Focus Diagnostics and 3M have announced that the U.S. Food and Drug Administration (FDA) has provided 510(k) clearance and CLIA moderate complexity categorization to the Simplexa Flu A/B & RSV Direct test on the 3M Integrated Cycler. The new test aids in the qualitative detection and differentiation of RNA of influenza A and B viruses and respiratory syncytial virus (RSV), common causes of respiratory illness. Focus Diagnostics, maker of the Simplexa brand of molecular test kits, and 3M, maker of the 3M Integrated Cycler technology, developed the test through an exclusive global collaboration. The collaboration, formed in 2009, has produced several Simplexa molecular tests, including the first FDA-cleared commercial test for the influenza A H1N1 (2009) virus.
Moderate complexity laboratories, defined by the Clinical Laboratory Improvement Amendments (CLIA), include certain types of physician’s offices, community hospitals, health clinics, and integrated delivery networks. These facilities typically lack the personnel and technology to perform high-complexity molecular diagnostic tests. Since the test can be performed in these moderate complexity labs, patient results may be obtained readily to help speed therapeutic decisions.
The test was developed with funding from The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. It supports the development of new technologies with potential to be effective medical countermeasure products for public health emergency threats. BARDA awarded a $5.9 million contract for the test’s development. Read more on BARDA’s work with Focus Diagnostics and 3M to develop the new assay.
