Highlights & Summary

Liquid Biopsy (LBx) continued to develop through February, featuring new product launches as well as reimbursement coverage decisions.

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Featured DeciBio Insights

‍1 | Methylation Year in Review 2023 Blog Article | Katherine Erickson, DeciBio

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Clinical and Regulatory

The National Institutes of Health launched a clinical trials research network to evaluate the use of multi-cancer early detection tests. This Cancer Screening Research Network will initially provide funding through the National Cancer Institute (NCI) to eight institutions to support the Vanguard Study on Multi-Cancer Detection, which will enroll up to 24,000 participants and have three arms: a control arm that receives standard cancer screening and two arms that receive standard screening plus one of two different multi-cancer detection tests. The aims of the trial are to assess participant willingness for randomization, gauge adherence to testing and diagnostic follow-up, evaluate the feasibility of protocol-defined diagnostic workflows, determine reliability and timeliness of blood specimen testing and return by the diagnostics firms, and identify facilitators and barriers to trial participation for diverse groups. Additionally, February saw two Medicare coverage announcements, reimbursing LiquidHALLMARK in lung cancer and expanding Natera’s Signatera test for use in ovarian cancer and neoadjuvant breast cancer.

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1 | National Cancer Institute Establishes Research Network to Study Cancer Early Detection Tests MCED Research Network | NCI, Fred Hutchinson Cancer Center

2 | Lucence Announces Medicare Reimbursement Decision for LiquidHALLMARK® Assay in Lung Cancer Medicare Coverage | Lucence

3 | Medicare Extends Coverage of Natera’s Signatera™ MRD Test to Ovarian Cancer and Neoadjuvant Breast Cancer Medicare Coverage | Natera

Company Announcements & Product Launches

Exact Sciences announced the launch of Riskguard hereditary cancer test in the United States. The Riskguard test provides an individualized patient report that includes gene specific and familial risks using a simple blood or saliva sample for 10 common cancers, including colorectal, breast, prostate, skin, ovarian, endometrial, pancreatic, gastric, kidney and endocrine. AccuGenomics launched the AccuKit Myeloid DNA IS as internal standards for NGS to enhance MRD for AML. 

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1 | Exact Sciences Launches Riskguard Hereditary Cancer Test in the United States Product Launch | Exact Sciences

‍2 | AccuGenomics Launches AccuKit Myeloid DNA IS as Internal Standards for NGS to Empower AML Detection with Precision Product Launch | AccuGenomics

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Clinical Trials & Study Results

Myriad Genetics and National Cancer Center Hospital East announced a collaboration on a pan-cancer MRD monitoring clinical trial, SCRUM-MONSTAR-SCREEN-3, which will include ~1,200 patients across more than 20 cancer types, both solid tumor and hematological cancers. Reveal Genomics’ HER2DX, a 27-gene expression liquid biopsy test for patients with early-stage HER2-positive breast cancer, is undergoing evaluation in a clinical trial being conducted by the Hospital Clinic Foundation for Biomedical Research and the consortium August Pi i Sunyer Biomedical Research Institute, or FCRB-IDIBAPS. The All of Us Research Program is a longitudinal cohort study aiming to enroll a diverse group of at least one million individuals across the USA to accelerate biomedical research and improve human health, and identified more than 1 billion genetic variants, including more than 275 million previously unreported genetic variants. Genomics data for this release were generated from blood-derived DNA. 

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1 | Myriad Genetics and National Cancer Center Hospital East in Japan Collaborate on Pan-Cancer MRD Monitoring Clinical Trial, SCRUM-MONSTAR-SCREEN-3 Collaboration | Myriad Genetics, Inc., National Cancer Center Hospital East

2 | Reveal Genomics' HER2DX Clinical Validation Trial Underway in Europe Clinical Validation Trial | Reveal Genomics

‍3 | Genomic data in the All of Us Research Program Population Sequencing | All of Us

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M&A | VC | Private Equity | Legal

Freenome raised $254 million in funding from existing and new investors, led by Roche, to advance its pipeline of single- and multi-cancer early detection tests. EValuate Diagnostics, a spinout of Hackensack Meridian Health Research Institute's Center for Discovery and Innovation (HMCDI) developing extracellular vesicle-based diagnostics for early detection of tumors and other diseases, obtained $1 million in venture capital funding. Pharus Diagnostics, a Taiwanese early cancer detection firm, acquired an exclusive worldwide license from the City of Hope for a series of blood-based molecular biomarkers that could potentially be used in the early diagnosis of pancreatic ductal adenocarcinoma (PDAC). Renovaro Biosciences announced that its newly acquired subsidiary GediCube has executed a binding letter of intent (LOI) to acquire 75 percent of Dutch liquid biopsy firm Cyclomics, which has developed a circulating tumor DNA detection technology using Oxford Nanopore sequencing. 

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1 | Freenome Raises $254M to Study Cancer Screening Tests Fundraising | Freenome, Roche

2 | HMH spinoff, EValuate Diagnostics, gets $1M commitment from Foundation Venture Capital Group Venture Funding | EValuate Diagnostics

3 | City of Hope and PharusDx Sign License Agreement to Advance Early Test for Pancreatic Cancer Exclusive License | Pharus Diagnostics

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Additional Sources

M&A | VC | Private Equity | Legal

1 | GEDiCube to Acquire 75% of Liquid Biopsy Testing Provider Cyclomics Acquisition | GediCube, Cyclomics

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