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Highlights & Summary

Liquid Biopsy (LBx) continued to develop through June, featuring new trials and studies as well as funding rounds and legal developments.‍

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Company Announcements & Product Launches

BioAI announced a collaboration with Genomic Testing Cooperative (GTC) to enhance patient care in oncology. Goals of the collaboration include data access and AI training, biomarker development, and comprehensive solutions (including tissue and liquid CGP). Natera announced the launch of Prospera Heart with Donor Quantity Score (DQS), which normalizes for the background total cfDNA and results in a more accurate risk assessment, increasing sensitivity from 80.0% to 88.2% and specificity from 76.1% to 84.2%.  

1 | BioAI, Genomic Testing Cooperative Collaborate to Support Pharmas, Clinicians Strategic Collaboration | BioAI, Genomic Testing Cooperative (GTC)

2 | Natera Launches Differentiated New Feature for Prospera™ Heart Test, Enhancing Detection of Rejection for Transplant Patients New Feature | Natera

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Clinical Trials & Study Results

Natera announced DECIPHER, a phase II trial using Signatera to evaluate the efficacy of a HER2-directed ADC in gastroesophageal adenocarcinoma in the adjuvant setting. Patients who are Signatera-positive after neoadjuvant chemo will forgo standard-of-care adjuvant chemo and receive the investigational therapy. Allogene Therapeutics and Foresight Diagnostics announced the initiation of Phase 2 ALPHA3 trial, which is evaluating cema-cel as part of the 1L treatment regimen for newly diagnosed LBCL patients who are likely to relapse following R-CHOP based on the Foresight CLARITY MRD test. Naveris announced the publication of a study highlighting the role of NavDx, a Tumor Tissue Modified Viral (TTMV)-HPV DNA blood test, in resolving indeterminate findings during oropharyngeal cancer surveillance with 98% accuracy.  

1 | Natera Announces DECIPHER: A Phase II, Single-Arm Adjuvant Trial in Gastroesophageal Cancer Trial Announcement | Natera

2 | Allogene Therapeutics Initiates Pivotal Phase 2 Trial Investigating Cemacabtagene Ansegedleucel (cema-cel), an Allogeneic CAR T Product Trial Initiation | Allogene Therapeutics, Foresight Diagnostics

3 | New Multicenter Study Highlights Use of the NavDx® Test in Resolving Clinically Indeterminate Findings Study Results | Naveris

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M&A | VC | Private Equity | Legal

Guardant Health has sued Tempus AI, stating that Tempus’ liquid biopsy tests allegedly infringe five patents related to DNA-based cancer testing. Personalis has reached a settlement with Foresight Diagnostics, ending its patent infringement lawsuits. Personalis has granted Foresight a non-exclusive, worldwide license to certain patents for WGS-based MRD testing in exchange for tiered royalties on net sales of those tests. Illumina completed divestiture of GRAIL, which is now a public and independent company, though Illumina will maintain a minority share of 14.5% in the company. BillionToOne raised $130M in Series D funding, aiming to expand diagnostics options via their Northstar Select and Response and their UNITY Fetal Risk Screen tests. Rarity Bioscience closed $7M funding round which will be used to advance their mission to democratize nucleic acid mutation detection.

1 | Guardant Health Sues Tempus for Patent Infringement Patent Infringement Lawsuit | Guardant Health, Tempus

2 | Personalis, Foresight Diagnostics Settle MRD Testing Patent Lawsuit Lawsuit Settlement | Personalis, Foresight Diagnostics

3 | Illumina Completes Divestment of GRAIL Divestment | Illumina, GRAIL

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Additional Sources

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M&A | VC | Private Equity | Legal

1 | BillionToOne Raises $130M in Series D Financing Round Series D Financing Round | BillionToOne

2 | Rarity Bioscience Closes €6.5M Funding Round Led By Navigare Ventures Funding Round | Rarity Bioscience

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