Moderate Complexity Healthcare Facilities Test for Respiratory Viruses

This provides an important advance in near-patient molecular testing.

The new test aids in the qualitative detection and differentiation of RNA of influenza A and B viruses and RSV, common causes of respiratory illness. Focus Diagnostics (Cypress, CA, USA), maker of the Simplexa brand of molecular test kits, and 3M (St. Paul, MN, USA) 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 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, include certain types of physician’s offices, community hospitals, health clinics, and integrated delivery networks. These facilities frequently lack the personnel and technology to perform high-complexity molecular diagnostic tests. Because the test can now 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, MD, 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.”

The two collaborating companies announced that the US Food and Drug Administration (FDA; Silver Spring, MD, USA) has provided 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) moderate-complexity categorization to the Simplexa A influenza A and B and respiratory syncytial virus (RSV) on the 3M Integrated Cycler.

Related Links:
Focus Diagnostics
3M
US Food and Drug Administration