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Highlights & Summary

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

Company Announcements & Product Launches

AnHeart Therapeutics and Foundation Medicine enter a strategic collaboration to develop and gain regulatory approval for Foundation Medicine’s genomic profiling tests, FoundationOne®CDx and FoundationOne®Liquid CDx, as companion diagnostics for AnHeart’s ROS1 inhibitor, taletrectinib, in the U.S.The partnership aims to efficiently identify patients for potential taletrectinib treatment using Foundation Medicine's diagnostic expertise. Cancer Research UK and Guardant Health announced a collaboration to advance cancer detection and treatment precision by sharing technologies and insights. The partnership, focusing on clinical trials like the DETERMINE trial for rare cancers, may involve sharing data and samples from Cancer Research UK's network to validate Guardant's technologies and accelerate the development of cancer drugs and diagnostics. SeekIn Inc enters collaboration with Oncolnv to globally distribute their blood-based cancer detection tests, including OncoSeek, in twelve countries to address disparities in cancer care. The collaboration also facilitates future research initiatives, joint clinical trials, and the development of innovative cancer detection methodologies.

1 | AnHeart Therapeutics and Foundation Medicine Announce Collaboration to Develop Tissue-Based and Liquid-Based Companion Diagnostics for Taletrectinib, a ROS1 Inhibitor CDx Partnership | AnHeart Therapeutics, Foundation Medicine

2 | Cancer Research UK and Guardant Health Launch Collaboration to Advance Research and Clinical Development Activities Partnership | Guardant Health, Cancer Research UK

3 | SeekIn and OncoInv Collaborate to Expand the Global Accessibility of Multiple Cancer Detection Tests and Bridge Global Disparities in Cancer Distribution Partnership | SeekIn, OncoInv

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Clinical Trials & Study Results

Freenome has initiated the PROACT LUNG clinical study to validate its blood test for lung cancer screening. The prospective observational trial aims to assess the test's sensitivity, specificity, and predictive values over 12- and 24-month periods, and Freenome plans to seek FDA approval based on the study's data. Haystack Oncology is collaborating with Rutgers Cancer Institute to employ Haystack MRD in a clinical trial for early-stage triple-negative breast cancer patients. The partnership aims to use Haystack MRD to evaluate therapeutic response and provide molecular insights, particularly focusing on patients undergoing treatment with liposomal doxorubicin and carboplatin in the adjuvant setting. In a Phase II trial presented at the American Society of Hematology's annual meeting, analyzing ctDNA helped predict which newly diagnosed lymphoma patients might benefit from adding Roche's bispecific antibody Columvi (glofitamab) to a first-line chemotherapy regimen. The study showed 95% of patients having an objective response to Columvi plus R-CHOP, leading to a Phase III randomized trial comparing the activity of first-line Columvi plus R-CHOP against R-CHOP in large B-cell lymphoma patients.

1 | Freenome Starts PROACT LUNG Study for Blood-Based Lung Cancer Screening Test Trial Announcement | Freenome

2 | Haystack Oncology and Rutgers Cancer Institute Collaborate to Use Haystack MRD in Clinical Study of Early-Stage Triple-Negative Breast Cancer Trial Announcement | Quest Diagnostics, Haystack Oncology, Rutgers Cancer Institute

3 | Circulating Tumor DNA Helps ID First-Line Lymphoma Patients for Roche’s Columvi, R-CHOP Trial Results | Roche

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M&A | VC | Private Equity | Legal

Natera secures preliminary injunction in a patent infringement case against NeoGenomics Labs, restricting the sales and promotion of NeoGenomics' Radar MRD assay in the US. NeoGenomics plans to appeal the order to the US Court of Appeals for the Federal Circuit. The US District Court for the District of Delaware has issued a permanent injunction, ordering ArcherDx and Invitae to cease using products containing Natera's patented material in the Personalized Cancer Monitoring (PCM) context, except for certain exceptions like ongoing clinical trials and quality control. The U.S. District Court denied CareDx's summary judgment motion in Natera's patent infringement lawsuit over two Panorama prenatal testing assay patents, alleging that CareDx violated two patents related to DNA amplification technology in Natera's Panorama noninvasive prenatal testing assay.

1 | Natera Wins Preliminary Injunction Against NeoGenomics Labs, Preventing Sale of MRD Assay in US Injunction | Natera, NeoGenomics

2 | Court Grants Natera Injunction Against Invitae, ArcherDx in Use of Patented Products Injunction | Natera, ArcherDx, Invitae

3 | Court Denies Summary Judgment for CareDx in Natera’s Patent Infringement Case Motion Denial | Natera, CareDx

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Additional Sources

Company Announcements & Product Launches

1 | Personalis to Cut 65 Jobs in Cost-Cutting Move Layoff | Personalis

2 | Illumina Announces Decision to Divest GRAIL Divestiture | Illumina, GRAIL

3 | Aqtual Unveils Precision Medicine Platform With Blood-Based Rheumatoid Arthritis Test Product Launch | Aqtual

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Clinical Trials & Study Results

1 | BillionToOne Announces Global Collaboration to Provide its UNITY Fetal Antigen Clinical Trial Assay in Johnson & Johnson Phase 3 Clinical Trial of Nipocalimab in Hemolytic Disease of the Fetus and Newborn Trial Partnership | BillionToOne, Jonson & Johnson

2 | Distinct Hodgkin Lymphoma Subtypes Defined by Noninvasive Genomic Profiling Research Article, Liquid Biopsy Application | Stanford University