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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Featured DeciBio Insights

1 | Executive Roundtable: Navigating the FDA's Laboratory Developed Tests Regulation Webinar Webinar | DeciBio

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Clinical and Regulatory

FDA’s Oncologic Drugs Advisory Committee voted 12 to 0 that the totality of available data supports the use of minimal residual disease (MRD) as an end point for accelerated approval of new treatments for patients with multiple myeloma. Devyser received IVDR approval for its software for monitoring donor-derived cell-free DNA (dd-cfDNA) in patients following kidney transplantation, as part of the One Lambda Devyser Accept cfDNA assay.

1 | FDA’s ODAC Recognizes MRD as an Accepted End Point for Accelerated Approval in Multiple Myeloma Novel Endpoint | FDA ODAC  

2 | Devyser receives IVDR approval for post-transplant monitoring software Regulatory Approval | Devyser

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Company Announcements & Product Launches

Predicine announced a collaboration with Apollomics to develop PredicineCARE as a companion diagnostic in NSCLC. Early is Good announced a collaboration with Mayo Clinic to develop a multi-omic liquid biopsy test to enable comprehensive care plans for men with advanced prostate cancer. ANGLE and AstraZeneca also announced a collaboration to adapt ANGLE’s Parsortix-based assay for identifying micronuclei in circulating tumour cells (CTCs) to enhance cancer drug development through better understanding and targeting of tumor-specific DNA repair mechanisms. City of Hope announced a collaboration to utilize DELFI’s FirstLook Lung, a blood-based lung cancer screening test, in a City of Hope clinical study to help improve screening rates in underserved communities in Los Angeles County. Bio-Rad also announced a collaboration with Allegheny Health Network to generate clinical evidence for using Bio-Rad’s ddPCR technology for tumor-informed molecular residual disease (MRD) monitoring in the adjuvant setting in solid tumors.

1 | Predicine Announces Collaboration with Apollomics to Develop Companion Diagnostic in NSCLC Partnership | Predicine & Apollomics  

2 | Early is Good Announces Collaboration with Mayo Clinic to Develop a Comprehensive Liquid Biopsy Test for Men with Advanced Prostate Cancer Collaboration | Early is Good & Mayo Clinic

3 | ANGLE inks AstraZeneca deal to develop ground-breaking cancer assay Partnership | Angle & AstraZeneca

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Clinical Trials & Study Results

Freenome announced topline results from PREEMPT CRC for its early cancer detection platform, demonstrating 79.2% sensitivity in detecting colorectal cancer (Stage I: 57.1%, Stage II: 100%, Stage III: 82.4%, Stage IV: 100%) with 91.5% specificity for non-advanced colorectal neoplasia. Natera and the Alliance for Clinical Trials in Oncology announced the launch of Alliance A032103 (MODERN), a phase II/III trial using Signatera to help guide personalized treatment after radical cystectomy in muscle-invasive urothelial cancer (MIUC). Natera also announced surveillance data from Phase III IMvigor011 trial in MIUC that suggested patients who remain MRD-negative on serial testing may be spared from adjuvant treatment. Naveris announced the launch of a Phase II clinical study in minimal residual disease positive (MRD+) HPV-driven head and neck cancer to evaluate the efficacy of HB-200 in HPV16+ head and neck squamous cell cancer (HNSCC) with molecular relapse. Serum Detect presented a machine learning model for lung cancer status prediction using circulating TCR repertoire functional units (RFUs) at AACR. The model showed sensitivity of nearly 50% for stage I lung cancers at a specificity of 80%.

1 | Freenome Announces Topline Results for PREEMPT CRC® to Validate the First Version of its Blood-Based Test for the Early Detection of Colorectal Cancer Study Data | Freenome

2 | Natera and Alliance for Clinical Trials in Oncology Announce Activation of Alliance A032103 (MODERN): A Randomized, Phase II/III Adjuvant Trial in Urothelial Cancer | Study Announcement | Natera

3 | Naveris Announces Launch of Phase II Clinical Study in MRD+ Head and Neck Cancer Study Launch | Naveris

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M&A | VC | Private Equity | Legal

PlaqueTec raised $8 million in equity financing to support PlaqueTec’s ongoing BIOPATTERN trial, designed to improve understanding of CAD pathobiology and how it varies between individuals and to build BIOCARTA, its novel biomarker discovery tool. The European Commission has approved Illumina’s planned divestment of Grail although no divestment plan has been finalized. Illumina must capitalize Grail with around $1 billion if it spins off the cancer screening company to create an independent business. Freenome announced elimination of over 100 jobs, or about 20% of its staff, in a restructuring to align with strategic priorities.

1 | PlaqueTec secures $8M to transform treatment of coronary artery disease Private Financing | PlaqueTec

2 | European Commission approves Illumina’s proposed Grail split Divestiture | Illumina & Grail

3 | Freenome to cut more than 100 employees in restructuring Layoff Announcement | Freenome

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Additional Sources

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Company Announcements & Product Launches

1 | City of Hope and DELFI Diagnostics announce collaboration to improve lung cancer screening rates in underserved areas of Los Angeles | Collaboration Announcement | City of Hope & DELFI Diagnostics

2 | Bio-Rad and Allegheny Health Network Cancer Institute Partner to Advance Personalized Monitoring of Solid Tumor Cancers with Droplet Digital PCR Partnership | Bio-Rad & Allegheny Health Network Cancer Institute

3 | SOPHiA GENETICS Announces Syndicate Bio as First Liquid Biopsy Customer in Africa Geographic Expansion | SOPHiA GENETICS & Syndicate Bio  

4 | An Exosome-based Liquid Biopsy Shows Promise for Early Detection of Pancreatic Cancer AACR Results | City of Hope

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Clinical Trials & Study Results

1 | Natera Announces Positive Surveillance Analysis from the Randomized Phase III IMvigor011 Trial in Muscle-Invasive Bladder Cancer Study Data | Natera

2 | Serum Detect Presents Data on Novel T-Cell Analysis Approach for Cancer Early Detection at AACR Study Data | Serum Detect  

3 | Harvard Med Team Advancing New Sequencing Assay for Screening HPV-Associated Throat Cancer Study Results | Harvard Medical School

4 | New urine-based test detects high-grade prostate cancer, helping men avoid unnecessary biopsies Study Data | University of Michigan Rogel Cancer Center

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