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Alere Provides Update on Commercialization Timeline for Nucleic Acid-Based Testing Platforms

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Health management services and diagnostics firm Alere recently updated investors on the progress of a pair of nucleic acid testing platforms that are currently under development at the company and represent the firm's entrée into molecular diagnostics.

During a conference call earlier this month recapping Alere's fourth-quarter and full-year 2012 earnings, CEO Ron Zwanziger told investors that qNAT, the company's rapid molecular HIV viral load monitoring platform, is expected to launch outside the US later this year, with future follow-on tests for hepatitis C and tuberculosis.

In addition, Zwanziger said that iNAT, Alere's platform for acute near-patient molecular testing, is currently progressing through clinical trials in the US. Alere hopes that the first test for this system, a rapid influenza assay, will be ready for marketing for the 2013 to 2014 flu season, and the company plans to commercialize follow-on tests for Group A Streptococcus, respiratory syncytial virus, and Clostridium difficile.

Alere, which until 2010 was known as Inverness Medical Solutions, first disclosed details surrounding its nucleic acid testing platforms a little over a year ago, at the January 2012 JP Morgan Healthcare conference in San Francisco (PCR Insider, 5/17/2012).

At the time, Zwanziger referred to the rapid HIV viral load testing platform as the NAT Analyzer, and said that the system would enable multiplexed nucleic acid measurements from small-volume whole blood samples. Sometime prior to last month, when the company presented at this year's JP Morgan Healthcare conference, it had changed the name of the platform to qNAT. Meantime, the iNAT moniker has remained the same.

Both platforms use technologies that Alere brought in house through various acquisitions over the past few years.

The qNAT platform is based on technology at least partially developed at Clondiag, a Jena, Germany-based biochip company that was acquired by Alere predecessor Inverness in 2006.

At the American Association for Clinical Chemistry's 44th Annual Oak Ridge Conference last April, researchers from Alere's Jena-based division disclosed additional details about qNAT. Specifically, the system will be battery powered; will fully automate sample prep and nucleic acid extraction; and will feature a combined temperature control and real-time fluorescence imaging module to enable high-speed target amplification and real-time multiplex detection based on what the researchers called "proprietary competitive reporter amplification" technology.

The same researchers described this technology in more detail in a paper published in PLOS One just a few days after the Oak Ridge conference.

Briefly, in the CMA technique, high-speed target amplification and real-time multiplex detection and quantification are accomplished using a capture probe array and specific reporter probes. The reporter probes are fluorescently labeled oligonucleotides that complement capture probes on an array and target nucleic acids in solution. The capture probes and amplified target compete for reporter probes, which then increases amplicon concentration and leads to decreased fluorescence signal at the respective capture probe position on the array. This fluorescence decrease can be measured after each cycle of amplification.

The upshot of the method is that, by using just one fluorescence dye for all targets and controls, it overcomes some of the multiplexing limitations of current real-time quantification methods, the researchers wrote.

Meantime, the iNAT system integrates isothermal amplification technologies that Alere acquired in 2010 along with TwistDx and Ionian Technologies.

TwistDx's recombinase polymerase amplification, or RPA, method uses recombinase enzymes to pair oligonucleotide primers with homologous sequences in duplex DNA. This method directs DNA synthesis to defined points in sample DNA and, if the target sequence is present, DNA amplification is initiated without thermal cycling or chemical melting.

The method works optimally at around 37 °C and can specifically amplify DNA to detectable levels from just a few target copies within five to 10 minutes. TwistDx is also currently working with Seattle's PATH institute to integrate the RPA technology in a potentially non-instrumented point-of-care nucleic acid amplification test to diagnose HIV-1 in infants in resource-poor areas of the world.

Ionian Technologies, meanwhile, developed the nicking enzyme amplification reaction, or NEAR, technology. This isothermal method is based on very rapid detection of any small DNA or RNA fragments generated directly from a target nucleic acid, according to the company's website. No separate cDNA synthesis step is necessary to detect RNA targets, and the amplification products can be detected by a variety of methods, including LC-MS, real-time fluorescence, and capillary electrophoresis.

It is unclear whether or how Alere is integrating these technologies into the iNAT platform.

During the conference call this month, Alere's Zwanziger acknowledged that the company, which has been a powerhouse for several years in the point-of-care immunoassay market, is "relatively late" to the molecular diagnostics market.

"This delay was the result of our conviction that, for success in a near-patient setting, a molecular platform needs to be not just accurate, but incredibly fast and easy to use," Zwanziger said. For example, Zwanziger said that the iNAT platform is designed to be CLIA waived.

"Having identified and acquired the necessary underlying technologies several years ago, there is growing excitement as the completed platforms approach commercialization."

Zwanziger added that Alere's "large, direct global sales footprint for rapid diagnostics, combined with proprietary new devices that offer speed, ease of use, and quantification, have us extremely optimistic about our ability to capitalize on the global trend towards molecular testing. As established markets begin to transition to the improved performance associated with molecular testing without sacrificing simplicity, we expect to benefit from both expanded reimbursement and usage."

Further detailing Alere's molecular diagnostics strategy, Zwanziger told analysts that the company had been determined to identify technologies that would lead to a truly rapid test — "a test that anyone can use by themselves in any setting, any ambulatory setting," he said.

Zwanziger also said that all of Alere's molecular diagnostics technology involves "very high-volume … manufacturing, which necessitates much more effort up front in terms of plants, and design, and optimization, and so forth. Once you get through that, you end up with good gross margin ability to make some real money."

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