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Life Tech's ABI 7500 Fast Dx Platform Gets Nod for IVD Use in Europe


By Ben Butkus

Life Technologies said yesterday that its Applied Biosystems 7500 Fast Dx real-time PCR instrument has met CE Mark requirements for in vitro diagnostic use in Europe.

The approval expands the market for Life Tech's molecular detection technologies in Europe beyond research labs and into clinical and diagnostic markets, a Life Tech official said.

In addition, European customers using or planning to use the 7500 Fast Dx instrument to develop IVD content now have a "much easier" path when submitting a complete IVD platform for regulatory approval by European authorities, the official said.

The CE Mark for IVD is regulated in the 30 member states of the European Union and European Free Trade Association that comprise the European Economic Area.

According to Life Tech, clinical laboratories in 22 European countries are using the 7500 Fast Dx to develop in vitro molecular diagnostic assays in oncology, genetic disease, and infectious disease, and will now be able to leverage the instrument's regulatory clearance to develop clinical tests.

"The type of diagnostic laboratories the 7500 Fast Dx is being used in are typically developing homebrew diagnostic tests that still have to go through the clearance process," John Gerace, vice president and general manager of PCR systems for Life Tech, told PCR Insider.

"This minimizes the time and expense associated with submitting a complete solution for approval," Gerace added. "It's an enabling tool for customers who want to put diagnostic content on this platform."

Gerace also said that many of Life Tech's European customers have already created diagnostic content on the 7500 Fast Dx system, and as such "this makes their job of clearing a complete solution that much easier."

As an example, Life Tech said that researchers at the Institute of Medical Genetics of Catholic University in Rome have been using quantitative real-time PCR to study expression levels of a particular gene that may serve as a biomarker of spinal muscular atrophy.

Life Tech said that an IVD-labeled real-time PCR instrument would enable those researchers to perform inter-laboratory comparisons of platforms, which may be useful for developing clinical markers for diagnosing SMA.

"An IVD-labeled 7500 Fast Dx real-time PCR instrument supports European clinical laboratory requirements for having standardized instruments among different laboratories," Danilo Tiziano, assistant professor at the IMG, said in a statement. "This instrument would help us to improve the quality and reliability of in vitro molecular diagnostic assays used in the development of clinical markers."

In addition, Gerace said that the IVD approval is also expected to generate additional sales of the platform in Europe, since laboratories that are developing IVD assays may now choose the 7500 Fast Dx.

"We already have an attractive position throughout the world, and especially in Europe" in terms of 7500 Fast Dx sales, "and this fortifies that position," Gerace said.

Introduced in the US in 2008, the 7500 Fast Dx platform was designed for researchers and clinicians interested in developing and submitting medium-throughput in vitro molecular diagnostics to the US Food and Drug Administration.

In September of that year, the instrument became the only real-time PCR system to receive FDA 510(k) clearance to perform the Center for Disease Control and Prevention's human influenza virus real-time RT-PCR detection and characterization panel.

According to Life Tech, the instrument enables scientists to complete real-time PCR amplification in less than 40 minutes. The instrument's software includes customizable security settings, as well as security, auditing, and e-signature applications that allow users to record all instrument operations.

Users of the instrument are responsible for any validation of assays and compliance with any regulatory requirements pertaining to their procedure and instrument use, Life Tech said.