An IVD-labeled 7500 Fast Dx Real-Time PCR Instrument supports European clinical laboratory requirements for having standardized instruments among different laboratories, said Dr. Danilo Tiziano, Assistant Professor at the Institute of Medical Genetics of Catholic University. This instrument would help us to improve the quality and reliability of in vitro molecular diagnostic assays used in the development of clinical markers.

Introduced in the United States in 2008, the 7500 Fast Dx Real-Time PCR Instrument was designed for researchers and clinicians interested in developing and submitting medium-throughput in vitro molecular diagnostic assays to the FDA. When launched in the U.S., the instrument became the only real-time PCR instrument with FDA 510(k) clearance to perform the CDC ™s Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel).

IVD validation for the 7500 Fast Dx Real-Time PCR Instrument extends the reach of our industry-leading molecular detection technology in Europe beyond research labs and into clinical and diagnostic markets, said John Gerace, Vice President and General Manager of PCR Systems for Life Technologies. The availability of a platform validated for use in these markets will have a profound impact on the development of new assays for diagnosing a wide variety of different diseases.

SOURCE: Life Technologies Corporation