Collaborators Focus Diagnostics, maker of the Simplexa brand of molecular test kits, and 3M, maker of the 3M Integrated Cycler technology, have received U.S. Food and Drug Administration (FDA) 510(k) clearance and CLIA moderate-complexity categorization for an influenza diagnostic developed through funding by the U.S. Department of Health and Human Services BARDA BAA program for public health preparedness.
The Simplexa Flu A/B & RSV Direct test on the 3M™ Integrated Cycler 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. 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.
The assay is the first ‘moderate-complexity’ molecular test from the Focus Diagnostics’ Simplexa product line. Moderate complexity laboratories 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 future of influenza and all respiratory virus testing is molecular diagnostics, given its potential for high sensitivity and fast reporting of test results, which are essential for patient management,” said Jay M. Lieberman, M.D., medical director, infectious diseases, for Focus Diagnostics and parent company Quest Diagnostics. “The clearance and moderate complexity categorization of the Simplexa test on the 3M Integrated Cycler signifies an important step forward in expanding access to near-patient molecular testing, potentially helping clinicians to make better decisions for their patients.”
The new Simplexa test was developed in part with $5.9 million in funding from The Biomedical Advanced Research and Development Authority (BARDA) under Contract No. HHSO100201000049C.