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Life Tech's PCR VP Says New HRM Reagents Are in Line with Push Toward Clinical Research

NEW YORK (GenomeWeb News) – Life Technologies' Applied Biosystems business recently launched a set of reagents for high-resolution melt analysis on real-time PCR systems. The MeltDoctor kits — ABI's first reagent offering for HRM — are among a series of moves that the company is making to expand its PCR business in the clinical market, an ABI official told GenomeWeb Daily News.

The MeltDoctor HRM reagents are marketed for research use only, but they enable a number of RT-PCR applications — namely mutation scanning, genotyping, and methylation — that are of great interest to the clinical and diagnostic community, John Gerace, vice president and general manager of Life Tech's PCR business, told GWDN.

"These particular reagents are for research use only. They can be used in clinical research applications, but are not indicated for clinical diagnostic use," Gerace said. "But will they find themselves eventually as a diagnostic? I'd say certainly yes."

Gerace noted that the reagent launch is the latest among several steps the firm has taken recently to expand its PCR offerings into the clinical research realm. One of those was the acquisition of microfluidics firm Cytonix during the second quarter for its intellectual property related to digital PCR technology.

"We are using this IP to create a digital PCR application that could have — like HRM — clinical value, and as a company it's bringing us closer and closer to providing, ultimately, a molecular diagnostic kit," Gerace said.

Furthermore, the company last year received 510(k) clearance from the US Food and Drug Administration for its 7500 Fast Dx Real-Time PCR instrument for use with the US Centers for Disease Control and Prevention's H5N1 flu panel.

Adoption of the instrument has been "through the roof," Gerace said, not least because of the recent H1N1 outbreak. In April, the FDA issued an Emergency Use Authorization that enabled the use of the CDC flu panel in combination with the 7500 Fast Dx instrument to detect H1N1.

Since then, the instrument has been used "very heavily by the CDC and the laboratory response network and public health labs around the world," Gerace said, adding that there are already "several hundred instruments" installed.

He added that the Cytonix acquisition, the launch of the 7500 Fast Dx instrument, and the HRM MeltDoctor reagents "shows you where we're going. In terms of what the future looks like for us, anticipate either more enabling technology, partnerships, or direct participation in the clinical markets."

He said that Life Technologies has additional technologies in its PCR pipeline that would be of immediate interest for clinical research, and ultimately for use as a diagnostic kit.

Gerace stressed that Life Tech does not currently have any of its own FDA-cleared molecular diagnostic q-PCR kits, "but we have a very large footprint in the lab-developed test market, so it's only a natural progression for us to follow that continuum down into providing a diagnostic kit."

This goal would likely be accomplished through a two-pronged approach that would involve partnerships with diagnostic firms as well as internal development, he said.

Since the 7500 Fast Dx was 510(k)-cleared by the FDA in conjunction with the CDC H5N1 assay, "we're really promoting [the 7500 Fast Dx] for people who want to get their assays cleared on a real-time PCR instrument and through the regulatory process," he said. "This is the instrument that clears the path for them."

The newly launched MeltDoctor reagents have been "optimized" for applied Biosystems instruments, but they can be used on any third-party cycler, Gerace said.

He noted that the company has had the software and instrument capabilities in place for HRM for several years, but the new kits are its first reagent product for this application.

"We did it in phases," he said. First the company offered the software-and-instrument combination, "and then we decided that the business opportunity was there that justified developing a kit."

Gerace said that Life Tech is seeing "increased demand" for HRM, but added that it's still an emerging area within the context of other PCR applications.

"If you look at the application, it's DNA variation — such as SNP and methylation studies — and that's a relatively low usage compared to the most typical use of real-time PCR: quantitative gene expression."

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