Highlights & Summary
Liquid Biopsy (LBx) continued to develop through July, featuring new clinical and research collaborations as well as trial launches and study results.
Featured DeciBio Insights
1 | New Newsletter: Precision Medicine in Europe: Policy and Approvals
2 | New Newsletter: Investing in Precision Medicine: VC | PE | M&A
3 | DeciBio Pharma Services Market Report
4 | DeciBio Oncology Genomics Tracker
5 | Breaking Boundaries with AI in Digital Pathology: A Q&A with Jill Stefanelli, CEO of Modella AI
Clinical and Regulatory
SAGA Diagnostics has received Medicare coverage for its Pathlight MRD test in stages II and III of all breast cancer subtypes. SAGA’s assay, built on WGS and dPCR, demonstrated 100% sensitivity, 100% specificity and a 13.7-month lead time versus standard-of-care recurrence testing. ClearNote Health received UK Conformity Assessed (UKCA) marking for its Avantect Pancreatic Cancer test, an early detection test using genomic and epigenomic data. The mark, part of the UK’s safety regulatory framework, denotes compliance with UK medical device regulations, and clears the path for commercialization. Exact Sciences also announced a Medicare coverage decision in July. Exact’s Oncodetect MRD test received coverage for serial use in stage II, III and resectable stage IV colorectal cancer in the adjuvant and recurrence monitoring settings over a 5-year period. The test tracks up to 200 ctDNA variants to provide earlier detection of cancer recurrence.
1 | SAGA Diagnostics Announces Medicare Coverage for Pathlight MRD Test in Breast Cancer Across All Subtypes Medicare Coverage | SAGA Diagnostics
2 | ClearNote Health Receives First In Vitro Diagnostic Approval for Its Avantect Pancreatic Cancer Test UKCA Clearance | ClearNote Health
3 | Exact Sciences Announces Medicare Coverage for Oncodetect™ Molecular Residual Disease Test in Colorectal Cancer Medicare Coverage | Exact Sciences
Company Announcements & Product Launches
VieCure announced the expansion of its precision oncology ecosystem through a partnership with Guardant Health. Guardant’s assays will be integrated into VieCure’s Halo Intelligence platform, enabling oncologists using VieCure’s platform to order tests within their clinical workflows, and eliminating manual processes. Future phases will expand analytical integrations. Mirxes Japan and Nagawa Pharmaceutical have partnered for a nationwide public health initiative focused on the early detection of gastric cancer. The effort, launched by former Prime Minister of Japan Yukio Hatoyama, will make screening using Mirxes’ GASTROClear microRNA blood test available to up to 10,000 residents across Japan. It is part of a broader collaboration which will also employ Mirxes’ LUNGClear, with Nagawa supporting test localisation, manufacturing, and distribution. Personalis and Tempus have expanded and extended their strategic collaboration. Personalis’ NeXT Personal ultra-sensitive MRD test will now be available through Tempus for CRC recurrence testing (in addition to breast and lung recurrence monitoring, and solid tumor immunotherapy monitoring). Tempus will remain Personalis’ exclusive commercial partner through 2028.
1 | VieCure Expands Precision Oncology Ecosystem Through Strategic Partnership with Guardant Health Platform Integration | VieCure, Guardant Health
2 | Japan launches nationwide initiative to promote gastric health and early detection of gastric cancer, Co-initiated by Mirxes Japan & Nagawa Screening Initiative & Partnership | Mirxes Japan, Nagawa Pharmaceutical
3 | Personalis Expands Tempus Strategic Collaboration to Bring Ultra-Sensitive Cancer Recurrence Testing to Colorectal Cancer Patients Partnership Expansion | Personalis, Tempus
Clinical Trials & Study Results
Caris Life Sciences has published results showing performance of its AI-enabled WES / WTS Assure assay in EDx, MRD, disease monitoring, and therapy selection applications. It diagnosed cancers early with 83.1% to 95.7% sensitivity (varying by stage) and 99.6% specificity, showed high concordance with tissue for driver mutation identification (PPA of 93.8%, PPV of 96.8%), and demonstrated value in predicting disease free survival in MRD / monitoring applications. Natera launched its Phase II TEODOR trial. The study will use Signatera negativity to de-escalate neoadjuvant therapy, from chemotherapy to endocrine therapy, in HR+, HER2- breast cancer patients. Guardant Health published the first readout from their RADIOHEAD study, in collaboration with the Parker Institute for Cancer Immunotherapy. The analysis found that Guardant Reveal detected responses in immunotherapy across multiple types of advanced solid tumors and identified non-responders from roughly 3 to 5 months before standard methods.
1 | Validation of an AI-Enabled Exome / Transcriptome Liquid Biopsy Platform for Early Detection, MRD, Disease Monitoring, and Therapy Selection for Solid Tumors Study Results | Caris Life Sciences
2 | Natera Announces Launch of ABCSG 61 (“TEODOR”), a Randomized Controlled Trial of Signatera™ in Early-Stage Breast Cancer Trial Launch | Natera
3 | New RADIOHEAD Study Validates Use of Guardant Reveal Tissue-Free Monitoring for Earlier Detection of Immunotherapy Response in Advanced Cancer Study Readout | Guardant Health
M&A | VC | Private Equity | Legal
Aqtual has raised $31m in its oversubscribed Series B fundraising round. Aqtual is using a novel active chromatin cfDNA platform to develop products, including its flagship therapy response prediction test in rheumatoid arthritis (RA). PRIMA-102, a prospective observational trial in RA, is actively enrolling and is expected to be complete by the end of the year. Circular Genomics received $250k from the Alzheimer’s Drug Discovery Foundation’s Diagnostic Accelerator program. The funds will be used to further Circular Genomics study of circRNA blood biomarkers for diagnosing and predicting progression in AD.
1 | Aqtual Raises Over $30M as It Scales Novel cfDNA Platform Funding | Aqtual
2 | Circular Genomics Receives $250K Investment from the Alzheimer's Drug Discovery Foundation (ADDF) to Advance First-in-Class Circular RNA Blood-Based Biomarker Tests for the Early Detection of AD Funding | Circular Genomics, Alzheimer’s Drug Discovery Foundation, Washington University St. Louis
Additional Sources
Company Announcements & Product Launches
1 | UCLA School of Dentistry and Dongwoon Anatech Launch Collaboration to Advance Saliva-Based Cancer Detection Technology Collaboration | Dongwoon Anatech, UCLA School of Dentistry
Clinical Trials & Study Results
1 | First Patient Enrolled in National Cancer Institute’s Vanguard Study Evaluating Guardant Health’s Shield Multi-Cancer Detection Test First Patient Enrollment | Guardant Health, NCI
2 | Spatiotemporal T-cell tracking for personalized T-cell receptor T-cell therapy designs in childhood cancer Study Results | Omniscope, Centro Nacional de Análisis Genómico, IRB Barcelona, Sant Joan de Déu Hospital
3 | Modifications of Microbiome-Derived Cell-Free RNA in Plasma Discriminates Colorectal Cancer Samples Study Results | University of Chicago
