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

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.