Highlights & Summary
Liquid Biopsy (LBx) continued to advance in June, featuring guideline and reimbursement news, collaborations and product launches, and numerous study results and trial announcements.
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Clinical and Regulatory
The NCCN has updated its Guidelines for Colorectal Cancer Screening. The revised guidelines now include Guardant’s Shield and Geneoscopy’s ColoSense tests, both of which are noninvasive tests (using blood in Shield’s case, and stool in ColoSense’s) with FDA approval for screening in adults over 45 years old at average risk for CRC. On the prostate screening front, the NCCN also added two new LBx methods to its guidelines, in this case for distinguishing high-grade cancer. The latest guidelines include Stockholm3 from A3P Biomedical, a blood test using blood-based protein biomarkers and SNPs, and MyProstateScore 2.0 from Lynx Dx which measures biomarkers from a urine sample. These tests are the latest in a growing list recommended by the NCCN for improving diagnostic precision. Natera also took a step this month toward broader adoption of its Signatera Genome MRD assay, which received Medicare coverage for several indications. This decision matches existing coverage for the earlier exome-based version of Signatera.
1 | NCCN Adds Geneoscopy and Guardant Health Molecular Tests to CRC Screening Guideline Guideline Update | Guardant Health, Geneoscopy, NCCN
2 | NCCN Adds Stockholm3, MyProstateScore to Prostate Cancer Early Detection Guidelines Guideline Update | A3P Biomedical, Lynx Dx
3 | Natera Announces Medicare Coverage for Signatera Genome Medicare Coverage | Natera
Company Announcements & Product Launches
Foresight Diagnostics and QIAGEN have announced a strategic partnership. Through their global collaboration, the two companies will develop and commercialize a kit-based version of Foresight’s CLARITY MRD assay for lymphoma, enabling decentralized testing. Alamar Biosciences has partnered with the Alzheimer’s Disease Data Initiative and Gates Ventures to generate what will be one of the largest proteomic datasets linked to clinical outcomes in Alzheimer’s. Research centers in the US, Sweden, UK and India will use Alamar’s NULISAseq CNS Disease and Inflammation panels to profile over 40,000 plasma samples to facilitate biomarker discovery and further understanding of Alzheimer’s progression and treatment. SAGA Diagnostics launched its multi-cancer MRD platform, called Pathlight, in the US. The test has been submitted to MolDX for reimbursement, and is initially indicated for use in breast cancer. It uses whole genome sequencing to identify structural variants.
1 | Foresight Diagnostics and QIAGEN Announce Strategic Partnership to Advance Development of Companion Diagnostic Kits for Lymphoma Partnership | Foresight Diagnostics, QIAGEN
2 | Alamar Biosciences, Alzheimer’s Disease Data Initiative, and Gates Ventures Unite in Global Partnership to Advance Translational Research in Alzheimer’s Disease Partnership | Alamar Biosciences, Alzheimer’s Disease Data Initiative, Gates Ventures
3 | SAGA Diagnostics Launches Multi-cancer MRD Platform in US Product Launch | SAGA Diagnostics
Clinical Trials & Study Results
Personalis presented new data from its PREDICT DNA and SCANDARE studies showing the performance of its ultrasensitive NeXT Personal MRD assay in triple negative breast cancer. CtDNA positivity after neoadjuvant therapy was highly prognostic of relapse-free survival and predicted relapse better than pathologic complete response. Results also suggest value for post-surgical ctDNA testing, and ultrasensitive detection (<100 PPM). GRAIL announced top-line results from its PATHFINDER 2 study. Compared to the previous PATHFINDER study, results for the first 25,578 patients (of 35,878 adults over 50) of PATHFINDER 2 showed substantially improved positive predictive value (vs 43%), and consistent cancer signal origin accuracy and specificity (88% and 99.5% in PATHFINDER, respectively). Performance details for PATHFINDER 2 have not been published but are expected by year end. GRAIL is in the process of submitting PMA modules to the FDA and expects to finish in H1 2026. ClearNote Health’s Avantect Pancreatic Cancer Test, a screening assay, will begin its trial in the UK. Patient enrollment began on June 16 for the SAFE-D study which will include up to 15,000 patients. See the full newsletter for additional sources—there were numerous significant publications this month in LBx.
