Jones Walker Attorneys Counsel Cormeum Lab Services LLC in Approval of Emergency Use Authorization From FDA for COVID-19 Molecular Test
NEW ORLEANS, July 22, 2020 /PRNewswire/ -- Cormeum Lab Services LLC, a high-volume Clinical Laboratory Improvement Amendments (CLIA) certified medical lab based in Marrero, Louisiana, recently received approval of its Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a PCR-based SARS-CoV-2 test. Jones Walker partner Nadia de la Houssaye advised Cormeum through the rigorous FDA EUA application process for the lab's COVID-19 PCR+Antigen/Antibody Test. Cormeum is an affiliate of New Orleans-based Sensiva Health LLC.
Cormeum's SARS-CoV-2 assay is designed to detect the N, S, and Ofr1ab regions within the COVID-19 virus' genome in nasopharyngeal swabs, runs on the Applied Biosystems QuantStudio 12K Flex RT-PCR instrument using software version 1.1.2, and may be performed only by the Marrero-based company. In addition, based on the approximately 175 clinical samples submitted to the FDA as part of its EUA approval process, Cormeum's testing solution received a 100% accuracy rating for both specificity and sensitivity.
"Thanks to Jones Walker's extensive experience and knowledgeable healthcare team's counsel to us throughout the entire FDA EUA process and beyond, we are now one of only 37 laboratory-developed tests that has received FDA EUA authorization during the COVID-19 pandemic, with literally hundreds of other laboratories continuing to await approval. It would be difficult to imagine navigating through this process and achieving this critical milestone for Cormeum's SARS-CoV-2 assay without their guidance and support," said Dr. Jim Silliman, president of Sensiva Health.
Nadia, co-leader of the firm's healthcare litigation team and head of the firm's healthcare industry telemedicine team, served as the lead attorney from Jones Walker, advising Cormeum through the FDA EUA process, which included ensuring that Cormeum's applications were compliant with evolving mandates from the FDA and updating the lab's EUA submissions with additional data as necessary. Asher Friend and Allison Bell, corporate partners in the New Orleans office and members of the firm's Healthcare Practice, also collaborated closely with Nadia and the client through the FDA process, and currently lead the Jones Walker team that is supporting Sensiva Health and its affiliates, including Cormeum, in a myriad of transactional matters and commercial opportunities related to the COVID-19 pandemic. In addition, to support patients who have tested positive for COVID-19 in seeking treatment from healthcare providers, Nadia and Allison worked on the integration of a telehealth service line with Sensiva Health's platform.
About Sensiva Health
Sensiva Health LLC is a premier, comprehensive COVID-19 solutions company composed of leading medical doctors, renowned epidemiologists, engineers, software developers, and logistics experts united to return the world to normalcy. Through our own labs, we have developed a proprietary platform of real-time PCR detection of SARS-CoV-2, first-to-market quantitative antibody testing, and decision-support software, and we control our own manufacturing and supply chain. For more information, visit sensivahealth.com.
About Jones Walker
Jones Walker LLP (joneswalker.com) is among the largest 120 law firms in the United States. With offices in Alabama, Arizona, the District of Columbia, Florida, Georgia, Louisiana, Mississippi, New York, and Texas, we serve local, regional, national, and international business interests. The firm is committed to providing a comprehensive range of legal services to major multinational, public and private corporations, Fortune® 500 companies, money center banks, worldwide insurers, and emerging companies doing business in the United States and abroad.
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SOURCE Jones Walker LLP
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