The FDA has 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 (NYSE:MMM) 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, MD, 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.”
“Our exceptional collaboration with Focus Diagnostics  underscores 3M’s commitment to leading the industry in introducing new  technologies in clinical diagnostics,” said Debra Rectenwald, vice president,  general manager, 3M Infection Prevention Division. “We are excited that Focus  Diagnostics will be able to implement a real-time molecular technology that  can improve the speed and meet the demand for H1N1 testing.”
Quest Diagnostics’ Focus Diagnostics has a track  record of being first to market with new laboratory testing services for  emerging infectious diseases. On July 24, 2009, FDA announced that it had  issued its first emergency use authorization for a commercial 2009 H1N1  influenza virus test to Focus Diagnostics for a laboratory developed test it  had launched in May 2009. This EUA was issued for the test running on  equipment from Roche and Applied Biosystems.
The Focus Diagnostics Simplexa™ Influenza A H1N1  (2009) test, which employs real-time polymerase chain reaction (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.”

Source: Quest Diagnostics