CARLSBAD, Calif., April 26, 2013—Life Technologies Corporation (NASDAQ: LIFE) announces that its Applied Biosystems® 7500 Fast Dx Real-Time PCR instrument is indicated for use with the CDC A/H7 Assay, which has received Emergency Use Authorization for detection in patient specimens of the novel influenza A (H7/N9) virus. To date the virus has led to 35 deaths in China and Taiwan.
The CDC’s Influenza A/H7 (Eurasian Lineage) Real-Time RT-PCR Diagnostic Assay has received Emergency Use Authorization for detection in patient specimens of the novel influenza A (H7/N9) virus. This test has been authorized only for the diagnosis of A (H7N9) influenza virus and not for the diagnosis of any other viruses or pathogens. Life Technologies’ Applied Biosytems 7500 Fast Dx Real-Time PCR instrument is the sole platform indicated for use with the CDC A/H7 Assay. Additionally, the CDC A/H7 Assay can be performed using Life’s SuperScript III One-Step qRT-PCR reagent kit. The CDC A/H7 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.
The CDC A/H7 Assay has not been FDA cleared or approved, nor has FDA determined, as permitted under section 564(m) of the Act, that this test may be performed in settings with certificates of waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a.
The CDC A/H7 Assay is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C § 360bbb-#(b)(1), unless the authorization is revoked sooner and the declaration of emergency will terminate when the HHS Secretary determines that the circumstances of a significant potential for a public health emergency have ceased to exist or when there is a change in the approval status of the CDC A/H7 Assay such that the authorization of emergency use is no longer needed, whichever occurs earlier.
Life Technologies has a strong history of working with the CDC, the World Health Organization (WHO) and public health labs to combat virus outbreaks:
“We have learned through our past experiences that a strong surveillance program is crucial in times like these,” said Dan Didier, Public Health Director for Life Technologies. “We are working continually with our partners around the globe on improving our capabilities, particularly when it comes to developing rapid detection kits.”
Cases of the H7N9 virus have been reported out of China and Taiwan only. First cases of the human virus were confirmed in March with more than 100 cases.
The SuperScript III One-Step qRT-PCR kit is for research use only; not for use in diagnostic procedures.
About Life Technologies
Life Technologies Corporation (NASDAQ: LIFE) is a global biotechnology company that is committed to providing the most innovative products and services to leading customers in the fields of scientific research, genetic analysis and applied sciences. With a presence in more than 180 countries, the company's portfolio of 50,000 end-to-end solutions is secured by more than 5,000 patents and licenses that span the entire biological spectrum -- scientific exploration, molecular diagnostics, 21st century forensics, regenerative medicine and agricultural research. Life Technologies has approximately 10,000 employees and had sales of $3.8 billion in 2012.
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