Life Technologies Screening Technology Receives Emergency Use Authorization
News Jun 26, 2013
Life Technologies Corporation announces that its Applied Biosystems® 7500 Fast Dx Real-Time PCR instrument is suitable for use with the CDC Novel Coronavirus 2012 Real-time RT-PCR Assay, which has received Emergency Use Authorization for detection in patient specimens of the novel Middle East Respiratory Syndrome Coronavirus (MERS-CoV). To date the virus has been found in Jordan, Qatar, Saudi Arabia, the United Arab Emirates (UAE), France, Germany, Italy, Tunisia and the United Kingdom. Globally, since September 2012, the World Health Organization (WHO) has been informed of a total of 64 laboratory-confirmed cases of the infection with MERS-CoV, including 38 deaths.
Additionally, the CDC Novel Coronavirus 2012 Assay can be performed using Life's SuperScript III One-Step qRT-PCR reagent kit. The Respiratory Syndrome Coronavirus (MERS-CoV) Assay is intended to quickly monitor the spread of the pathogen and thwart a potential pandemic. To support this global need, Life Technologies is increasing production of its reagents and shipping them to labs around the world. This test has been authorized only for the diagnosis of Respiratory Syndrome Coronavirus (MERS-CoV) and not for the diagnosis of any other viruses or pathogens.
"We are working continually with our partners to improve capabilities, particularly tests that work more quickly and simply on more people," said Mark Stevenson, president and chief operating officer at Life Technologies. "Our technology aids public health labs around the globe to identify threats and develop rapid detection kits."
The test has been authorized by FDA under an Emergency Use Authorization for use by qualified laboratories. The CDC Novel Coronavirus 2012 Assay has not been FDA cleared or approved.
The CDC Novel Coronavirus 2012 Assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of MERS-CoV under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C section 360bbb-3(b)(1).
Last year, Life Technologies established the Global Influenza Network, a partnership of scientists at a number of the world's leading government public health organizations, veterinary agencies and research institutes who collaborate in an effort to increase the speed and efficiency of influenza monitoring and vaccine development. This network builds upon Life Technologies' strong history of working with the CDC, the WHO and public health labs to combat virus outbreaks:
• Last month, the company's 7500 Fast Dx Real-Time PCR instrument was indicated as the sole instrument for use with the CDC's influenza A (H7/N9) virus, which received emergency use authorization for detection in patient specimens of the novel influenza A (H7/N9) virus.
• In 2011, the company developed a custom assay to accurately detect the E. coli bacterium that spread through Europe. The assay was developed after company researchers, using samples supplied by scientists at University Hospital Munster, completed the DNA sequencing and analysis work on the deadly E. coli strain using the Ion PGM™ Sequencer.
• In 2009, Life Technologies formed a special 24-hour-a-day task force to respond to global requests for assistance with the H1N1 outbreak.
The SuperScript III One-Step qRT-PCR kit is for research use only; not for use in diagnostic procedures.