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Kalorama: After First Molecular Rapid Test Approval, Expect More.

NEW YORK, Jan. 21, 2015 /PRNewswire/ -- Kalorama Information says that the broad-use approval of the first rapid diagnostic test for influenza with a molecular basis demonstrates the potential for molecular POC marketplace predicted in the firm's report last year. Alere(TM) i Influenza A & B received a CLIA (Clinical Laboratory Improvement Amendments) waiver. The healthcare market research publisher predicted the trend of decentralized testing approaches like Alere's product in its report, The Market and Potential for Molecular Point of Care Diagnostics .

Kalorama's report on molecular point of care is available at: http://www.kaloramainformation.com/Potential-Molecular-Point-8028587/.

Alere Inc. announced that the U.S. Food and Drug Administration (FDA) granted CLIA waiver for its Alere(TM) i Influenza A & B test, which allows for broad use by healthcare providers, ranging from hospitals and physician offices to clinics and other healthcare settings. (Alere's announcement: http://news.alere.com/~/media/Files/A/Alere-Newsroom-V2/press-release/Alere_i_CLIA_Approval_US_Press_Release_1_7_2015_FINAL.pdf).

The product is currently the only molecular test to detect and differentiate influenza A and B virus in under 15 minutes.

"Kalorama had indicated last year that POC MDx technologies would hit market near-term, and now this has been realized," said Bruce Carlson, Publisher of Kalorama Information. "There are dozens of other companies that are also working on Molecular POC tests, so I'd expect to see more approvals and a competitive marketplace."

The Alere i test was cleared for marketing by the FDA in June 2014, and was made available in September for health facilities and laboratories licensed to conduct tests of moderate complexity under the CLIA program. With CLIA waiver, the test will be available in a significantly broader range of healthcare settings.

Molecular testing involves the extraction and analysis of DNA or RNA strands to detect sequences associated with viral and bacterial causes of infections. The company says that unlike polymerase chain reaction (PCR) testing, thier proprietary isothermal nucleic acid amplification technology (iNAT) does not require lengthy and complex thermo cycling or DNA purification, and can therefore deliver PCR-caliber results faster. The company said the clinical performance of Alere i Influenza A & B was established in a multi-center study conducted in the U.S., in which 630 nasal swab specimens were evaluated with Alere i, and compared to an FDA cleared Real-Time PCR (RT-PCR) assay.

Kalorama believes that influenza is not the only area where a rapid product can succeed.

"Now that the first molecular POC has been CLIA-waived, it's a question of whose test will be next," said Carlson. "There are market opportunities in HIV, warfarin sensitivity, sepsis and other areas where actionable results matter."

The report, The Market and Potential for Molecular Point of Care Diagnostics , details these areas and the companies that have products in development. The report discuses important platforms and the status of products, reviews deals made in the market and profiles companies in this market. It also provides insight into the potential market for these products. Information for this report can be found at: http://www.kaloramainformation.com/Potential-Molecular-Point-8028587/.

About Kalorama Information Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog at www.kaloramainformation.com.

Contact: Bruce Carlson (212) 807-2622 bcarlson@kaloramainformation.com www.KaloramaInformation.com

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