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Highlights & Summary  

Liquid Biopsy (LBx) continued to develop through July, featuring new regulatory approvals and collaborations as well as legal developments.

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Featured DeciBio Insights

1 | Oncology Liquid Biopsy (LBx) Market Report 2024 – 2029 Market Report | DeciBio

2 | The Future of Clinical Oncology Next Generation Sequencing: Decentralized vs. Centralized Upcoming Webinar | DeciBio

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Clinical and Regulatory

The FDA approved Guardant’s Shield blood test for CRC screening in adults age 45 and older who are at average risk for the disease. Shield is the first blood test to be approved as a primary screening option for CRC by the FDA. The FDA also approved FoundationOne Liquid CDx as a diagnostic tool in addition to a tissue biopsy test to identify patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) who may benefit from niraparib and abiraterone acetate. Exact Science’s multi-cancer early detection (MCED) test also received an investigational device exemption (IDE) from the FDA, clearing its way for use in clinical studies.

1 | Guardant Health’s Shield™ Blood Test Approved by FDA as a Primary Screening Option, Clearing Path for Medicare Reimbursement and a New Era of Colorectal Cancer Screening FDA Approval | Guardant Health

2 | FDA Approves FoundationOne Liquid CDx as a Diagnostic Tool for BRCA-Mutated mCRPC Regulatory Approval | Foundation Medicine

3 | FDA Approves an Investigational Device Exemption (IDE) for Exact Sciences’ multi-cancer early detection (MCED) Test Investigational Device Exemption | Exact Sciences

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Company Announcements & Product Launches

Tempus announced an expanded collaboration with Remix Therapeutics, moving from licensing of specific, de-identified data cohorts into a broader, strategic alliance including sequencing support for Remix’s Phase I trial for REM-422. Labcorp also announced an expanded collaboration with Ultima Genomics to utilize its UG 100 sequencing solution and ppmSeq technology to explore new WGS clinical applications, including MRD in patients with early-stage solid tumor cancers through Labcorp’s Plasma Detect solution. Universiti Kebangsaan Malaysia (UKM) has signed a Memorandum of Understanding (MoU) with Mirxes, partnering to develop a blood-based early detection test for CRC in Malaysia.  

1 | Tempus Announces Expanded Data and Sequencing Collaboration with Remix Therapeutics Collaboration Announcement | Tempus, Remix Therapeutics

2 | Labcorp Expands Collaboration with Ultima Genomics to Advance Whole Genome Sequencing Applications and Oncology Testing Capabilities WGS Collaboration | Labcorp, Ultima Genomics

3 | UKM and Mirxes Partner to Develop Colorectal Cancer Early Detection Test in Malaysia New Partnership | UKM, Mirxes

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Clinical Trials & Study Results

Haystack Oncology announced a research collaboration with the CRCHUM, Universite de Montreal’s hospital research center, to utilize Haystack’s personalized MRD technology to evaluate treatment effectiveness in patients with metastatic colorectal cancer (mCRC) with metastases confined to the liver. The observational study will assess ctDNA as an early biological marker of treatment response and disease recurrence in patients undergoing systemic treatment and liver surgery with curative intent.

1 | Haystack Oncology and Université de Montréal's affiliated hospital research centre, the CRCHUM, to Deploy Haystack MRD™ Technology in Research Study for Metastatic Colorectal Cancer New Partnership | Haystack Oncology, University of Montreal

M&A | VC | Private Equity | Legal

Myriad Genetics and Personalis have entered into an agreement to cross-license patent estates covering tumor-informed approaches to detect MRD, providing more freedom to operate and broadening patient access to MRD. Foresight Diagnostics announced the closing of $33 million in new capital, which will be used to support advancement of Foresight CLARITY, the company’s MRD testing platform. The company has raised $86 million in venture financing to date. Biological Dynamics has permanently closed its operations and completed a restructuring, with a new company advancing its platform.  

1 | Myriad Genetics and Personalis Cross-License Foundational MRD Intellectual Property to Broaden Patient Access to Testing Intellectual Property Licensing | Myriad Genetics, Personalis

2 | Foresight Diagnostics Expands Series B Financing to $73.75 Million to Advance the Foresight CLARITY™ MRD Platform Financing Round | Foresight Diagnostics

3 | Biological Dynamics Shutters; Successor Firm to Advance Exosome Platform Closure and Takeover | Biological Dynamics

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Additional Sources

Clinical and Regulatory

1 | AHRQ Releases a Protocol for Blood-Based Tests for Multiple Cancer Screening MCED Protocol | Agency for Healthcare Research and Quality (AHRQ)

M&A | VC | Private Equity | Legal

1 | Cooperating Cancer Testing Company Agrees to Pay Over $900,000 to Resolve Allegations of False Claims for Lab Tests Legal Settlement | Guardant Health