‍Highlights & Summary

Liquid Biopsy (LBx) continued to develop through December, featuring new clinical and research collaborations, many study results and trial launches, and M&A updates.

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Featured DeciBio Insights

1 | Precision Neurology 2025: The Year of Biological Definition

2 | Proteomic Tools 2025: The Year of Multiomic Convergence

3 | Pharma Services in Review: 2025 Events to Shape 2026

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Clinical and Regulatory

Policlinico Gemelli and Guardant Health announced the successful launch of FPG 360, an in-house liquid biopsy testing service at Policlinico Gemelli in Rome, Italy. FPG 360 is one of the first dedicated liquid biopsy testing facilities in Italy housed within a hospital system, though Guardant has had previous partnerships with European academic and research hospitals to expand access to its tests. Guardant also received approval from Japan’s Ministry of Health, Labour, and Welfare for use of Guardant360 CDx as a companion diagnostic to identify ESR1 mutations in HR+, HER2- breast cancer patients with disease progression following endocrine therapy for treatment with Eli Lilly’s Inluriyo.

1 | Guardant Health and Policlinico Gemelli Launch In-House Liquid Biopsy Testing Service in Italy Collaboration | Guardant Health, Policlinico Gemelli

2 | Guardant Health Blood Test Receives Japanese Approval as CDx for Eli Lilly Breast Cancer Drug CDx Approval | Guardant Health, Eli Lilly

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Company Announcements & Product Launches

Pillar Biosciences and AstraZeneca have expanded their partnership with Shanghai Zhengu Biological Technology Co. to improve access to NGS-based kitted liquid biopsy tumor profiling in China. Through the collaboration, the companies will work to support implementation of Pillar’s technology in local hospital labs. Guardant Health announced a collaboration with Trial Library, an AI technology company enabling oncology clinical trials, to increase access to cancer clinical trials. The collaboration combines Guardant Health’s diagnostics capabilities with Trial Library’s AI-powered matching and patient navigation platform. Guardant Health and Global Healthy Living Foundation also announced a partnership to advance awareness of early colorectal cancer detection. The partnership aims to improve access to screening through patient-centered education. Singlera Genomics and Pure Medical entered a research and distribution agreement and will collaborate with local universities, hospital networks, and national healthcare systems on research studies across western Europe, along with commercial distribution of Singlera’s mTitan and mGuard early cancer detection tests in several European countries.  

1 | Pillar Biosciences and AstraZeneca Expand Liquid Biopsy Access Partnership to China Partnership Expansion | Pillar Biosciences, AstraZeneca, Shanghai Zhengu Biological Technology Co.

2 | Guardant Health Announces Collaboration with Trial Library to Increase Access to Cancer Clinical Trials Across the U.S. Partnership | Guardant Health, Trial Library

3 | Global Healthy Living Foundation and Guardant Health Announce Partnership to Advance Awareness of Early Colorectal Cancer Detection and Improve Access to Screening Partnership | Guardant Health, Global Healthy Living Foundation

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Clinical Trials & Study Results

Natera presented new data at ASH demonstrating the utility of personalized ctDNA monitoring in lymphoma for tracking disease burden and relapse risk, including studies with both its Signatera assay and Foresight Diagnostics’ CLARITY assay. In breast cancer, Natera, in combination with Alliance Foundation Trials and the Austrian Breast and Colorectal Cancer Study Group, presented initial phase III PALLAS results that showed Signatera provides strong post-surgical prognostic stratification in high- and intermediate-risk HR+/HER2- patients. Natera also published results from phase III CALGB (Alliance)/SWOG 80702 study and new findings from I-SPY 2. Personalis announced the publication of results from a new study in Spain using its ctDNA platform NeXT Personal to monitor immunotherapy response across multiple solid tumors, showing that early ctDNA dynamics are highly prognostic. Exact Sciences announced the first clinical study results from the NSABP B-59 substudy using its Oncodetect MRD test in breast cancer, showing detection of ctDNA was strongly associated with distant recurrence.  

