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Alere on Track to Launch HIV Viral Load Test Ex-US, File Isothermal Flu Assay with FDA in 2013

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Alere President and CEO Ron Zwanziger last week provided investors with an update on the development timeline for a pair of point-of-care nucleic acid testing plartforms, the company's first molecular diagnostics products.

During a conference call recapping Alere's second-quarter 2013 earnings, Zwanziger said that the company is on target to launch Alere Q, "our fully integrated, point-of-care, rapid, quantitative molecular platform" before the end of this year.

The first application of this platform is an HIV viral load assay, which Alere plans to introduce outside the US sometime in the fourth quarter. Eventually Alere plans to expand the Alere Q menu to address additional infectious disease targets areas such as hepatitis C virus, Zwanziger said.

In addition, Alere has successfully completed clinical trials on a second near-patient molecular testing platform, the Alere i, Zwanziger said. This cartridge-based product is focused on a range of infectious disease targets, but the first application will be a rapid flu assay designed to deliver results in approximately 15 minutes.

Zwanziger said that Alere plans to file the Alere i platform and flu test with the US Food and Drug Administration "later this year." Meantime, the company is also developing Alere i assays for Streptococcus A, respiratory syncytial virus, Clostridium difficile, and chlamydia.

Alere, formerly known as Inverness Medical Innovations until changing its name in May 2010, specializes in near-patient diagnostic testing products, but has not traditionally played in the molecular diagnostics space. The company does, however, have a strong patent portfolio surrounding lateral flow detection technology, which many other companies use in point-of-care immunoassay- and nucleic acid-based testing platforms.

In early 2011 the company began looking more closely at the MDx market when it agreed to exclusively distribute Spartan Bioscience's RX CYP2C19 — a PCR-based point-of-care platform that tests for the CYP2C19*2 mutation that impairs metabolization of the anti-coagulant Plavix — in Germany, Australia, and Switzerland (PCR Insider, 1/13/2011).

The next year Alere disclosed that it was developing the Alere Q, formerly known as the Alere NAT Analyzer; and the Alere i, formerly known as the iNAT (PCR Insider, 5/17/2012).

The Alere Q uses technology at least partially developed at Clondiag, a Jena, Germany-based biochip company that Alere predecessor Inverness acquired by in 2006. Alere has thus far disclosed that the Alere Q 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.

Meantime, the Alere i 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.

Ionian's nicking enzyme amplification reaction, or NEAR, technology, is based on very rapid detection of any small DNA or RNA fragments generated directly from a target nucleic acid. 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.

Zwanziger noted during last week's call that clinical researchers from Children's Mercy Hospitals and Clinics in Kansas City presented a pair of posters in April at the Clinical Virology Symposium in Daytona Beach, Fla., that demonstrated "outstanding performance that exceeds FDA's criteria" under the agency's proposed reclassification scheme for rapid influenza detection tests.

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