By Kirell Lakhman
FDA late last week awarded a second emergency-use authorization for Quest’s Focus infectious disease-diagnostics business to sell its 2009 H1N1 influenza virus test nationwide.
As I reported in July, FDA awarded Focus an EAU to offer to high-complexity labs in the US a real-time PCR-based test for the 2009 H1N1 virus running on equipment made by Roche and Applied Biosystems.
The resulting LDT, which can yield results within 24 hours of sample receipt, is designed to differentiate the pandemic virus from seasonal human influenza A by targeting two separate regions of the hemagglutinin gene of the virus.
The new EUA, granted Oct. 16, authorizes Focus to market and offer its Simplexa Influenza A H1N1 (2009) test for use on the 3M Integrated Cycler made by 3M. As with the first EAU, the assay will be marketed to CLIA high-complexity labs for the duration of the ongoing H1N1 emergency.
In a nutshell, the Focus Diagnostics Simplexa Influenza A H1N1 (2009) test employs real-time PCR to qualitatively detect RNA of the 2009 H1N1 flu virus in a patient's nasal or nasopharyngeal specimens. The test, which yields results in 30-75 minutes, targets a separate region of the hemagglutinin gene of the 2009 H1N1 influenza virus to differentiate the presence of the 2009 H1N1 flu virus from seasonal human influenza A virus.
According to Quest, the 3M Integrated Cycler has a “small laboratory footprint” at approximately 12 inches high and 12 inches deep, and can process up to 96 samples per run. Neither FDA cleared nor approved, it is a microfluidic molecular diagnostic testing system that “can provide increased capacity for 2009 H1N1 influenza virus testing to a wide range of CLIA-high complexity laboratories, including many hospitals, coping with a surge in testing demand.”
Quest said the new test is an “outgrowth” of an exclusive global-distribution agreement between Focus and 3M under that requires Focus develop and offer its first line of molecular diagnostic test kits, to be sold on the 3M Integrated Cycler under the Simplexa brand name.
Quest Diagnostics performs H1N1 flu testing using the Focus Diagnostics test authorized for emergency use by FDA in July at its Focus Diagnostics
laboratory in Cypress, Calif., as well as at its Nichols Institute laboratories in San Juan Capistrano, Calif., and Chantilly, Va., and its Specialty Laboratory in Valencia, Calif.