FDA Issues EUA for Simplexa™ Influenza A H1N1

The FDA have issued a second emergency use authorization (EUA) to Focus Diagnostics, the infectious disease diagnostics business of Quest Diagnostics Incorporated, for its 2009 H1N1 influenza virus test.

With the EUA, Focus Diagnostics is the only company in the U.S. to offer test kits for detecting the pandemic 2009 H1N1 virus that the FDA has authorized for emergency use by CLIA high-complexity labs, which include certain hospital and regional labs. The test allows clinicians to quickly and definitively identify infected patients, differentiating from those who have similar symptoms.

The new EUA authorizes Focus Diagnostics to market and offer its Simplexa™ Influenza A H1N1 (2009) test for use on the 3M™ Integrated Cycler from 3M to CLIA high complexity laboratories for the duration of the emergency. The 3M Integrated Cycler is a microfluidic molecular diagnostic testing system and is not FDA cleared or approved. Used on the 3M platform, the test 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.

The new test offering is one outgrowth of an exclusive global distribution agreement formed between Focus Diagnostics and 3M under which Focus will develop and offer its first line of molecular diagnostic test kits, to be sold under the Simplexa brand name, on the 3M Integrated Cycler. The 2009 H1N1 influenza test kit is the first offering from the Simplexa product line, and the company plans to launch additional Simplexa test kits on the 3M Integrated Cycler for infectious diseases in 2010.

'FDA´s EUA for our new Simplexa H1N1 test on the 3M Integrated Cycler is a major advance for 2009 H1N1 influenza testing,' said Jon R. Cohen, M.D., senior vice president and chief medical officer, Quest Diagnostics. 'Until now, many CLIA high complexity labs didn´t have the technology, space or expertise to perform molecular testing for the 2009 H1N1 flu virus. Our relationship with 3M means that not only will more labs be able to perform this type of testing, but they will also be able to fulfill higher levels of testing demand. Expanded lab capability may be critical to the nation´s management of increased 2009 H1N1 testing this winter.'

The Focus Diagnostics Simplexa™ Influenza A H1N1 (2009) test, which employs real-time PCR, qualitatively detects RNA of the 2009 H1N1 flu virus in a patient´s nasal or nasopharyngeal specimens. The test 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.

The 3M Integrated Cycler is an instrument offering real-time polymerase chain reaction (PCR) technology that provides results in 30-75 minutes. The compact instrument utilizes advanced data management software to help laboratories process, store and transfer data quickly and effectively. In addition, the instrument has a small laboratory footprint at approximately 12 inches high and 12 inches deep, and can process up to 96 samples per run.

'Our reference laboratories typically report results within 24 hours of receipt of specimen,' said John G. Hurrell, PhD, vice president and general manager, Focus Diagnostics. 'With the Simplexa test on the 3M Integrated Cycler, a typical CLIA high-complexity laboratory can generate results within hours, considerably reducing time spent to send a specimen to an outside lab. Faster turnaround time can aid in clinical management of the patient and allow hospitals to segregate infected patients from other high-risk individuals.'

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, CA, as well as at its Nichols Institute laboratories in San Juan Capistrano, CA, and Chantilly, VA, and its Specialty Laboratory in Valencia, CA.