The U.S. Department of Health and Human Services (HHS) is supporting the development of a novel coronavirus diagnostic test by DiaSorin Molecular, LLC of Cypress, California. DiaSorin received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on March 19 for their COVID-19 Direct kit. DiaSorin will begin shipping kits for immediate use in laboratories across the US this week.
The Biomedical Advanced Research and Development Authority (BARDA) within the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) provided technical assistance and $697,000 for the development of the Simplexa™ COVID-19 Direct assay, a molecular test for qualitative identification of the novel coronavirus SARS-CoV-2 which causes COVID-19.
DiaSorin’s test will use a nasopharyngeal (back of the nose and throat) swab from patients and is designed for use with the company’s Simplexa™ Direct technology, a diagnostic platform currently used for their influenza and Respiratory Syncytial Virus (RSV) tests that have been cleared by the FDA.
The COVID-19 test would run on DiaSorin’s LIAISON® MDX instrument, which works in conjunction with LIAISON® MDX Studio software not only in reference laboratories, but also in labs that are closer to the patient, such as hospital labs. This technology uses a sample-to-answer approach with minimal operator input, yielding results in about 90 minutes. Hundreds of the company’s diagnostic devices are in use in large commercial, hospital, and public health laboratories around the country.
This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.
About the Company
DiaSorin Molecular LLC manufactures and distributes innovative molecular diagnostic products for hospital and reference laboratories. The company’s products help laboratories consolidate their testing, streamline processes and increase efficiency. DiaSorin Molecular’s Simplexa™ molecular diagnostic kits are designed for use on the company’s versatile LIAISON® MDX platform.