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Highlights & Summary

Liquid Biopsy (LBx) continued to develop through October, featuring new FDA approvals and fundraising.

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Featured DeciBio Insights

1 | Emerging Applications and Platforms in Liquid Biopsy Webinar Recording | DeciBio

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Clinical and Regulatory

The FDA approved FoundationOne Liquid CDx to be used as a companion diagnostic for Itovebi (inavolisib) in combination with palbociclib and fulvestrant for the treatment of PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer, including the first-line setting. The FDA also approved Exact Sciences’ Cologuard Plus test, the next generation multitarget stool DNA test, based on findings from the pivotal BLUE-C study where Cologuard Plus demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity with no findings on colonoscopy. The Cologuard Plus test is now approved for adults ages 45 and older who are average risk for colorectal cancer (CRC).

1 | FDA Approves FoundationOne®Liquid CDx as a Companion Diagnostic for Itovebi™ to Identify Patients with HR-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation FDA CDx Approval | Foundation Medicine

2 | FDA Approves Exact Sciences’ Cologuard Plus™ Test, Setting A New Benchmark in Non-Invasive Colorectal Cancer Screening FDA Approval | Exact Sciences

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Company Announcements & Product Launches

GeneCentric announced the launch of its ExpressCT (Expression Signatures Through Circulating Tumor Signals) liquid biopsy platform that allows RNA expression and epigenomics to assessed in liquid biopsy samples, including blood and urine. InformedDNA and Phenomix announced a collaboration that integrates Phenomix’s saliva-based MyPhenome genetic obesity test with InformedDNA’s DNAimpact precision health platform, broadening access to genetics-based weight management care.  

1 | GeneCentric Therapeutics Launches EXpressCT Liquid Biopsy Platform Product Launch | GeneCentric

2 | InformedDNA partners with Phenomix Sciences to personalize obesity care, treatment and planning based on a patient’s DNA Partnership | InformedDNA, Phenomix Sciences

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Clinical Trials & Study Results  

Myriad Genetics announced five research collaborations studying the use of MRD in various breast cancer settings using Myriad’s Precise MRD test. Research collaborations include predicting treatment response in adjuvant HR-positive patients, potentially guiding surgical decisions in newly diagnosed HR-positive patients, monitoring for recurrence across subtypes, optimizing therapy maintenance in HER2-positive advanced or metastatic patients, and monitoring ctDNA levels in high-risk patients from diagnosis through the adjuvant setting.

1 | Myriad Genetics Announces Five Research Collaborations to Study the Use of MRD Testing in Breast Cancer Research Collaborations | Myriad Genetics

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M&A | VC | Private Equity | Legal

Aitiologic announced over €2.5M in total funding to date, including non-dilutive grants from the Austrian Promotional Bank and the Austrian Research Promotion Agency, which it will use to develop its AI-powered aitios platform for early disease detection and personalized medicine. The company’s liquid biopsy approach combines genetic and epigenetic cfDNA testing with the aitios platform for cloud-based interpretation, intending to enhance NIPT and oncology testing. Xgenera announced over £3m in funding, with investment led by QantX alongside a grant from National Institute for Health and Care Research (NIHR). Xgenera is developing miONCO, a blood-based multi-cancer screening test which measures microRNA expression.

1 | Aitiologic Emerges from Stealth Mode with Over €2.5M to Advance AI-Powered Liquid Biopsy Platform for Early Disease Detection Funding | Aitiologic

2 | Xgenera Announces Major Investment & Partnership Funding | Xgenera

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