1 | New Data Shows NeXT Personal Identifies Breast Cancer Patients Receiving Neoadjuvant Therapy that are at High Risk for Relapse Study Results | Personalis
2 | GRAIL Announces Positive Top-Line Results From The Galleri PATHFINDER 2 Registrational Study Study Data | GRAIL
3 | ClearNote Health Avantect® Pancreatic Cancer Test Enters Patient Enrollment Phase of Groundbreaking UK Study Targeting High-Risk Patients Trial Launch | ClearNote Health
M&A | VC | Private Equity | Legal
GeneCentric Therapeutics, a company focused on incorporating gene expression profiling into liquid biopsy, closed its Series C financing, having raised $8 million. The funds will go towards the launch and commercialization of the company’s GenomicsNext, a platform that provides both expression measurements for thousands of genes and detection of variants from ctDNA. OrisDX, a University of Chicago spinout, raised $4 million in seed financing. The round will fund the launch of OrisDX’s saliva-based multiomic platform, initially aimed at oral cancer early detection. Nanostics, a Canadian diagnostics company, received $2.8 million in a grant from Genome Canada and Genome Alberta to drive adoption of its ClarityDx Prostate test. ClarityDx Prostate uses machine learning to assess prostate-specific antigen and extracellular vesicles from blood, providing a cancer risk assessment. Funds will be applied to clinical study and other data generation supporting the test’s adoption in Canada, with partnerships for US and Middle East commercialization already in place.
1 | GeneCentric Announces Series C Financing to Advance Novel Liquid Biopsy Platform for Precision Oncology Fundraising | GeneCentric
2 | OrisDX Raises $4M Seed to Launch First-of-Its-Kind Saliva-Based Multiomic Platform, Targeting Oral Cancer Fundraising | OrisDX
3 | Nanostics Gets C$3.8M Grant to Boost Adoption of Prostate Cancer Test Grant | Nanostics, Genome Canada, Genome Alberta
Additional Sources
Company Announcements & Product Launches
1 | Tempus Introduces xM, An Assay to Monitor Immunotherapy Response for Patients with Advanced Cancers Product Launch | Tempus
2 | Plus Therapeutics to launch CNS cancer diagnostic platform in 2025 Product Relaunch | Plus Therapeutics
3 | Gene Solutions Strengthens China Footprint with Strategic Partnerships in Precision Oncology Partnership | Gene Solutions, ZaoDx, MagicBiotech
4 | Gene Solutions and Topgen Join Forces to Advance Precision Oncology All Over China Partnership | Gene Solutions, Topgen
5 | Oncocyte Changes Name to Insight Molecular Diagnostics Inc. (iMDx), Moves Headquarters to Nashville Rebranding & Relocation | Insight Molecular Diagnostics (formerly Oncocyte)
Clinical Trials & Study Results
1 | Clinical Validation of a Circulating Tumor DNA–Based Blood Test to Screen for Colorectal Cancer Study Results | Freenome
2 | Personalis’ NeXT Personal® Predicts Cervical Cancer Recurrence Risk in New CALLA Phase 3 Study Analysis Presented at ASCO Study Results | Personalis
3 | Exact Sciences Announces Expanded Clinical Validation of the Oncodetect™ Test and Molecular Residual Disease Innovation Roadmap Study Data | Exact Sciences
4 | Harbinger Health Showcases Multi-Cancer Early Detection Performance in High-Risk Populations at ASCO 2025 Study Data | Harbinger Health
5 | Initial Results from the DART Study Indicate that Medicover Genetics’ MRD Test can Detect Minimal Residual Disease in Lung Cancer Patients Study Data | Medicover Genetics
6 | Performance Evaluation of a Multi-cancer Early Detection Assay Using NMR-Based Molecular Signatures in a Multi-Center Study Study Data | Wholomics
7 | Circulating Cell-free DNA Methylation Patterns Indicate Cellular Sources of Allograft Injury After Liver Transplant Study Results | Georgetown University
M&A | VC | Private Equity | Legal
1 | Caris Life Raises $494 Million in US IPO Initial Public Offering | Caris Life Sciences
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