Clinical diagnostics and healthcare company Alere today announced the European launch of the Alere i platform and Influenza A & B test, a molecular assay designed to detect and differentiate those viruses in less than 15 minutes.
The test and Alere i platform, which uses isothermal nucleic acid amplification technology to facilitate point-of-care testing, is now commercially available in Austria, France, Spain, Switzerland, Germany, Italy, and the UK. The test is not yet available in the US but is currently under regulatory review by the US Food and Drug Administration.
Alere 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 diagnostic developers use in point-of-care immunoassay- and nucleic acid-based testing platforms.
However, Alere has quickly identified molecular diagnostics as a priority, and in 2012 it disclosed it was developing a pair of molecular testing platforms: the Alere i and the Alere Q.
The Alere i system has a small footprint and uses isothermal amplification technology, removing the need for thermal cycling or sample purifications steps and making the platform conducive to rapid, near-patient testing.
Mike Musgnug, vice president of global marketing for infectious disease at Waltham, Mass.-headquartered Alere, told PCR Insider in an email today that the Alere i system is designed to work with one of two isothermal amplification technologies — nicking enzyme amplification reaction (NEAR) or recombinase polymerase amplification (RPA) — that Alere acquired in 2010 along with Ionian Technologies and TwistDx, respectively.
The influenza A & B test uses the NEAR method, Musgnug said. This 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.
Future tests may use either NEAR or RPA, which 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.
Alere established the clinical performance of Alere i Influenza A & B in a multi-center, prospective study conducted at eight US trial sites during the 2012-2013 respiratory season. A total of 571 prospective nasal swab specimens collected from patients of all ages presenting with flu-like symptoms were evaluated with the Alere assay and compared to viral culture. All discrepant results were subsequently tested on an unspecified FDA-cleared RT-PCR assay at a central testing laboratory.
Data from the trial showed that Alere i Influenza A & B showed 99.3 percent sensitivity and 98.1 percent specificity for influenza A detection; and 98.9 percent sensitivity and 99.6 percent specificity for influenza B.
Musgnug said that no sample preparation or pre-treatment is necessary, adding that a user "simply adds the sample to the sample receiver," which accepts untreated nasopharyngeal swabs or viral transport medium. He also noted that Alere i's "simplicity and cost-effectiveness make it well suited for use in physician offices, emergency departments, and urgent care clinics as well as centralized laboratories."
Alere is also developing Alere i tests for Group A Streptococcus, Clostridium difficile, respiratory syncytial virus, and chlamydia/gonorrhea. The company has not provided a timeline for the development of these assays.
Meantime, Alere's second molecular platform, the Alere Q, remains under development. This system is designed with molecular testing in resource-poor areas of the world in mind. The company has disclosed that it 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 company calls "proprietary competitive reporter amplification" technology.
The company did not provide an update this week on the development timeline for that platform. However, in an October conference call recapping the company's Q3 2013 financial results, CEO Ron Zwanziger noted that the platform "is nearing rollout for the first product target, a combined HIV-1/2 detection and viral load monitoring test;" and that the system will be made available in the market in a limited fashion prior to CE regulatory approval, which is expected in the first half of this year.
Alere plans to expand Alere Q's menu to address additional therapeutic areas such as hepatitis C virus and tuberculosis. In March Alere said it had been awarded a grant of up to $21.6 million and debt financing of up to $20.6 million from the Bill & Melinda Gates Foundation to support the development and scale-up of a molecular point-of-care TB assay for the platform.