Sensiva Health Receives Caribbean Public Health Agency Emergency Use Authorization For Its Sensiva C19™ COVID-19 Test
Authorized by the U.S. Food & Drug Administration (FDA) in July for Emergency Use Authorization (EUA) under Sensiva’s affiliate lab Cormeum Lab Services, Sensiva C19™ is a gold standard real-time multi-method collection test with 100 percent specificity and sensitivity, offering next-day risk of exposure information. With CARPHA’s EUA now officially in place, Sensiva C19™ will be widely available for fast, accurate COVID-19 testing throughout the Caribbean, enabling healthcare providers to respond more rapidly to patients’ health needs during the current health crisis.
Jones Walker Attorneys Counsel Cormeum Lab Services LLC in Approval of Emergency Use Authorization From FDA for COVID-19 Molecular Test
"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.