‍Highlights & Summary

Marching on with more #LBx news! Last month brought regulatory and reimbursement updates, collaborations and launches, and new study results.

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Clinical and Regulatory

The FDA approved Myriad’s MyChoice CDx as a companion diagnostic (CDx) for Zejula (niraparib), a PARP inhibitor from GSK, for patients with advanced ovarian cancer. NeoGenomics announced the PanTracer LBx test has received Medicare coverage. PanTracer LBx is a CGP assay designed to support therapy selection and clinical trial enrollment. NCCN updated its guidelines to recommend tumor molecular profiling, preferably by NGS, to identify actionable mutations among pancreatic adenocarcinoma patients eligible for therapy. While tumor tissue testing is preferred, liquid biopsy (ctDNA) testing can be considered when tissue testing is not feasible. Invivoscribe announced its IdentiClone Dx IGH assay received IVDR certification. IdentiClone Dx serves as an adjunctive tool for evaluating patients suspected of having B-cell lymphoproliferative disorders.

1 | Myriad Genetics Receives FDA Approval of the MyChoice CDx Test as the Companion Diagnostic for Zejula (niraparib) for Patients with Ovarian Cancer FDA Approval | Myriad Genetics

2 | NeoGenomics’ PanTracer LBx Receives Medicare Coverage, Expanding Access to Comprehensive Liquid Biopsy Profiling Medicare Coverage | NeoGenomics

3 | NCCN Updates Pancreatic Adenocarcinoma Guidelines, Recommending NGS Profiling  Guideline Update | NCCN

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Company Announcements & Product Launches

Guardant Health announced a strategic collaboration with Quest to enable streamlined and accelerated access to the Shield CRC screening test across Quest’s nationwide network. Myriad Genetics announced the launch of the tumor-informed Precise MRD test with a select number of oncology practices for patients with breast cancer. Illumina and Labcorp announced an expanded collaboration to advance precision oncology through innovative applications of NGS. The collaboration will include co-commercialization of Labcorp’s PGDx elio plasma focus Dx alongside Illumina’s TruSight Oncology Comprehensive test for solid tumor profiling.

1 | Guardant Health’s Shield Blood-based Screening Test for Colorectal Cancer Now Accessible Through National Test Ordering and Collection Network of Quest Diagnostics Collaboration | Guardant Health, Quest Diagnostics

2 | Myriad Commercially Launches Precise MRD with Select Community Oncologists Product Launch | Myriad Genetics

3 | Illumina and Labcorp expand collaboration to broaden access to precision oncology testing” Collaboration Expansion | Illumina, Labcorp

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Clinical Trials & Study Results

Creatv Bio announced a collaboration with CytoDyn to provide its LifeTracDx liquid biopsy test to support a Phase 2 study evaluating CytoDyn’s leronlimab in combination in previously treated patients with relapsed/refractory metastatic CRC. Adela announced clinical validation results for use of its tissue-free test for monitoring immunotherapy response in advanced solid tumors. Natera announced data showing that Signatera was able to identify older women with early stage ER+/HER2- breast cancer who can be managed with endocrine therapy, without surgery. Natera also announced data highlighting clinical utility of Signatera in anal squamous cell carcinoma (ASCC) and locally advanced rectal cancer (LARC). Freenome announced initial development data for its lung cancer screening test, showing adjusted sensitivity of 90.7% at 50% specificity and 80.4% at 75% specificity for detecting lung cancer.  

1 | Creatv Bio's LifeTracDx® Blood Test Utilized as Exploratory Biomarker in CytoDyn's Phase 2 Study in Patients with Relapsed/Refractory Metastatic Colorectal Cancer Clinical Trial Collaboration | Creatv Bio

2 | Adela Announces Study Published in NPJ Precision Oncology Clinically Validating its Tissue-Free Test to Monitor Immunotherapy Response in Advanced Solid Tumors New Study | Adela

3 | Signatera™ MRD Identifies Breast Cancer Patients Who Can Forgo Surgery

Study Results | Natera

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M&A | VC | Private Equity | Legal

Hepion Pharmaceuticals announced that it has in-licensed an assay from Cirna Diagnostics that detects mutant ctRNA to facilitate early diagnosis of HCC in high-risk cirrhotic patients. Virchow Medical announced it has completed a $4M seed financing led by Cerberus Ventures. The working capital will be used to complete development of the world’s first liquid specimen biorepository, the Virchow Vault.  

1 | Hepion Pharmaceuticals In-Licenses ctRNA Biomarker Assay to Facilitate Early Diagnosis and Surveillance of Hepatocellular Carcinoma Licensing Deal | Hepion Pharmaceuticals

2 | Virchow Raises $4 Million to Advance Biopsy Specimen Stewardship and Expand Access to Precision Oncology Seed Financing | Virchow Medical

‍Additional Sources

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Clinical and Regulatory

1 | Invivoscribe® Expands IVDR Portfolio with IdentiClone® Dx IGH Assay Certification Regulatory Approval | Invivoscribe

Company Announcements & Product Launches

1 | Foundation Medicine Announces Expanded Participation in National Cancer Institute’s ComboMATCH Platform Trials Through Inclusion of Its High-Quality Blood-Based Biomarker Test, FoundationOne®Liquid CDx Expanded Trial Participation | Foundation Medicine, ECOG-ACRIN Cancer Research Group, NCI

2 | Novigenix AI Spin-Out to Accelerate AI-Powered Immune Intelligence Company Launch | Novigenix

3 | Endometrics Wins First Prize in NIH RADx Tech ACT ENDO Challenge Challenge Win | Endometrics

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Clinical Trials & Study Results

1 | Freenome Reports Data for Multiomic Blood-Based Screening Test for Lung Cancer

Study Results | Freenome

2 | Two Publications Highlight Clinical Utility of Signatera™ in Anal and Rectal Cancers

Study Results | Natera

3 | Volition Reports Breakthrough in Liquid Biopsy: Achievement of over 99% Purity in Isolating Cancer DNA Publication | Volition

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