Life Technologies Corporation is providing its technologies to health officials across the globe to aid in the identification of influenza strains, particularly the strain associated with the recent outbreak of the influenza A H1N1 virus, also known as swine flu.
The company has formed a special 24-hour-a-day task force across key business units to coordinate the company-wide response to global requests for assistance with the outbreak. The task force is leading efforts to provide health agencies with front line support such as instrument training, managing the supply chain to ensure that products get to customers as quickly as possible, and ensuring appropriate regulatory compliance. Also, Life Technologies is accelerating the manufacture of components that will be used by laboratories to test for and identify influenza.
Life Technologies, through its Invitrogen and Applied Biosystems brands, offers components that support the workflow surrounding the identification of influenza virus strains including the MagMAX Viral RNA Isolation Kits for RNA purification; the SuperScript III Platinum One-Step qRT-PCR kit for amplification of viral RNA; TaqMan Influenza A Detection Kit 2.0 for initial influenza type A screening; and several different capillary electrophoresis systems for determining the base-by-base sequence of viral samples. Additionally, the company offers its 7500 Fast and Fast Dx Real-Time PCR instruments under the Applied Biosystems brand.
Last September, the 7500 Fast Dx instrument received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with the CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel) from the U.S. Centers for Disease Control and Prevention (CDC). While both products received independent FDA 510(k) clearances, they are required to be used together as a system for the detection of influenza.
Due to this public health emergency, the FDA issued the CDC a Letter of Authorization to allow for the emergency use of a new CDC rRT-PCR detection panel for the swine flu. The authorization letter instructs qualified laboratories to perform the assay on an Applied Biosystems 7500 Fast Dx Real-Time PCR instrument or the 7500 Fast Real-Time PCR instrument.
Date: April 30, 2009
Source: Life Technologies Corporation