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Highlights & Summary

Liquid Biopsy (LBx) continued to develop through September, featuring new strategic collaborations, regulatory and reimbursement developments, and new study results.

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Featured DeciBio Insights

1 | The UAE's Emerging Role in Global Biotech and Precision Medicine Blog Article | DeciBio

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Clinical and Regulatory

The FDA approved FoundationOne CDx and FoundationOne Liquid CDx as companion diagnostics for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). ClearNote Health’s Avantect Ovarian Cancer Test received a new CPT PLA code, with a preliminary reimbursement rate recommendation of $1,160 from CMS. The Avantect test is intended for patients at high risk for ovarian cancer, measuring levels of 5hmc, copy number variants, and fragment sizes in cell-free DNA to detect disease early. Sysmex Inostics’ RAS-RAF-SEQ LDT has received New York State CLEP approval. RAS-RAF-SEQ identifies the five most relevant targets for cancers impacted by the RAS-RAF and PI3K signaling pathways, such as colorectal, pancreatic, gallbladder, ovarian, and lung cancers.

1 | U.S. Food and Drug Administration Approves FoundationOne®CDx and FoundationOne®Liquid CDx as Companion Diagnostics for Lynparza® (olaparib) in Combination with Abiraterone for Patients with BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer CDx Approval | Foundation Medicine  

2 | Avantect Ovarian Cancer Test Receives CPT Code and Preliminary Payment Determination from the Centers for Medicare and Medicaid Services PLA Code | ClearNote Health

3 | Sysmex Inostics’ RAS-RAF-SEQ Assay Receives New York State Department of Health CLEP Approval for Use in Clinical Trials Regulatory Approval | Sysmex Inostics

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Company Announcements & Product Launches

Pillar Biosciences announced a strategic partnership with AstraZeneca to expand laboratory access to molecular testing using rapid, NGS-based liquid biopsy tumor profiling panels for detection of genetic cancer variants. The collaboration will leverage Pillar Biosciences’ kitted NGS panels, including oncoReveal Core LBx, Essential LBx, and Fusion LBx. Nucleix and A. Menarini Diagnostics announced a long-term commercial agreement whereby A. Menarini Diagnostics will assume exclusive marketing of the non-invasive, urine-based Bladder EpiCheck test in Europe. Bladder EpiCheck can be used to detect and monitor recurrence of bladder cancer and upper tract urothelial carcinoma. AccuraGen also announced its AccuScan MRD solution, a WGS liquid biopsy assay that is tumor-informed but does not require custom reagents. AccuScan’s workflow includes intramolecular ligation and rolling circle amplification.  

1 | Pillar Biosciences Partners with AstraZeneca to Help Accelerate Access to Liquid Biopsy Testing Strategic Partnership | AstraZeneca, Pillar Biosciences

2 | A. Menarini Diagnostics and Nucleix Announce a Strategic Partnership for a Non-Invasive Bladder Cancer Test in Europe Strategic Partnership | A. Menarini Diagnostics, Nucleix

3 | AccuraGen Highlights New Developments in MRD Detection with AccuScan Whole-Genome Sequencing Solution Product Development | AccuraGen

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Clinical Trials & Study Results  

Exact Sciences presented data on its blood-based CRC screening assay, showing sensitivities of 88.3% for CRC and 31.2% for advanced precancerous lesions at specificity of 90.1% for negative samples confirmed by colonoscopy. The company also presented data from its multi-cancer early detection (MCED) blood test, showing an overall sensitivity of 54.8% with 98.5% specificity in cancers without SoC screening options (excluding lung) and 63.7% in the six most aggressive cancers with the shortest survival rates (esophagus, liver, lung, ovarian, pancreatic, and stomach). Natera presented data from GALAXY arm of the CIRCULATE-Japan trial in stages II-IV CRC that showed Signatera status was predictive of overall survival, was predictive of benefit from adjuvant chemotherapy, was the most significant predictor of recurrence, and that sustained Signatera clearance after adjuvant chemotherapy was associated with improved survival.

1 | Exact Sciences Presents Data Demonstrating Advancement in Blood-based Colorectal Cancer Screening at ESMO 2024 Study Results | Exact Sciences

2 | First of its Kind Colorectal Cancer Data from Prospective GALAXY Study Released at ESMO; Demonstrates Signatera's Ability to Predict Overall Survival Study Results | Natera

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M&A | VC | Private Equity | Legal

The District Court for the Middle District of North Carolina entered a permanent injunction against NeoGenomics’ accused RaDaR assay, which was preliminarily enjoined in December 2023. NeoGenomics has since announced it has resolved litigation with Natera regarding RaDaR 1.0 and cleared the feasibility stage with a new version of its RaDaR technology. BillionToOne has signed a $140 million nondilutive financing agreement with Oberland Capital Management. The additional funding will support its future growth and LBx portfolio, including UNITY Fetal Risk Screen and two oncology assays, Northstar Select and Response. Syantra has raised C$4.9M ($3.6M) in Series A-1 funding to advance the clinical validation and commercialization of its early breast cancer detection test. The Syantra Dx Breast Cancer utilizes a panel of gene expression markers from whole blood.  

1 | Court Orders Permanent Injunction Against NeoGenomics' Accused RaDaR Assay, as Case Enters New Phase Litigation Case | NeoGenomics, Natera

2 | BillionToOne Secures $140M Financing Agreement with Oberland Capital Investment | BillionToOne, Oberland Capital

3 | Syantra Raises $4.9M for Early Breast Cancer Detection Technology Series A Funding | Syantra

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Additional Sources

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Clinical & Regulatory  

1 | Foundation Medicine Awarded Contract by the U.S. Department of Veterans Affairs to Provide Tumor Molecular Profiling to Veterans with Cancer Business Contract | Foundation Medicine  

2 | Guardant Health and Policlinico Gemelli Announce Partnership to Establish A Dedicated In-House Liquid Biopsy Testing Service in Italy Hospital Partnership | Guardant Health

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Company Announcements & Product Launches

1 | Hedera Dx Launches AI-Enabled RWD Capabilities with First Patients Recruited in EMPATHY NSCLC: a Prospective, International, Decentralized, Multicenter, Real-World Utility Study for Liquid Biopsy Product Launch | Hedera Dx

2 | ANGLE Enters Agreement With NuProbe; Gets Worldwide Licence Option For NGS Panel Licensing Approval | ANGLE, NuProbe

3 | Europa Biosite to Distribute Micronbrane Medical’s mNGS Technologies Across Europe Distribution Deal | Micronbrane Medical, Europa Biosite

4 | EDX Medical Announces Agreement With Caris Life Sciences to Distribute Molecular Profiling in the United Kingdom and Nordic Countries Distribution Agreement | EDX Medical, Caris Life Sciences

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M&A | VC | Private Equity | Legal

1 | Prostate cancer breakthrough: Novigenix-led project receives €1.75M grant to improve patient outcomes using liquid biopsy technology Research Grant | Novigenix