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With FDA-Cleared Flu Test, Alere Launches Isothermal MDx Platform for US Clinical Market

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NEW YORK (GenomeWeb) — This week, Waltham, Mass.-headquartered medical diagnostics company Alere received FDA clearance for a new influenza test that can both detect and discriminate nucleic acids of influenza A and influenza B viruses.

The test takes 15 minutes to run and uses an isothermal duplex amplification, thus eliminating the need for a thermal cycler and making the assay suitable for use at the point of care. Alere launched the test earlier this year in Europe. In the US, the company has completed the clinical trials for a CLIA waiver, which it intends to submit in the third quarter.

The new test, called Alere i Influenza A & B, is also the debut assay on Alere's small footprint molecular diagnostic platform, Alere i, which uses an isothermal amplification technology called nicking enzyme amplification reaction, which the company has branded "Molecular. In Minutes."

In an interview with PCR Insider, KC McGrath, respiratory product manager at Alere, said the platform will soon be populated with a menu of clinical tests for pathogens that frequently infect patients, and confirmed that all the assays slated to run on the Alere i platform utilize isothermal amplification technology.

The Alere i platform is the first of a pair of molecular testing platforms Alere announced in mid-2012. The other platform, Alere Q, is under development. It will also be an isothermal molecular platform, but will enable quantitative assays.

"It's an exciting time from our side of things," McGrath said. "It's Alere's first introduction into the molecular world, with more to follow, and we look forward to kind of changing the concept in the marketplace, [and showing] that you can get a highly sensitive, molecular result in minutes."

A prospective clinical trial of the Influenza A & B test used 585 nasopharengyal swabs collected from patients presenting with influenza-like symptoms at eight US sites, and showed 99.3 percent sensitivity and 98.1 percent specificity for influenza A detection; and 97.8 percent sensitivity and 99.6 percent specificity for influenza B compared to viral culture.

McGrath emphasized that the speed of the new platform is what makes it unique. And whereas other isothermal molecular platforms may use lateral flow for detection, a push-button, bench-top design may also appeal to clinics already able to run CLIA waived tests.

"One of the benefits of this product is an actionable result. Traditional PCR takes a while ... so the ability to get that rapid result, in fifteen minutes or less, is really where the clinical value comes into play," McGrath said. "By adding CLIA waiver, it expands the market potential to most physician offices. We know about 30 percent of physician offices right now are moderately complex, so about 70 percent of them are a waived market. It completely expands our market potential there, and [allows] us to get the technology as close to the patient as possible."

However, it is unclear how Alere's new molecular platforms will compete with existing immunoassays. For example, Alere itself markets a few immuno-based influenza diagnostics, including the BinaxNOW Influenza A & B.

The Alere i molecular influenza test "competes with Binax in the sense that they're both rapid," McGrath said. "The key for us moving forward is really redefining that rapid market. When you think of rapid right now you think of immunoassays, lateral flow technology. We sell more lateral flow flu tests than anyone in the world. We'll continue to do that — there's a place for them, and they work really well."

However, he added, "the knock on rapid [immunoassays] has always been … the fact that they're not sensitive enough. That's where the Alere i comes in. The beauty of it — for the clinician, the lab, the emergency room, wherever it's being implemented — is they get the same time to result that … they get with Binax, but they get the confidence and the ability of a molecular assay to amplify and increase the sensitivity and the performance of the test."

According to McGrath, the company expects the test to cost anywhere from the mid-$70 range to $85. The list price for the Alere i platform itself is $8,500, with different options to install it "as we roll out throughout the [flu] season," McGrath said.

The next item on the menu for the Alere i is a Strep A test. According to a press statement, the company has completed clinical trials for this test and will submit it for 510(k) clearance in the third quarter of this year.

"The plan is going to be a very similar roadmap, where we're expecting clearance by the end of the year ... with the CLIA submission waiver going in shortly thereafter," McGrath said.

Alere is also developing tests for Clostridium difficile, respiratory syncytial virus, and a combined chlamydia and gonorrhea test on Alere i.

"Those timelines are a little bit more fluid at this time," he said. "We're targeting next year for most of those, but the plan is to populate this platform with those assays in the near term."

McGrath said the company has had a good response to the flu test so far in Europe. "The market is a little bit different than the US in the volume of testing they do, but the feedback has been incredibly positive," he said. "To run the assay, you need the … Alere i platform. We have not shipped product in the US, so we will obviously see an uptick on that side. In Europe with the launch earlier this year, it's been all uptake, since there has been nothing on this platform prior to that," he said.

PCR Insider reported in January 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. A company official also said at the time that the Alere i Influenza A & B used the NEAR technology.

McGrath confirmed this week that the Alere i flu assay uses the NEAR technology, and, "as for future assays, the platform has the potential to offer both NEAR and RPA." McGrath also noted that the company's quantitative platform in development, Alere Q, is not based on RPA technology.

In late 2013, Alere said it was on target to launch Alere Q outside the US by the end of that year, and the first test on the platform would be an HIV viral load assay. The company also recently received a grant of up to $21.6 million and debt financing of up to $20.6 million from the Bill and Melinda Gates Foundation to further develop it's point-of-care molecular testing platforms for low-resource settings.

In terms of the HIV viral load test, McGrath said, "it is still in the works," but he could not provide an updated timeline at this point.

McGrath said the company now has a multi-pronged plan to market the Alere i and its growing menu of tests. For instance, the company will demonstrate the platform at conferences such as Infectious Disease Week in Philadelphia in September. Alere also plans to work with opinion leaders to publish posters and journal articles.

"Most importantly, we have an incredibly broad sales team, as well as strong distribution relationships," McGrath said. "The beauty of the instrument is to put it into someone's hands, [and demonstrate] such a small footprint, giving you these lab-quality results, that you can put next to the patient. That's going to be one of its attributes — coming into your office, putting it in front of you, and truly showing you how this technology works."

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