7500 Fast Dx Real-Time PCR Instrument Meets European Requirements for In Vitro Diagnostic Use

CARLSBAD, Calif.–Life Technologies Corporation (NASDAQ: LIFE) today 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 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.”

The 7500 Fast Dx Real-Time PCR Instrument enables scientists to complete real-time PCR amplification and accurately and precisely 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.”

About Life Technologies

Life Technologies Corporation (NASDAQ: LIFE) is a global biotechnology tools company dedicated to improving the human condition. Our systems, consumables and services enable researchers to accelerate scientific exploration, driving to discoveries and developments that make life even better. Life Technologies customers do their work across the biological spectrum, working to advance personalized medicine, regenerative science, molecular diagnostics, agricultural and environmental research, and 21st century forensics. Life Technologies had sales of $3.3 billion in 2009, employs approximately 9,000 people, has a presence in approximately 160 countries, and possesses a rapidly growing intellectual property estate of approximately 3,900 patents and exclusive licenses. Life Technologies was created by the combination of Invitrogen Corporation and Applied Biosystems Inc., and manufactures both in-vitro diagnostic products and research use only-labeled products. For more information on how we are making a difference, please visit our website: http://www.lifetechnologies.com. Follow Life Technologies on Twitter @LIFECorporation and on Facebook.

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