuroimmunologic Diseases

Renew Biotechnologies has announced a collaboration with Mayo Clinic for the clinical development of NeuroLens, Renew's cfDNA-based approach in multiple sclerosis and other neuroimmunologic diseases. The technology aims to bring minimally invasive biomarkers to CNS injury, and ultimately, to support individualized care.

Collaboration | Renew Biotechnologies, Mayo Clinic

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Clinical Trials & Study Results

1 | Largest MRD Study in Lung Cancer Highlights Strong Prognostic Value for Signatera™

Natera announced the largest MRD dataset in lung cancer, which was recently presented at the IASLC 2026 World Conference on Lung Cancer. The data include 1,129 resected NSCLC cases and span 2016 to 2025, with the company's Signatera test showing value for predicting patient outcomes including recurrence and death.

Study Results | Natera

2| Amplifyer Bio publishes liquid biopsy preclinical data showing up to a 100-fold increase in ctDNA recovery

Amplifyer Bio shared progress in its effort to develop humanized DNA-binding antibodies at the ctDNA International Symposium. The antibodies are intended to improve ctDNA capture for LBx assays, with a top candidate showing up to 100-fold improvement in ctDNA recovery.

Study Results | Amplifyer Bio

3| FIT and molecular tests versus colonoscopy: an economic evaluation of colorectal cancer screening in the United States

A new HEOR study led by researchers from Shenyou Bio and SeekIn investigated the economic case for non-colonoscopy CRC screening tools. The study found significant cost savings from these alternative methods and identified a FIT test-first approach as most cost-effective.

Economic Study Results | Shenyou Bio, SeekIn Inc.

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M&A | VC | Private Equity | Legal

1 | Veracyte Acquires Convergent Genomics, Expanding its Urology Diagnostics Portfolio with a Urinary Tumor DNA Testing Platform

Veracyte has acquired Convergent Genomics, adding the latter's UroAmp platform and proprietary urinary tumor DNA technology to Veracyte's arsenal. UroAmp has been validated clinically in bladder cancer for therapy response monitoring and surveillance, and Veracyte plans to commercialize its first test based on the technology in late 2028.

Acquisition | Veracyte, Convergent Genomics

2 | Grail’s Galleri Multi-Cancer Test Accused of Patent Infringement

Australian biotech company Clinical Genomics Technologies has filed a lawsuit against GRAIL, alleging that the Galleri multi-cancer early detection (MCED) test infringes on Clinical Genomics' patents. Specifically, the lawsuit claims that Galleri improperly uses technology designed for measuring cytosine methylation which Clinical Genomics developed.

Patent Lawsuit | Grail, Clinical Genomics Technologies

3 | Tempus AI Fails to Trim Guardant Lawsuit Over Diagnostic Tests

In other news, Tempus was unsuccessful in its effort to winnow Guardant Health's lawsuits, which accuse Tempus of patent infringement in the development of its molecular tests. Tempus failed to prove that Guardant's patents were invalid for indefiniteness, according to US District Court Judge Gregory B. Williams.

Patent Lawsuit | Guardant Health, Tempus AI

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Additional Sources

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Clinical and Regulatory

1 | Recommendations of the American Cancer Society workshop on design, conduct, analysis, and reporting of multicancer early detection trials with late-stage incidence end points and post-trial ongoing evaluation—The Peachtree Consensus

Trial Design Guidance | American Cancer Society

2 | FDA approves imlunestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer and Blood-Based Guardant360 CDx

CDx Approval | Guardant Health, Eli Lilly

3 | Guardant Health’s Shield Blood Test Covered by EviCore by Evernorth for Colorectal Cancer Screening

Coverage Policy Update | Guardant Health, Evernorth

4 | Guardant Health Expands Shield Blood Test Coverage Through Carelon

Coverage Policy Update | Guardant Health, Carelon

5| VB Spine Announces FDA Breakthrough Device Designation for New Blood Test Designed to Identify Patients at Risk for Scoliosis Progression

FDA BDD  | VB Spine

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Clinical Trials & Study Results

1 | Peripheral Blood as the Sole Source for Cancer Neoantigen and Reactive T-Cell Discovery

Study Results | Vall d'Hebron Institute of Oncology

2| Liquid biopsy for early detection of pancreatic ductal adenocarcinoma

Study Results | City of Hope

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M&A | VC | Private Equity | Legal

1 | Aitiologic raises €6.4m seed to advance preeclampsia risk test

Seed Funding | Aitiologic

2 | iPremom raises €15m to transform pregnancy care with molecular diagnostics

Seed Funding | iPremom

3 | Senticell® Awarded STTR Grant from the National Cancer Institute to Advance RBC-Based Liquid Biopsy for Early-Stage Lung Cancer

Grant Funding | Senticell, NCI

4 | Tempus Refiles HSR Notification for Personalis Acquisition, Resetting Antitrust Review of Tumor-Informed MRD Deal

Acquisition | Tempus AI, Personalis