Highlights & Summary

Liquid Biopsy (LBx) continued to develop through July, featuring new payor coverage announcements and new studies and results.

Clinical & Regulatory

In liquid biopsy clinical and regulatory news, NeoGenomics was awarded Medicare coverage for their RaDaR assay, previously given Breakthrough Device Designation by the FDA, to be used for MRD detection in breast cancer patients. The coverage applies to patients who have had stage II or III hormone receptor-positive (HR+), and human epidermal growth factor receptor 2-negative (HER2-) breast cancer, and who were diagnosed at least 5 years earlier. Guardant Health has also announced the decision by Blue Cross and Blue Shield of Louisiana to cover their Reveal MRD test. The coverage came into effect on July 10, and applies to individuals who have received treatment with curative intent for stage II or III colorectal cancer. The first covered test is to occur 4-6 weeks post-surgery or 2-4 weeks after completing a regimen of systemic therapy. July also saw Laboratory for Advanced Medicine & Health Group (LAMH) secure approval from the National Medical Products Administration (NMPA) in China for its liver cancer EDx test. LAMH is the sister company of California-based Helio Genomics.

1 | NeoGenomics Announces Medicare Coverage for RaDaR Assay for Minimal Residual Disease and Recurrence in Breast Cancer  Medicare Coverage| NeoGenomics

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2 | Guardant Health receives first commercial payor coverage for Guardant Reveal™ test from Blue Cross and Blue Shield of Louisiana Private Insurance Coverage | Guardant Health

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3 | Helio Genomics Sister Company, LAMH, Receives NMPA Approval in China for Innovative Product NMPA Approval | Helio Genomics, LAMH

Company Announcements & Product Launches

This month, Tempus announced its longitudinal GEMINI NSCLC study, which will be conducted in collaboration with AstraZeneca. The project aims to understand the impact of disease biology and biomarker status on therapy efficacy and disease progression by following patients with both Stage IV and early-stage NSCLC for up to 3 years, using a mix of solid and liquid tumor assays. The Israeli company MetaSight Diagnostics has partnered with Kahn-Sagol-Maccabi (KSM). Their joint effort will employ MetaSight’s liquid biopsy technology to screen a collection of hundreds of thousands of serum samples in order to develop diagnostics for a range of diseases. Zymo Research and Opentrons have formed a partnership of their own, which will apply Opentrons Flex platform, and Zymo’s chemistry, to develop technology for improved cfDNA purification. Their goal is to create an automated LBx workflow, while optimizing sensitivity.

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1 | Tempus Announces the GEMINI Non-Small Cell Lung Cancer Study Partnership | Tempus, AstraZeneca

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2 | MetaSight Diagnostics Emerges from Stealth and Announces Partnership with Maccabi's KSM Research and Innovation Center to Conduct Extensive Metabolomics Research | Business Wire  Research Partnership | MetaSight Diagnostics, KSM

3 | Revolutionizing Liquid Biopsy Partnership | Zymo Research, Opentrons Labworks 

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Clinical Trials & Study Results

Clinical trial results found that the use of ctDNA genotyping before tissue diagnosis in a group of patients suspected with NSCLC is associated with accelerated treatment timelines compared to reference cohorts who only undergo tissue testing exclusively. Of the patients diagnosed with advanced NSCLC and qualified for the trial (90 patients), 12% had actionable alterations identified through ctDNA analysis. Researchers at Icahn School of Medicine at Mount Sinai found that liquid biopsy can be an adjunct biomarker for diagnosis and monitoring of HPV-associated oropharyngeal cancer. A retrospective observational cohort study that included a total of ~450 patients demonstrated that a commercially-available blood test to analyze tumor tissue-modified viral-HPV DNA showed 100% specificity for the diagnosis of oropharyngeal cancer and its likelihood for recurrence. Hummingbird Diagnostics GmbH published study results indicating that a small RNA-based blood test can be an alternative to low-dose computed tomography screening. The small RNA-based blood test ~1,400 individuals received, called miLung, was validated as a biomarker to detect lung cancer across a cohort of ~440 individuals. Researchers in the study identified a tumor-shed, plasma-bound ribosomal RNA fragment as a strong predictor of lung cancer. 

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1 | Association of Circulating Tumor DNA Testing Before Tissue Diagnosis With Time to Treatment Among Patients With Suspected Advanced Lung Cancer: The ACCELERATE Nonrandomized Clinical Trial  Clinical Trial Results | Lung Health Foundation Breathe Better Breathing as One, Princess Margaret Cancer Foundation, Merck Canada/MaRS Discovery District Lung Cancer Innovation Challenge

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2 | Liquid Biopsy Shows Big Promise in Oropharyngeal Cancer  Study Result | Icahn School of Medicine at Mount Sinai

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3 | Hummingbird Diagnostics announces publication of miLung small RNA-based blood test for early detection of lung cancer in the Journal of Thoracic Oncology  Study Result | Hummingbird Diagnostics

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M&A | VC | Private Equity | Legal

Illumina was fined 432 million euros by the EU for its acquisition of Grail prior to receiving EU antitrust approvals. Grail was given a 1000 euro fine for its role in the infringement. Natera filed a lawsuit against NeoGenomics Labs in the North Carolina Federal District Court due to infringement of multiple patents by NeoGenomics’ RaDaR molecular residual disease assay. This follows another infringement lawsuit in the United States District Court for the District of Delaware related to RaDaR tests sold by NeoGenomics’ affiliate, Inivata. The jury ruled in favor of Natera in that case. Personalis sued Foresight Diagnostics for the alleged infringement of 3 patents. Personalis notes that Foresight Diagnostics built its solid tumor minimal residual disease approach on technology that Personalis has already patented. 

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1 | Illumina hit with record $476 million EU antitrust fine over Grail deal | Reuters  Antitrust Fine | Illumina, Grail, European Commission

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2 | Natera Files Patent Infringement Suit Against NeoGenomics  Lawsuit | Natera, NeoGenomics

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3 | Personalis Again Sues Foresight Diagnostics for Alleged Patent Infringements - MarketWatch  Patent Lawsuit | Personalis, Foresight Diagnostics

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Additional Sources

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Clinical & Regulatory

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1 | Devyser's NGS products for monitoring of kidney and stem cell transplanted patients receive IVDR approvals IVDR Certification | Devyser

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Company Announcements & Product Launches

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1 | Epigenomics AG Announces Successful Agreement on the Acquisition of Significant Assets  Divestiture | Epigenomics, New Day Diagnostics

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2 | Circular Genomics Announces Two Significant Steps Forward in Linking CircRNA to the Detection, Therapy Selection and Monitoring of Depressive Conditions  Upcoming Product Launch | Circular Genomics

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3 | DiaCarta and HMC/HML Team up for Customizing Lab Development Test Validations and Compliances in the US Market  Partnership | DiaCarta, Hopkins MedTech

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