BARDA is providing funding, technical assistance and expertise to support the development of a combination diagnostic test for influenza A/B and COVID-19. The new Simplexa™ COVID-19 & Flu A/B Direct assay will provide results in approximately 90 minutes and is performed using the company’s LIAISON® MDX, a diagnostic platform currently used for their influenza and Respiratory Syncytial Virus (RSV) tests that have been cleared by the U.S. Food and Drug Administration (FDA).
The funding also will be used for the validation of the Simplexa™ COVID-19 Direct assay, available under FDA’s emergency use authorization. This molecular test was supported by BARDA in March 2020, and the latest agreement provides additional studies necessary to request full 510(k) clearance to market the COVID-19 and the combination test kits.
DiaSorin’s tests use a nasopharyngeal (back of the nose and throat) or nasal swab or a bronchial lavage sample from patients and is designed for use with the company’s LIAISON® MDX, a diagnostic platform currently used for influenza and Respiratory Syncytial Virus (RSV) tests that have been cleared by the FDA.
The COVID-19 test can be used in moderate and high complexity laboratories, with many of their placements in labs that are closer to the patient, such as hospital labs. These tests offer a simplified a sample-to-answer workflow, with minimal operator input required. Test results are available in about 90 minutes.
About DiaSorin Molecular:
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.