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Alere's $12.9M BARDA Contract to Fund Next-gen Isothermal MDx Platform, Flu Test

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NEW YORK (GenomeWeb) — Although Alere launched the Alere i molecular diagnostic platform and influenza assay only three months ago, the company announced this week that a three-year contract worth up to $12.9 million from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority will be used, in part, to develop the next generation of the platform and test.

The platform launched in June with a 510(k)-cleared influenza A/B test, as covered in PCR Insider.

In an email with PCR Insider this week, John Wisson, director of new product development for acute infectious diseases at Alere's UK offices, said the next generation of the Alere i instrument and the influenza test will be "provided at a significantly lower cost, making it even more accessible for use in any environment." The price of the current platform is $8,500, with a per-test cost of around $80.

The company initially launched Alere i in Europe, and early customer feedback has been "very complimentary in terms of benefits to patient outcomes and length of stay in hospital," Wisson said.

The system was also recently retrospectively validated on respiratory specimens from children, where it showed high sensitivity and specificity compared to viral cell culture and RT-PCR. A study on frozen specimens collected from adults in the 2012 flu season was also published recently, as was a prospective, multicenter clinical evaluation.

Like the current version of the platform, the next generation will employ isothermal amplification technologies.

The system is designed to work with two of these — the nicking enzyme amplification reaction (NEAR) or recombinase polymerase amplification (RPA) — that Alere acquired in 2010 along with Ionian Technologies and TwistDx, respectively.

The current Alere i flu assay uses the NEAR technology, but the platform "has the potential to offer both NEAR and RPA," KC McGrath, respiratory product manager at the Waltham, Mass.-headquartered company, noted in June.

"Certain unique aspects of the isothermal RPA biochemistry lend themselves to this next-generation platform," Wisson said this week, including "high tolerance to thermal fluctuations, fluidic simplicity and inhibitor dilution, multiple established detection formats, and the option of nested amplification."

Alere will continue to deploy both of the isothermal technologies that it owns "to drive molecular performance with reduced complexity that is truly deployable in the POC segment," Wisson said.

The company is also developing more tests to run on the Alere i platform. A Group A Strep assay is expected to launch in the first quarter of 2015 in both the US and Europe, Wisson said, and Alere is planning to place a minimum of eight assays on this platform within the next three years.

He added that the company currently has multiple sites doing evaluations in both the hospital and the physician office — the "moderately complex" environment for which the company hopes to obtain CLIA waiver. These customers have been "impressed with the ability of Alere i to provide a molecular result in such a rapid format," he said.

The company has now submitted a CLIA waiver on the Alere i influenza A/B test to the US Food and Drug Administration, and "is currently working with the agency," Wisson said.

Alere i will be showcased at the upcoming Infectious Disease week in Philadelphia, where the company will also be presenting a poster on the Alere i Strep A test.

Meanwhile, the company's quantitative isothermal platform, Alere q, received CE-IVD marking in July, Wisson said. On that platform, Alere will launch three HIV products.

The Alere q HIV 1/2 Detect test is intended for early diagnosis in infants as well as diagnosis of acute HIV infections in high-risk adult populations. The company is also developing an HIV viral load test for whole blood as well as one for plasma.

"The Detect test is submitted for CE-IVD and we expect an outcome before the end of the year," Wisson said, adding that the company has also submitted for World Health Organization prequalification. Meantime, Alere plans to begin commercial sales of the assay for the 21 high-prevalence countries in Sub-Sahara Africa in the first quarter of 2015, and expects to start sales in Europe and Asia in the second half of 2015. Viral load-related testing activities will also start in Africa, although the timeline for this remains to be determined, he said.

The BARDA contract was the result of two years of discussion with that agency regarding Alere i's strengths and capabilities, "to demonstrate why Alere is perfectly placed to deliver a low-cost rapid molecular CLIA-waived flu test," Wisson said.

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