Life Technologies Gains IVD Mark for Real-Time PCR Instrument
Product News Mar 26, 2010
Life Technologies Corporation has announced that its Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument is available as a platform suitable for in vitro diagnostics (IVD) use in Europe.
Clinical laboratories from 22 countries and European institutions that develop in vitro molecular diagnostic assays in oncology, genetic disease and infectious disease will now be able to leverage the instrument’s regulatory clearance to develop tests for clinical applications.
The 7500 Fast Dx Real-Time PCR Instrument enables scientists to complete real-time PCR amplification and quantify nucleic acids in less than 40 minutes. The instrument’s software suite includes customizable security settings, and versatile security, auditing, and e-signature applications that allow users to record all instrument operations, supporting requirements of clinical laboratories to work in a secure environment.
Data analysis tools enable scientists to design laboratory tests that simplify detection and quantification of target nucleic acids. Users of the instrument are responsible for any validation of assays and compliance with any regulatory requirements that pertain to their procedure and instrument use.
At the Institute of Medical Genetics of Catholic University in Rome, researchers have been performing quantitative real-time PCR assays to study expression levels of a particular gene that may serve as a biomarker of spinal muscular atrophy (SMA), a disease that causes progressive muscle degeneration and weakness. An IVD-labeled real-time PCR instrument would enable researchers there to perform inter-laboratory comparisons of platforms, useful for the development of clinical markers for diagnosis of SMA.
“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.”