Highlights & Summary
Liquid Biopsy (LBx) continued to develop through April, featuring multiple new product launches and partnerships.
Featured DeciBio Insights
1 | ASCO 2025: Schedule a meeting with our team Conference | DeciBio
Clinical and Regulatory
BillionToOne announced that its comprehensive genomic profiling (CGP) assay Northstar Select has received Medicare coverage, effective as of February 14, 2025, for eligible advanced solid tumors. Genomic Testing Cooperative (GTC) announced it received UKCA marks for its Liquid Trace Hematology and Liquid Trace Solid Tumor, which are pan-cancer tests for heme malignancies and solid tumors respectively. The tests evaluate cfDNA and cfRNA and are used for diagnosis, evaluating host immune response, and identifying biomarkers for predicting responses to various therapies. The UKCA mark is a requirement for offering testing in the United Kingdom. Mursla Bio received FDA Breakthrough Device Designation for its EvoLiver test for HCC surveillance in high-risk cirrhotic patients. EvoLiver is a blood test that detects organ-specific extracellular vesicles (EVs) and showed 86% early-stage sensitivity at 88% specificity for liver cancer surveillance. Guardant announced it entered into an agreement with Bayshore HealthCare, a leading home and community healthcare service provider in Canada, to offer Guardant’s portfolio of precision oncology tests through the Bayshore network of clinics in Canada.
1 | BillionToOne Announces Medicare Coverage for Northstar Select® Medicare Coverage | BillionToOne
2 | Genomic Testing Cooperative Receives UKCA Mark for its Portfolio of Hematology, Solid Tumors and Liquid Biopsy Profiles covering DNA and RNA UKCA Mark | Genomic Testing Cooperative (GTC)
3 | Mursla Bio receives FDA Breakthrough Device Designation for EvoLiver™ test FDA Breakthrough Device Designation | Mursla Bio
Company Announcements & Product Launches
Labcorp expanded its portfolio with two solutions: Labcorp Plasma Detect, a tumor-informed MRD assay to help assess the risk of disease recurrence in stage III colon cancer patients, and PGDx elio plasma focus Dx, the first and only kitted pan-solid tumor liquid biopsy test authorized by FDA to identify patients who may benefit from targeted patients. Natera announced its Signatera Genome assay is now broadly available to physicians in the United States, available in CLIA, IUO, and RUO options. OncoHelix announced a partnership with AstraZeneca Canada to deliver liquid biopsy testing for men with metastatic castration-resistant prostate cancer (mCRPC) to guide targeted treatments. Guardant announced a multi-year collaboration with Pfizer to support development and commercialization of Pfizer’s oncology portfolio using the Guardant Infinity smart liquid biopsy platform, including to evaluate the clinical utility of ctDNA level as a surrogate endpoint. AccuStem and EmeritusDX announced an expanded partnership that includes commercialization of the microRNA-based MSC test for lung cancer screening. Precision for Medicine also partnered with SOPHiA GENETICS to expand biopharma services by leveraging SOPHiA DDM platform and providing the MSK-ACCESS liquid biopsy test.
1 | Labcorp Launches Molecular Residual Disease and Liquid Biopsy Solutions Product Launches | Labcorp
2 | Natera Announces Broad Clinical Launch of Ultra-Sensitive Signatera™ Genome MRD Test Clinical Launch | Natera
3 | OncoHelix and AstraZeneca Partner to Provide Access to Liquid Biopsy Testing for Men with Prostate Cancer Partnership | OncoHelix, AstraZeneca
Clinical Trials & Study Results
Personalis announced interim analysis results of the VICTORI study which showed performance of its MRD test NeXT Personal in detecting early signs of residual or recurrent cancer in a cohort of 71 patients with resectable stage I-IV colorectal cancer (CRC). Key findings include 100% of patients who recurred were detected as ctDNA-positive prior to detection on imaging, with 85% of clinical recurrence detectable within 4 weeks after surgery. 64% of detections within the landmark window were under 100 ppm. Additionally, 100% of patients who have been ctDNA-negative throughout the study remain disease-free.
1 | Interim Analysis Results of the VICTORI study of NeXT Personal Interim Analysis Results | Personalis
M&A | VC | Private Equity | Legal
Craif raised $22M in Series C funding which will be used to expand its R&D and testing services in Japan for its miRNA-based early cancer detection platform while building out more of a presence in the United States. Caris Life Sciences has collected $168M in new funding to support the growth of its precision medicine platforms, which can include liquid biopsy tests such as the Caris Assure test launched last year.
1 | Craif Raises US $22 million in Series C Funding, Accelerates U.S. Expansion and R&D Series C Funding | Craif
2 | Caris Life Sciences collects $168M to fund tumor test rollouts New Funding | Caris Life Sciences
Additional Sources
Clinical and Regulatory
1 | Guardant Health and Bayshore HealthCare Partner to Expand Access to Advanced Precision Oncology Testing in Canada Expanded Access | Guardant Health, Bayshore HealthCare
Company Announcements & Product Launches
1 | Guardant Health Announces Strategic Collaboration With Pfizer to Support Development and Commercialization of New Cancer Therapies Using Guardant Infinity Smart Liquid Biopsy Platform Partnership | Guardant Health, Pfizer
2 | AccuStem Sciences, Inc. and EmeritusDX Announce Partnership to Commercialize MSC Test for Lung Cancer Screening Partnership | AccuStem Sciences, EmeritusDX
3 | Precision for Medicine Partners with SOPHiA GENETICS to Expand Biopharma Services with the SOPHiA DDM™ Platform and its Liquid Biopsy Capabilities Partnership | Precision for Medicine, SOPHiA GENETICS
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