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Highlights & Summary

May was a productive month for Liquid Biopsy (LBx). In particular, there were a number of notable clinical and regulatory updates.

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Featured DeciBio Insights

1 | Executive Roundtable: Navigating the FDA's Laboratory Developed Tests Regulation Webinar Webinar | DeciBio

2 | Jason Foster on Ori Biotech and the Path to Viability Q&A | Ori Biotech

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Clinical and Regulatory

Guardant's blood test for colon cancer screening, Shield, received recommendation from the FDA Medical Devices Advisory Committee, paving the way for potential approval. The committee acknowledged both safety and effectiveness of Shield as a primary non-invasive screening option for average-risk adults aged 45 and older. The UK NHS will not be accelerating implementation of Grail's Galleri multi-cancer early detection test based on a review of data from the first year of their ongoing clinical study, finding the data insufficient to justify a large-scale pilot program at this time. The NHS will defer a decision on nationwide Galleri implementation until the full study concludes in 2026. Guardant Health's Guardant360 CDx blood test received IVDR certification in the EU for tumor mutation profiling in solid cancers and identifying patients eligible for specific targeted therapies in lung and breast cancer, potentially improving access to personalized cancer treatment in the EU. Mercy BioAnalytics received an FDA Breakthrough Device Designation for it’s Halo Ovarian Cancer Screening Test in asymptomatic, postmenopausal women. The test analyzes extracellular vesicles, and in data presented at ASCO, outperformed CA125 testing in sensitivity to high-grade serous ovarian cancer, and test specificity in a trial of over 1,300 samples. In Japan, Chugai Pharmaceuticals announced approval from the Ministry of Health, Labour and Welfare for FoundationOne Liquid CDx to be used in the detection of copy number alterations (CNAs) and blood-based tumor mutational burden (TMB). Please refer to the Additional Sources section below for headlines relating to Mercy Bioanalytics, and Chugai Pharmaceutical / FoundationOne.

1 | Guardant’s CRC Screening Test Receives Advisory Committee Recommendation FDA Recommendation | Guardant Health, FDA

2 | UK NHS Declines to Accelerate Grail Galleri Implementation Following Early Data Review EDx Implementation Decision | Grail, NHS

3 | Guardant Health Receives EU IVDR Certification for Guardant360(R) CDx Liquid Biopsy for Tumor Mutation Profiling Across All Solid Cacners and Companion Diagnostic Indications IVDR Certification | Guardant Health  

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Company Announcements & Product Launches

Angle, a UK liquid biopsy company, partnered with AstraZeneca to develop a CTC-based Androgen Receptor assay for prostate cancer studies, with potential to become a revenue stream for Angle as it helps assess new cancer drugs. OSF HealthCare is partnering with DELFI Diagnostics to use DELFI's blood test, FirstLook Lung, to improve lung cancer screening rates. This collaboration aims to increase patient access to lung cancer screening with a non-invasive blood test for early cancer detection. Oxford BioDynamics is partnering with King's College London to develop a blood test using Oxford's EpiSwitch platform to identify people at high risk of developing rheumatoid arthritis following the successful APIPPRA trial.

1 | Angle Signs AstraZeneca Deal to Develop Prostate Cancer Assay Supplier Agreement | ANGLE, AstraZeneca

2 | OSF HealthCare and DELFI Diagnostics Announce Collaboration to Improve Lung Cancer Screening Rates Partnership | OSF HealthCare, DELFI Diagnostics  

3 | Oxford BioDynamics Teams Up With King’s College in Bid to Boost Rheumatoid Arthritis Prevention Biomarker Development Collaboration | Oxford BioDynamics, King’s College London

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Clinical Trials & Study Results

In a study published in The Journal of Heart and Lung Transplantation, sponsored by CareDx, the combination of gene expression profiling (GEP) and donor-derived cell-free DNA (dd-cfDNA) analysis was found to be a better indicator of acute cellular rejection following heart transplantation, compared to the use of either test on its own. Researchers from BostonGene developed a framework for immunoprofiling based on flow cytometry from a blood sample. The test evaluates patients’ immune systems, classifying them into one of five clusters, or immunotypes, from cell type distributions and gene expression patterns; these immunotypes can be associated with therapy responses, and may ultimately be useful in informing treatment decisions.

1 | Surveillance with Dual Non-Invasive Testing for Acute Cellular Rejection After Heart Transplantation: Outcomes from the Surveillance HeartCare Outcomes Registry (SHORE) Study Results | CareDx

2 | Comprehensive Peripheral Blood Immunoprofiling Reveals Five Immunotypes with Immunotherapy Response Characteristics in Patients with Cancer Immuno-Profiling Methodology | BostonGene

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M&A | VC | Private Equity | Legal

Phenomix Sciences, spun out of Mayo Clinic, closed a $5.5 M Series A funding round to advance their blood test, MyPhenome, aimed at identifying obesity phenotypes to personalize weight loss treatment approaches. This test will be validated in a clinical trial funded by a $2.3 M NIH grant.

1 | Phenomix Sciences Closes $5.5M Series A Round, Gets $2.3M NIH Grant Fundraising, NIH Grant | Phenomix  

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Additional Sources

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Clinical and Regulatory

1 | Mercy BioAnalytics Receives Breakthrough Device Designation for Ovarian Cancer Screening in Asymptomatic, Postmenopausal Women FDA BDD | Mercy BioAnalytics, FDA

2 | Chugai Obtains Approval for FoundationOne Liquid CDx Cancer Genomic Profile to Provide Information on Detection of Copy Number Alterations of Cancer-Related Genes and bTMB Score (Japan) Biomarker Approval | Chugai Pharmaceutical, Foundation Medicine, Japanese MHLW

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Company Announcements & Product Launches

1 | Telo Genomics and Emery Pharma Announce Collaboration Collaboration | Telo Genomics, Emery Pharma

2 | Inocras and IMBdx Announce Strategic Partnership to Transform Cancer Patient Care in the U.S. Partnership | Inocras, IMBdx

3 | Sheba Medical Center & Salignostics to Develop Saliva Test for Early Oral Cancer Detection Collaboration | Sheba Medical Center, Salignostics

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