FDA Clearance for Molecular Influenza and Respiratory Virus Simplexa Test

Focus Diagnostics, a business of Quest Diagnostics, and 3M, a global diversified technology company, have received U.S. Food and Drug Administration (FDA) 510(k) clearance and CLIA moderate-complexity categorization for 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.

The Simplexa Flu A/B & RSV Direct is now available in the United States. It was CE marked for distribution in Europe in 2011.

The Simplexa Flu A/B & RSV Direct molecular test is the first moderate-complexity molecular test from the Focus Diagnostics' Simplexa product line, significantly broadening potential clinical access to the Simplexa/3M technology. 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 does not require the time-consuming nucleic extraction process required by many molecular tests, and can be performed and produce results within an hour.

"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 Quest Diagnostics and Focus 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."

"We are pleased to be part of this development that brings near-patient quality molecular testing to localized healthcare settings, and see it as evidence that public-private collaborations can produce important medical technologies," said Tom Cole, global marketing manager for 3M Infection Prevention Division. "The availability of this test to a broad swath of healthcare professionals in the U.S. will no doubt advance the diagnosis and management of many patients this coming Flu/RSV season."