1 | Natera Highlights New Findings in Lymphoma at the ASH Annual Meeting Study Results | Natera

2 | Phase III PALLAS Study Shows Signatera™ MRD Testing Provides Powerful Post-Surgical Prognostic Information in Patients with High and Intermediate Risk HR+/HER2‑ Breast Cancer Study Results | Natera

3 | Personalis Announces New Publication Applying Ultrasensitive ctDNA Testing to Monitoring Cancer Immunotherapy Response Across Solid Tumors Study Results | Personalis

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M&A | VC | Private Equity | Legal

Natera acquired Foresight Diagnostics, giving Natera access to Foresight’s phased variant technology which has a reported performance of LOD95 of 0.3 parts per million (ppm) and Foresight’s clinical research momentum in B-cell lymphomas. Freenome made plans to go public in a deal that could raise $330M, money it plans to use to develop and commercialize blood-based cancer detection tests. The deal will occur through a merger with a special purpose acquisition company (SPAC), bypassing the traditional initial public offering route. Natera voluntarily dismissed its appeal after a court ruled in favor of NeoGenomics, finding Natera’s asserted patent claims against NeoGenomics’ RaDaR ST test are invalid. NeoGenomics aims for a clinical launch of RaDaR ST in the first quarter of 2026.

1 | Natera Acquires Foresight Diagnostics Acquisition | Natera, Foresight Diagnostics

2 | Freenome inks deals to list stock and raise $330M SPAC | Freenome

3 | NeoGenomics Announces that Natera Has Voluntarily Withdrawn its Appeal in Ongoing RaDaR Patent Litigation Appeal Withdrawal | Natera, NeoGenomics

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Additional Sources

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Company Announcements & Product Launches

1 | Singlera Genomics Signs European Distribution and Research Agreement with Pure Medical for Cancer Detection Products EU Distribution and Research Agreement | Singlera Genomics, Pure Medical

2 | Singlera Genomics announces research collaboration with the University of Pittsburgh to advance pancreatic cancer early detection Research Collaboration | Singlera Genomics, University of Pittsburgh

3 | Vincere Cancer Center Begins Recruitment for Clinical Studies of Pioneering Breast Cancer Screen for Women at High Risk Trial Initiation | Syantra, Vincere Cancer Center

4 | TrilliumBiO and Oncobit Partner to Bring Novel Uveal Melanoma Monitoring Solution to the U.S. Partnership | TrilliumBiO, Oncobit

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Clinical Trials & Study Results

1 | Natera Announces Publication of Signatera™ Analysis from Randomized, Phase III CALGB (Alliance)/SWOG 80702 Study in Colorectal Cancer Study Results | Natera

2 | I-SPY 2 Publication in Nature Communications Shows Signatera™ Can Predict Treatment Response and Recurrence Risk in Early-Stage Breast Cancer Study Results | Natera

3 | Exact Sciences, the NSABP Foundation, and the German Breast Group Present Results for the Oncodetect® MRD Test in Early Triple-Negative Breast Cancer at SABCS Study Results | Exact Sciences, NSABP Foundation, German Breast Group

4 | New Publication Demonstrates the Importance of NeXT Personal Ultrasensitive Detection of Residual Disease in Lung Cancer Study Results | Personalis

5 | Postoperative Lymph Is a Proximal Source of ctDNA for Detection of Recurrence in HPV-Independent Head and Neck Cancer Study Results | Droplet Biosciences, Mayo Clinic, University of Pittsburgh

6 | Exact Sciences Announces First Participant Enrolled in the CRANE Study, a Multi-Cancer Early Detection Clinical Evaluation in Japan Trial Initiation | Exact Sciences

7 | Natera and MEDSIR to Collaborate on the MiRaDoR Trial in Breast Cancer Trial Partnership Natera, MEDSIR

8 | Molecular Evidence of Multiorgan Damage in Patients with Immune-Related Adverse Events Study Results | Johns Hopkins University

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