‍Highlights & Summary

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

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Clinical and Regulatory

Guardant360 CDx secured FDA approval as a companion diagnostic for Arvinas/Pfizer's vepdegestrant (VEPPANU) in ESR1-mutant ER+/HER2- advanced breast cancer, marking the first FDA-approved liquid biopsy CDx for a PROTAC degrader and reinforcing ctDNA-based ESR1 detection as a therapy-selection biomarker. TCM Biotech received FDA Breakthrough Device Designation for CatCHimera, a tumor-informed liquid biopsy MRD platform for hepatocellular carcinoma that uses patient-specific HBV-host genome integration junctions, rather than somatic SNV/indel calls, as the circulating tumor biomarker. Caris Life Sciences announced that Caris ChromoSeq received MolDX approval, expanding access to a single comprehensive genomic profiling assay for myeloid cancers.

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1 | Guardant Health Receives FDA Approval for Guardant360® CDx as a Companion Diagnostic for Arvinas and Pfizer’s VEPPANU (vepdegestrant) for Patients with ER+/HER2- Advanced Breast Cancer with ESR1 Mutations Regulatory Approval | Guardant Health

2 | TCM Biotech receives FDA Breakthrough Device Designation for First Viral-Integration MRD Liquid Biopsy in Hepatocellular Carcinoma, Marking a New ctDNA Biomarker Class BDD Designation | TCM Biotech

3 | Caris Life Sciences Receives MolDX Approval for Caris ChromoSeq, Advancing Access to Comprehensive Genomic Profiling for Myeloid Malignancies Payor Approval | Caris Life Sciences

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Company Announcements & Product Launches

GRAIL announced a collaboration with Epic to embed Galleri ordering, structured results, and patient follow-up directly into Epic Aura, with broad availability targeted by the end of 2026 across ~450 health systems. The integration is expected to reduce administrative friction for clinicians, which is a critical barrier for MCED adoption. Guardant Health announced a multi-year strategic collaboration with Nuvalent to use the Guardant Infinity tissue and liquid biopsy platform to support Nuvalent's global oncology trials, develop CDx assays to support potential regulatory approvals, and co-commercialize approved drugs alongside Guardant CDx in major global markets. Precede Biosciences launched Precede Bio Insight, a research-use-only epigenomic liquid biopsy that infers genome-wide gene expression, pathway activity, and cell states from 1 mL of plasma using cfDNA fragmentation patterns combined with machine learning, extending liquid biopsy into functional transcriptional biology.

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1 | GRAIL Announces Integration of the Galleri® Test into Epic Electronic Health Record Platform to Expand Access Nationwide Collaboration | GRAIL

2 | Guardant Health Announces Multi-Year Strategic Collaboration with Nuvalent to Develop Companion Diagnostics and Support Potential Commercialization of Targeted Cancer Therapies Using the Guardant Infinity™ Platform Partnership | Guardant Health, Nuvalent

3 | Precede Biosciences Launches Precede Bio Insight™, a Genome-Wide Liquid Biopsy for Functional Tumor Biology at AACR 2026 Product Launch | Precede Biosciences

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Clinical Trials & Study Results

Ultima Genomics presented AACR 2026 data validating its ppmSeq whole genome sequencing approach for MRD detection, including a TRACERx lung cancer pilot showing single-digit parts-per-million ctDNA sensitivity, positioning WGS as a scalable alternative to bespoke tumor-informed panels. Natera announced that the Phase 2 ALPHA3 trial in first-line consolidation large B-cell lymphoma reported a positive interim futility analysis. The trial uses Natera's CLARITY MRD assay (Foresight's PhasED-Seq technology, now integrated post-acquisition) to identify high-risk patients post-1L chemoimmunotherapy. Personalis presented AACR 2026 data showing NeXT Personal ctDNA test detected residual cancer down to a median 1.92 parts-per-million across roughly 25,000 real-world samples, underscoring its use as an ultrasensitive monitoring tool.

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1 | Ultima Genomics releases groundbreaking TRACERx MRD data showing ppmSeq performance and unveils clinical progress of whole genome sequencing at inaugural global MRD Symposium at AACR 2026 Clinical Trial | Ultima Genomics

2 | Natera Highlights Positive Interim Futility Analysis from Allogene Therapeutics’ MRD-Guided ALPHA3 Trial in Large B-Cell Lymphoma Clinical Trial | Natera

3 | Personalis Highlights Clinical Impact of Ultrasensitive ctDNA Monitoring and New Therapy Resistance Tracking at AACR 2026 Study Results | Personalis

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M&A | VC | Private Equity | Legal

Roche announced a definitive merger agreement to acquire SAGA Diagnostics for up to $595M, with SAGA's Pathlight platform to be commercially launched and integrated under Foundation Medicine following an expected Q3 2026 close. A US District Court in Delaware ordered ArcherDx and Invitae to pay Natera a 30% ongoing royalty on post-injunction revenues from infringing MRD-related product sales, upholding the validity of all three of Natera's asserted MRD patents. Harbinger Health, backed by a $100M financing led by Flagship Pioneering, launched RESOLVE, a new category of blood-based multi-cancer detection tests powered by its Harbinger HX platform, with first products expected later in 2026.

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1 | Foundation Medicine to Strengthen Monitoring Portfolio with SAGA Diagnostics’ Tumor-Informed Molecular Residual Disease (MRD) Platform Acquisition | Foundation Medicine, SAGA Diagnostics

2 | Judge Awards 30% Ongoing Royalty to Natera for MRD-Related Patent Infringement by ArcherDx and Invitae Patent Lawsuit | Natera

3 | Harbinger Health Establishes RESOLVE™ as a New Category for Cancer Detection Following $100M Financing Round Series Funding | Harbinger Health

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Additional Sources

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Clinical and Regulatory

1 | City of Hope to Evaluate Quest Diagnostics' Haystack MRD® for Guiding Patient Management in Multiple Cancers Clinical Implementation | Quest Diagnostics 

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Clinical Trials & Study Results

1 | 20 Abstracts at AACR Highlight Scale, Innovation and Clinical Impact of Natera's Oncology Platform Clinical Results | Natera

2 | CytoDyn Presents New Leronlimab Data in Metastatic Colorectal Cancer Trial Leveraging Creativ Bio’s LifeTracDx Assay at AACR Annual Meeting 2026 Study Results | CytoDyn, Creativ Bio

3 | GeneCentric Announces AACR 2026 Data on Fragmentomics-Based ExpressCT™ Liquid Biopsy Technology Conference Presentation | GeneCentric

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M&A | VC | Private Equity | Legal

1 | QCDx Secures $7 Million in New Financing to Advance Liquid Biopsy Innovations Funding | QCDx

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