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Highlights & Summary

Liquid Biopsy (LBx) continued to develop through March, featuring new coverage decisions and clinical trial launches and updates.

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Featured DeciBio Insights  

1 | AGBT 2025: DeciBio Highlights – NGS (and Roche) Reclaims the Spotlight Conference Survey | DeciBio

2 | Katie Maloney Recognized in the Top 25 Women Leaders in Consulting for 2025 Award | The Consulting Report, DeciBio

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Clinical and Regulatory

Guardant Health made two announcements related to reimbursement. First, the Centers for Medicare & Medicaid Services (CMS) approved Advanced Diagnostic Laboratory Test (ADLT) status for their Shield test. Second, the US Department of Veterans Affairs (VA) Community Care Network (CCN) has also granted coverage for the test. Guardant Shield is a blood test used for primary colorectal cancer screening in average risk individuals 45 years or older; it was approved by the FDA in July 2024.

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1 | Guardant Health Receives ADLT Status From CMS for Shield Blood Test CMS ADLT Designation | Guardant Health

2 | Guardant Health’s Shield Blood Test Now Covered for VA Community Care Beneficiaries  Coverage Decision | Guardant Health

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Company Announcements & Product Launches

At the European Association of Urology Congress, the BRECISE consortium awarded Novigenix a grant of 1.8M euros. The grant, funded by the European Union, will further Novigenix’s mission of developing and making accessible AI-powered LBx solutions. Tethis S.p.A. and Israel’s Sheba Medical Center announced a research collaboration which will serve to evaluate Tethis’ See.d instruments, to be installed at Sheba’s Institute of Pathology, and the utility of CTC plus ctDNA monitoring for prediction of relapse in rectal cancer patients. Samples will be collected before and after neoadjuvant therapy. City University of Hong Kong, in partnership with Cellomics, has announced a project aimed at the development of CTC detection technology. Hong Kong’s governmental RAISe+ scheme is contributing funding to the project.

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1 | Novigenix awarded EUR 1.8M in the groundbreaking BRECISE IHI Consortium to industrialize AI-powered liquid biopsy for prediction of immunotherapy response Research Grant | Novigenix, EU BRECISE Consortium, European Association of Urology Congress

2 | Tethis S.p.A. collaborates with Sheba Medical Center to advance AI-powered liquid biopsy in rectal cancer Collaboration | Tethis S.p.A., Sheba Medical Center

3 | CityUHK leads groundbreaking project to develop new platform for early cancer detection Collaboration | City University Hong Kong, Cellomics

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Clinical Trials & Study Results

Veracyte announced data from its TOMBOLA trial, a large, independent, multicenter interventional trial, in an oral presentation at the Annual European Association of Urology Congress (abstract A0162). Veracyte states that the data show that its WGS-based MRD platform outperformed ddPCR-based blood testing and standard imaging in detecting muscle-invasive bladder cancer treated with neoadjuvant chemotherapy and radical cystectomy. Foresight Diagnostics has launched the PRECISE-HL clinical trial in partnership with the University of Washington and Fred Hutch to evaluate whether chemotherapy can be safely reduced in advanced-stage classical Hodgkin lymphoma (cHL) patients who show early response, using its ultra-sensitive ctDNA-based MRD test, CLARITY™. The trial will stratify treatment based on interim ctDNA results after two cycles of nivolumab + AVD therapy, aiming to personalize therapy while maintaining efficacy and reducing long-term side effects. Natera announced the enrollment of the first patients in the HEROES phase II clinical trial, which evaluates ctDNA-guided discontinuation or de-escalation of anti-HER2 therapy in metastatic HER2+ breast cancer. The study will monitor Signatera-negative patients who stop treatment to assess 1-year progression-free survival, ctDNA dynamics, and quality-of-life, while Signatera-positive patients will continue standard maintenance therapy.

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1 | New Data Demonstrate Accuracy of Veracyte’s Whole-Genome Sequencing-Based MRD Testing Platform for Muscle-Invasive Bladder Cancer Trial Data | Veracyte

2 | Foresight Diagnostics Launches PRECISE-HL Trial to Explore ctDNA-Based Therapy De-Escalation in Classical Hodgkin Lymphoma (cHL) Trial Launch | Foresight Diagnostics

3 | Natera Announces Enrollment of First Patients in the HEROES Clinical Trial in Metastatic HER2+ Breast Cancer Trial Initiation | Natera

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M&A | VC | Private Equity | Legal  

Mainz Biomed has entered an exclusive licensing agreement with Liquid Biosciences to develop a blood-based pancreatic cancer screening test using a newly discovered panel of mRNA biomarkers, which demonstrated 95% sensitivity and 98% specificity across multiple independent cohorts. The test will be developed using Liquid’s EMERGE platform and proprietary algorithm, with plans for commercial assay refinement, algorithm enhancement, and potential FDA application. Advanced Biomed Inc., which has a microfluidic platform for early cancer detection, announced the closing of its $6.56 million initial public offering, selling 1,640,000 shares at $4.00 each, with shares now trading on Nasdaq under the ticker “ADVB.” Aditxt’s subsidiary Pearsanta has acquired patents for adductomics-based DNA damage detection technology in a $1 million stock transaction, aiming to integrate it into early cancer risk assessment tools. Over the next 2–3 years, Pearsanta plans to clinically validate and commercialize this platform—which detects DNA damage from carcinogens before mutations occur—complementing its existing Mitomic® Technology and expanding its precision oncology portfolio toward proactive, non-invasive cancer prevention.

1 | Mainz Biomed and Liquid Biosciences Make Groundbreaking Discovery of mRNA Biomarkers for Blood Based Detection of Pancreatic Cancer Use Agreement | Mainz Biomed, Liquid Biosciences

2 | Advanced Biomed Inc. Announces Closing Of US$6.56 Million Initial Public Offering IPO | Advanced Biomed Inc.

3 | Aditxt Subsidiary Pearsanta Completes the Acquisition of Proprietary Adductomics Technology to Develop and Advance the Platform Toward Clinical and Commercial Applications for Monitoring Early Signs of Increased Cancer Risk Acquisition | Aditxt, Pearsanta

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Additional Sources

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Clinical Trials & Study Results

1 | Mainz Biomed Enrolls First Patient in Its eAArly DETECT 2 Clinical Study Trial Initiation | Mainz Biomed

2 | LifeTracDx Blood Test to be Performed in Key Colorectal Clinical Trial Trial Collaboration | Creatv Bio, CytoDyn Therapeutics

3 | Routine Clinical Liquid Biopsy Testing for Solid Tumors Delivers the Promise of Minimally Invasive Detection of Genomic Variants With a Faster Turnaround Time Study Results | MD Anderson Cancer Center

4 | Fragmentomics profiling and quantification of plasma Epstein-Barr virus DNA enhance prediction of future nasopharyngeal carcinoma Study Results | Centre for Novostics, The Chinese University of Hong Kong