Report: Molecular Point of Care Testing Systems Now Reality with Two 2015 CLIA Waivers
NEW YORK, June 10, 2015 /PRNewswire/ -- Kalorama Information says that with two 2015 CLIA waivers, molecular point of care testing is no longer a speculative concept. Fast and relevant molecular tests are coming to hospitals and physician offices, according to healthcare market research publisher that specializes in in vitro diagnostic markets. Kalorama notes that with the approvals of Alere's i Influneza A+B and Roche's LIAT PCR Step A test, molecular testing can reach a new venue – at the site of patient care where results can be utilized by the treating physician.
"Molecular POC is no longer close. It is here," says Lucy Sannes of Sannes&Associates, who authored a report for Kalorama on molecular point of care. "And our report lists many other companies that have molecular point of care products in development."
That report, The Market and Potential for Molecular Point of Care Diagnostics, can be purchased at http://www.kaloramainformation.com/redirect.asp?progid=87534&productid=8028587.
In January, Alere announced CLIA waiver of Alere's 15-minute molecular test for influenza. This test was already FDA-cleared and CE marked. It is now also CLIA-waived, meaning that it can be used in all physician's office laboratories in the U.S. Roche announced May 19 that the U.S. Food and Drug Administration (FDA) has granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas® Strep A test for use on the cobas® Liat System. It is the first CLIA-waived PCR test to detect Strep A in throat swab specimens in 15 minutes. The Liat system was originally developed by IQuum. Roche acquired IQuum in April 2014. CLIA waiver allows for broad use of these molecular tests by healthcare providers in non-traditional laboratory sites, including physician offices, emergency rooms, health department clinics, pharmacy clinics and other healthcare facilities.
Kalorama Information's report details at least 50 companies that are involved in molecular point of care testing.
This report, The Market and Potential for Molecular Point of Care Diagnostics, offers a quantitative assessment of the molecular diagnostic market, and of the point-of-care (POC) testing market, and then looks at the emerging field of molecular diagnostic POC testing. Many companies are developing molecular diagnostic platforms and assays that are designed to for near-patient or POC testing, and the earliest of these systems are starting to reach the market. The initial market focus for most of these companies is on infectious disease testing, where rapid test results generate important actionable information that physicians can use to make treatment decisions. For more information visit: http://www.kaloramainformation.com/redirect.asp?progid=87534&productid=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. 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 at www.kaloramainformation.com.
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SOURCE Kalorama Information
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