Real-Time PCR with FDA Approval
Applied Biosystems, also a division of Life Technologies, presented the 7500 Fast Dx Real-Time PCR Instrument, a flexible, medium-throughput device, designed to facilitate assay development on an in vitro diagnostic platform.
The instrument is devised to meet current health challenges to the identification of influenza strains, especially the strain associated with the recent outbreak of the H1N1 virus (swine flu), according to a Life Technologies official. The FDA has authorized the emergency use of a new CDC rRT-PCR detection panel for the swine flu with instructions that the assay be performed on an Applied Biosystems 7500 instrument.
The company has formed a special 24/7 task force to coordinate the company-wide response to requests for assistance with the outbreak. The task force provides health agencies with support, including instrument training, supply chain management, and monitoring regulatory compliance. The company has also accelerated the manufacture of components that will be used by laboratories to test for and identify influenza.
Other products of relevance to management of a possible H1N1 outbreak include the MagMAX™ viral RNA isolation kits, the SuperScript® III Platinum® One-Step qRT-PCR kit, TaqMan® influenza A detection kit, and several different capillary electrophoresis systems for determining the base-by-base sequence of viral samples.
Last September, the 7500 Fast Dx instrument received 510(k) clearance from the FDA for use with the CDC Human Influenza Virus Detection and Characterization Panel (rRT-PCR Flu Panel). Both products are required to be used together as a system for the detection of influenza.