Highlights & Summary

Liquid Biopsy (LBx) continued to develop through March, featuring new trial launches and study results and new coverage designations.

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Featured DeciBio Insights 

1 | Regulatory Reckoning: Navigating the FDA's Laboratory Developed Tests Regulation White Paper White Paper | DeciBio

2 | In the Hot Seat: Challenging Conventions in Precision Medicine Webinar Webinar | DeciBio, TPP

Clinical and Regulatory

Florida Health Department selected using plasma DNA concentration (DiaCarta's RadTox™ test) for early detection of treatment response and resistance through the Casey DeSantis Florida Cancer Innovation Fund. The RadTox test will be used between radiotherapy or chemotherapy doses to detect treatment response or resistance as a real time predictor of imaging data. Natera announced commercial coverage for its Prospera Kidney and Heart tests via a Blue Cross Blue Shield plan. Prospera analyzes donor-derived cfDNA to evaluate risk of organ transplant rejection. Naveris’ NavDx test, which detects HPV-driven cancer by detecting viral HPV DNA in the blood, was designated as an Advanced Diagnostic Laboratory Test (ADLT).

1 | Florida Selects DiaCarta's cfDNA Test (RadTox™) for Statewide Use to Detect Early Response of Cancer Treatment Statewide Deployment | DiaCarta

2 | Natera Announces Commercial Coverage for Prospera™ Kidney and Prospera Heart™ from a Top BCBS Plan Commercial Coverage | Natera

3 | CMS Designates the NavDx® Test as an Advanced Diagnostic Laboratory Test (ADLT) ADLT Designation | Naveris

Company Announcements & Product Launches

Investigators at Johns Hopkins developed a novel approach that uses machine learning to identify repeats of DNA sequences that are found in chromosomes and could contribute to cancer. The method, called ARTEMIS, was able to identify changes in these elements in cfDNA, allowing detection of cancer as well as site of origin.

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1 | ‘Junk DNA’ No More: Johns Hopkins Investigators Develop Method of Identifying Cancers from Repeat Elements of Genetic Code Machine Learning | Johns Hopkins

Clinical Trials & Study Results

Data from the ECLIPSE study showed that SHIELD, Guardant’s blood-based test for colorectal (CRC) screening, detected 83% of people with CRC with a specificity of 90%. Natera announced another phase III CIRCULATE trial evaluating Signatera in stage II CRC, based in France. CIRCULATE-France’s main objective is to assess the benefit of adjuvant chemotherapy in Signatera MRD-positive patients. Personalis published analytical validation study results for its NeXT Personal MRD and monitoring assay, demonstrating a LOD95 of 3.45 parts per million (ppm).

1 | Guardant Health ECLIPSE Study Data Demonstrating Efficacy of Shield Blood-based Test for Colorectal Cancer Screening Study Data | Guardant Health

2 | Natera Announces Phase III Randomized CIRCULATE Trial in France, Evaluating Signatera™ in Stage II Colorectal Cancer Trial Announcement | Natera

3 | Personalis Announces Publication Validating NeXT Personal® Test for Ultra-sensitive MRD Detection and Cancer Treatment Response Monitoring Analytical Validation | Personalis

M&A | VC | Private Equity | Legal

Flomics Biotech closed a $1.2 million seed financing round. The Spain-based startup plans to use the funds to advance the preclinical validation of its cfRNA assay for early diagnosis of colorectal, lung, breast, prostate, and pancreatic cancer. Surge raised €7.5 million in its second round of funding, which will enable opening of Surge Lab for decrypting the immune system and PreCyte, a blood-based assay for predicting surgical complications.

1 | Flomics Biotech Raises €1.1M for RNA-Based Multicancer Test Seed Financing Round | Flomics Biotech

2 | Surge announces closing of a €7.5 million fundraising round to decrypt the immune system and transform precision medicine Second Funding Round | Surge

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