Jan 30, 2018   SOURCE: PR NewsWire

In Severe Flu Season, a Chance for Molecular Point-of-Care Testing to Make its Case

ROCKVILLE, Md., Jan. 30, 2018 /PRNewswire/ -- The CDC has labeled this year's flu season severe, meaning more patients will be at doctor's offices and clinics with symptoms. However, at some of these venues, there will be a new weapon this year: systems that find flu virus at the molecular level, find it quickly and don't take up much space. That's according to Kalorama Information, a New York City-based researcher that deals with IVD test systems. With cases on the rise right now, the 2017-'18 flu season has yet to reach its peak, surpassing that of the 2012-'13 season, and young people are being hit particularly hard. Federal health officials warned Friday that this year's flu outbreak is more severe than any other since the 2009 swine flu pandemic, and that its intensity is still increasing. The finding was made in the firm's most recent study, The Market and Potential for Molecular Point of Care.

"There are now systems on the market that were not even conceived of in 2009 when H1N1 struck," said Bruce Carlson, Publisher of Kalorama Information. "These new tests - particularly those from Alere, Roche, Cepheid and bioMerieux are going to be have a better case than they would have last year."

That's important, said Carlson, because molecular point-of-care systems need to demonstrate cost effectiveness due to their current higher pricing. In a time of increased demand for testing, however, they have an argument. There are a few options that lend themselves to better point-of-care solutions:

    --  RIDT: Kalorama Information says the typical way to diagnose an infection
        by the influenza virus in emergency facilities is with lateral flow
        immunochromatographic assays; they're simple, they're quick, and most
        importantly, they're inexpensive. The problem with these tests (also
        called rapid influenza diagnostic tests, or RIDTs), however, is that
        their sensitivity has been deemed "sub-optimal" by the Centers for
        Disease Control: in a letter to the New England Journal of Medicine, one
        of their studies evaluated one such test at 51%, and cited in the letter
        was a study that found another RIDT's sensitivity rate to be a
        staggering 27%. While the latter figure seems to be an extreme example,
        a meta-analysis conducted in 2012 found that RIDTs had, on average,
        sensitivities of 62.3%.


    --  PCR: The gold standard for diagnostics is real-time PCR, but this has a
        few things going against it. Actually, it's the diametric opposite of
        RIDTs: PCR is complex, requiring a lot of preparation and technical
        knowledge to operate; PCR is time-consuming, because of the preparation
        and the complexity of its mechanism; PCR is also expensive because of
        its complexity, but also in terms of patient isolation and management,
        because of the time it takes to get results.
    --  Molecular POC: So for a few years now, big biotech firms have been
        working on better solutions, employing nucleic acid amplification
        techniques that make PCR so accurate and engineering them into
        relatively tiny and simple packages, and as it turns out, they really
        are much better than RIDTs, and much faster and simpler than PCR. The
        devices are cartridge-based, requiring minimal input from the user; they
        turn results out in well under an hour, with most in the 15-30 minute
        range.

Of these, molecular POC blends speed and accuracy.

The molecular point-of-care market, consisting of systems with molecular capability used in decentralized test environments is driven by influenza testing and augmented by other respiratory testing, according to Kalorama's report. Kalorama Information's most recent study, The Market and Potential for Molecular Point of Care, details the markets for mPOC testing in influenza and in several other test categories. The report is available at: https://www.kaloramainformation.com/Potential-Molecular-Point-Care-11403174/

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. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.

We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog on our company website.

Press Contact:
Bruce Carlson
212 807 2262
bcarlson@marketresearch.com

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SOURCE Kalorama Information