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Highlights & Summary

Liquid Biopsy (LBx) continued to develop through May, featuring new clinical and research collaborations as well as trial launches and study results.

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Featured DeciBio Insights  

1 | BIO 2025: Schedule a meeting with our team Conference | DeciBio

2 | First Edition of DeciBio's Pharma R&D Services Market Report Coming Soon! Market Reports| DeciBio

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Clinical and Regulatory

Inocras announced that their minimal residual disease platform, MRDVision, received CLIA validation and is ready for clinical use, following favorable results in a comparison with a competing assay. MRDVision has a simulated limit of detection of 1 ppm, and was developed by combining Inocras’ CancerVision WGS platform and Ultima Genomics’ ppmSeq technology. By following a tumor whole genome-informed, whole genome-cfDNA monitoring approach, Inocras has eliminated the need for patient-specific panel development. GRAIL and athenahealth announced a partnership aimed at giving healthcare providers easier access to Galleri MCED ordering. Galleri will be orderable through athenaOne, the company’s electronic health record solution.  

1 | Inocras Unveils New MRDVision Data and CLIA Validation CLIA Validation | Inocras

2 | GRAIL and athenahealth Team Up to Offer Healthcare Providers Streamlined Ordering of GRAIL’s Galleri® Multi-Cancer Early Detection (MCED) Test EHR Integration | Grail, Athenahealth

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Company Announcements & Product Launches

Guardant Health has launched the Guardant Hereditary Cancer test. The germline test identifies inherited cancer predisposition by analyzing genetic variants associated with risk. 82 genes are included in the blood-based assay, which relate to elevated risk for more than 12 tumor types. Geneseeq announced the development of a pancreatic cancer EDx assay, and published associated data. The assay analyzes cfDNA fragmentomics using machine learning and AI, and achieved sensitivity of up to 97.3% and specificity of 95.2% (maximum values across training and validation cohorts). Summit Health has established a new NGS service at their laboratory in New Jersey through the internalization of Genomic Testing Cooperative’s DNA and RNA profiling tests.  

1 | Guardant Health Introduces Hereditary Cancer Testing to Identify Inherited Predispositions to Certain Types of Cancer Product Launch | Guardant Health

2 | Geneseeq Unveils Groundbreaking Blood Test for Early Detection of Pancreatic Cancer Product Launch | Geneseeq

3 | Summit Health Announces Internalization of GTC’s DNA & RNA Profiling Tests
Service Expansion | Summit Health, Genomic Testing Cooperative

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Clinical Trials & Study Results

Results from Geneseeq’s large MCED study, named DECIPHER-Omnia, were published in Nature Medicine. The study of Geneseeq’s CanScan assay, an AI-driven WGS assay integrating fragmentomic, genomic and epigenomic data to screen for more than 12 cancers at a time, included over 8,000 participants, with a larger cohort study of 15,000 currently underway. The American Journal of Transplantation published a study of Natera’s Prospera Heart assay. Prospera is used to assess the risk of allograft rejection; the updated assay improved from 78.2% to 86.5% sensitivity, and 76.9% to 83.6% specificity. Grail has published new research assessing the value of MCED use, and the relative benefit of different screening intervals. Annual screening was most beneficial, though biennial screening was more efficient per 100,000 tests in preventing deaths within 5 years.

1 | Geneseeq’s Breakthrough Cancer Detection Blood Test Published in Nature Medicine Study Results | Geneseeq

2 | Prospera™ Heart Test with DQS Outperforms dd-cfDNA Percentage in Detecting Allograft Rejection, New AJT Publication Shows Study Results | Natera

3 | New Grail Publication Explores Optimal Liquid Biopsy MCED Test Interval for Mortality Impact New Publication | Grail

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M&A | VC | Private Equity | Legal

Phase Scientific announced their Series A fundraising of $34 million. The Hong Kong-based company is working to develop and commercialize urine-based LBx technology using its Phasify technology. Phase’s HPV assay has delivered promising results to-date; the fundraising was lead by a PE fund managed by Value Partners Group. QCDx has raised $7 million in new financing to support their CTC detection and characterization technology. The company is planning the completion of a breast cancer clinical validation study in partnership with UCONN Health, and the relocation of its CLIA lab this year. Hedera Dx has secured $15 million in funding of its own, in a Series A round led by Vsquared Ventures. Hedera leverages LBx with the aim of eliminating barriers to targeted cancer therapy. Oslo University Hospital has received $15.3 million from a EU grant for the PRED-LYNCH (Prediction in Lynch Syndrome) effort, which seeks to develop LBx tests for individuals with Lynch syndrome.

1 | Phase Scientific Raises $34M in Series A Financing for Urine Liquid Biopsy Fundraising | Phase Scientific

2 | QCDx: $7 Million Raised For Advancing Liquid Biopsy Innovations Fund Raising | QCDx

3 | Hedera Dx Secures €15 Million Series A to bring modern cancer care to patients across the globe Series A | Hedera Dx

4 | Oslo University Hospital Gets €13.6M to Develop Liquid Biopsies for Lynch Syndrome Cancers Research Grant | Oslo University Hospital

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Additional Sources

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Company Announcements & Product Launches

1 | Ultima Genomics Makes Inroads in Blood-Based MRD Testing Product Development | Ultima Genomics

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Clinical Trials & Study Results

1 | Somatic Tumor Next-Generation Sequencing in US Veterans With Metastatic Prostate Cancer Retrospective Analysis | Moffitt Cancer Center

2 | Direct Comparison of Alternative Blood-Based Approaches for Early Detection and Diagnosis of HPV-Associated Head and Neck Cancers Methodology Comparison | Mass General Brigham

3 | Genome-Wide Analyses of Cell-Free DNA for Therapeutic Monitoring of Patients with  Pancreatic Cancer Novel Tx Monitoring Assay | Johns Hopkins University

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M&A | VC | Private Equity | Legal

1 | MiRxes Launches HK$880.5M IPO on Hong Kong Stock Exchange Initial Public Offering | MiRxes

2 | Mainz Biomed Announces Pricing of $4.0 Million Follow-On Offering of Ordinary Shares and Warrants Share Pricing | Mainz Biomed

3 | Caris Life Sciences Files Registration Statement for Proposed Initial Public Offering Initial Public Offering | Caris Life Sciences

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