‍Highlights & Summary

Liquid Biopsy (LBx) continued to develop through July, featuring a big acquisition, new regulatory approvals, and study results.

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Clinical and Regulatory

1 | Natera Announces IVDR Certification for Signatera™ Across Multiple Cancers

Signatera received Class C certification under the EU In Vitro Diagnostic Regulation (IVDR), making it the first personalized tumor-informed MRD test for solid tumors to achieve IVDR marking

Regulatory Approval

2 | FDA Approves Freenome’s SimpleScreen™ CRC Blood-Based Screening Test; Abbott to Commercialize in the U.S.‍

‍The FDA approved SimpleScreen CRC, Freenome's cfDNA methylation and multiomics blood test for colorectal cancer screening in average-risk adults 45 and older. Freenome will receive a $100M approval milestone from Abbott in line with their commercial agreement signed in 2025

Regulatory Approval | Freenome  

3 | Personalis Accelerates Global Expansion with UKCA Marking for NeXT Personal®, Expanding MRD Access and Biopharma Support in Great Britain‍

‍Personalis announced that its NeXT Personal Dx test received UKCA (United Kingdom Conformity Assessed) marking, allowing clinical use of its ultrasensitive tumor-informed MRD assay across England, Wales, and Scotland, with Link Medical Solutions serving as its commercialization partner in Great Britain

Regulatory Approval | Personalis  

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Company Announcements & Product Launches

1 | Myriad Genetics Launches FirstGene® Multiple Prenatal Screen‍

‍Myriad Genetics announced the launch of FirstGene, the only lab test to run four prenatal genetic screens (fetal chromosome, fetal single-gene, patient carrier, and fetal RhD) simultaneously from a single maternal blood draw as early as eight weeks gestation, consolidating the cfDNA-based prenatal screening workflow

Product Launch | Myriad Genetics  

2 | Priority Health Collaborates With GRAIL as the First Michigan Health Plan to Offer the Galleri® Multi-Cancer Early Detection Blood Test to Employer Plans  

GRAIL announced an expanded collaboration with Priority Health, the third-largest provider-sponsored health plan in the US, enabling Michigan self-insured employer groups to add the Galleri MCED blood test to existing cancer screening coverage

Collaboration | GRAIL  

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Clinical Trials & Study Results

1 | Signatera™ MRD Outperformed AMERK Testing in Predicting Merkel Cell Carcinoma Recurrence in JAMA Dermatology Study

Natera announced results from a prospective, multicenter study published in JAMA Dermatology comparing Signatera to the Merkel cell polyomavirus antibody test (AMERK) for monitoring Merkel cell carcinoma (MCC), in which Signatera was a stronger predictor of recurrence

Study Results | Natera  

2 | Signatera™ MRD Test Predicted Overall Survival Benefit from Chemotherapy in Resected Metastatic Colorectal Cancer

Natera announced data from a study evaluating Signatera in patients with resected colorectal liver metastases, drawn from the GALAXY arm of CIRCULATE-Japan. The analysis indicates Signatera MRD status stratifies which MRD-positive patients derive meaningful survival benefit from adjuvant chemotherapy

Study Results | Natera  

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M&A | VC | Private Equity | Legal

1 | Tempus to Acquire Personalis, More Tightly Integrating Molecular Residual Disease (MRD) into Its AI-Enabled Precision Oncology Platform

Tempus AI announced a definitive agreement to acquire Personalis at $1.5B enterprise value in a primarily stock transaction expected to close in late 2026 or early 2027. The deal will incorporate Personalis' ultrasensitive, tumor-informed NeXT Personal MRD assay into Tempus' multimodal data and AI platform

Acquisition | Tempus, Personalis  

2 | Freenome Debuts as a Publicly Traded Company Focused on Blood-Based Early Cancer Detection

Freenome closed its business combination with Perceptive Capital Solutions Corp and began trading on Nasdaq under the ticker FRNM on July 21, generating roughly $310M in gross proceeds; proceeds will fund Freenome's cfDNA methylation and multiomics screening portfolio, AI/ML platform, and commercial infrastructure

Public Listing | Freenome

3 | Cancer MRD testing startup Pairidex raises $4.9M to commercialize RNA-based blood test

Pairidex closed a $4.89M seed round from an unnamed publicly held investor to accelerate commercialization of FusionMRD, a lab-developed RNA-based droplet digital PCR blood test for monitoring minimal residual disease in gene fusion-driven blood cancers

Fundraising | Pairidex  

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Additional Sources

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Clinical and Regulatory

1 | Finalized MolDx LCD Includes Expanded Coverage for Natera’s Prospera™ Portfolio

MolDx Coverage | Natera  

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Company Announcements & Product Launches

1 | Plus Therapeutics and Genomic Testing Cooperative Partner to Integrate Next-Generation Sequencing Into the CNSide® CSF Assay Platform

Collaboration | Plus Therapeutics, Genomic Testing Cooperative  

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M&A | VC | Private Equity | Legal

1 | GRAIL Faces Continued Securities Class Action Litigation Over NHS-Galleri Trial Disclosures

Legal | GRAIL

2 | Chemomab Therapeutics and Precision Medicine Pioneer Scipher Medicine Announce Merger Agreement to Advance Nebokitug in an AI-Powered Phase 2 Trial in Rheumatoid Arthritis

Merger | Chemomab Therapeutics, Scipher Medicine