Highlights & Summary
Liquid Biopsy (LBx) continued to progress in August, featuring positive FDA and Medicare decisions, product launches, study results, and funding.
Clinical and Regulatory
Freenome received FDA Breakthrough Device Designation for SimpleScreen Lung, an investigational multiomic blood test designed to detect early lung cancer signals in adults 50-80 who have at least a 20 pack-year smoking history, paving the way for the test to receive prioritized review during the premarket submission process.
Breakthrough Device Designation | Freenome
2 | NeoGenomics Receives Medicare Coverage for RaDaR ST for Immunotherapy Treatment Response Monitoring
NeoGenomics announced that its RaDaR ST MRD test has received expanded coverage from CMS's MolDx program. Medicare coverage for the test now includes response monitoring for patients with late-stage solid tumors who are being treated with immune-checkpoint inhibitor therapy.
Medicare Coverage Expansion | NeoGenomics
Natera submitted its Signatera tumor-informed MRD assay to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) as a CDx in MIBC, supported by data from the randomized Phase 3 IMvigor011 trial, advancing Natera’s presence to another major regulatory geography.
Regulatory Submission | Natera
Company Announcements & Product Launches
SOPHiA GENETICS announced a multi-year global collaboration with AstraZeneca to develop and deploy two CDx programs: developing its Solid Tumor application into a decentralized CDx and validating its Hematological Oncology application to support a blood cancer CDx.
Collaboration | SOPHiA Genetics, AstraZeneca
2 | BillionToOne Launches Northstar Origin, a New Liquid Biopsy Test to Help Identify Tissue of Origin
BillionToOne launched Northstar Origin, a physician-ordered cfDNA add-on to Northstar Select that predicts tissue of origin for patients with cancer of unknown primary or uncertain diagnosis, combining methylation profiling with tissue-specific somatic variants.
Product Launch | BillionToOne
Natera and Susan G. Komen, a leading breast cancer organization, announced a national partnership to advance breast cancer awareness and education, including efforts to increase understanding of MRD, with Natera serving as 2026 Premier National Series Sponsor of the Race for the Cure and MORE THAN PINK Walk events.
Partnership | Natera, Susan G. Komen
Clinical Trials & Study Results
A study published in Journal of Molecular Diagnostics evaluated Veracyte's whole-genome, tumor-informed MRD approach (the TrueMRD platform), which uses whole-genome sequencing of tumor and matched normal DNA to build a personalized mutational signature for ultrasensitive quantification of ctDNA in plasma. The study demonstrated earlier detection of recurrence in low-stage (including stage IA) lung adenocarcinoma, a setting where tumor fraction is often at the parts-per-million level.
Study Results | Veracyte
A large prospective NIPT study published in American Journal of Obstetrics and Gynecology by BillionToOne showed that its Unity Fetal Risk Screen delivers high sensitivity, specificity, and negative predictive value for recessive conditions, supporting single molecule cfDNA quantification as a reliable primary fetal risk assessment in general-risk pregnancies.
Study Results | BillionToOne
Natera announced a collaboration with Kupando Therapeutics, which will see the use of Natera's Latitude tissue-free MRD assay used for treatment response monitoring in Kupando's Phase 1 trial of its immunotherapy drug, KUP-101, in patients with advanced skin cancers.
Trial Collaboration | Natera, Kupando Therapeutics
M&A | VC | Private Equity | Legal
1| U.S. Court Orders Guardant to Pay $245 Million in DNA Sequencing Patent Dispute
Guardant Health has been ordered by the U.S. District Court for the District of Delaware to pay $245.2M to TwinStrand Biosciences and the University of Washington. The decision marks the final judgment of a patent dispute brought by TwinStrand, alleging infringement of DNA sequencing technology. Guardant stated that it intends to appeal the decision.
Patent Dispute | Guardant Health, TwinStrand Biosciences
2| Craif Raises $33M to Accelerate Introduction of Its Urine-Based Cancer Test to the U.S.
Craif, a Japanese AI and biotech company, has raised $33M in its Series D round, bringing total capital raised to $88M. The company is developing a urine-based platform for the early detection of diseases, including cancer. The proceeds of the funding round will support R&D, launch of its test in the U.S., and Japanese regulatory filings.
Fundraising | Craif
3 | Zepto Life Technology Wins $8.9M NIH Contract for Fungal Infection Panel
Zepto Life Technology has been awarded a contract of up to $8.9M from the US National Institutes of Health’s National Institute of Allergy and Infectious Diseases. The funding will support the advancement of Zepto’s molecular diagnostic system for invasive fungal infections; Minnesota-based Zepto’s lead product, which received FDA BDD in June, aids in mold infection though fungal cfDNA, bypassing the need for culturing.
Funding | Zepto Life Technology, NIH NIAID
Additional Sources
Clinical and Regulatory
PMA Application | GRAIL
Company Announcements & Product Launches
Product Launch | Tagomics
Trial Collaboration | Natera, Angiex
Collaboration | Pillar Biosceicnes, LC-SCRUM-Asia, LSI Medience Corporation
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