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Co-Diagnostics says coronavirus test shows spotless sensitivity data in independent evaluations

Published: 10:10 01 May 2020 EDT

Drive-thru coronavirus test with person in PPE
Co-Diagnostics is providing in-vitro diagnostic kits to nearly 50 countries and in the US to more than a dozen states

Co-Diagnostics Inc (NASDAQ:CODX) released performance data for its coronavirus (COVID-19) diagnostic test on Friday that showed 100% sensitivity and 100% specificity, the two metrics used to measure accuracy in molecular diagnostic testing.

The data comes from independent evaluations of the company’s Logix Smart test from the India National Institute of Pathology, the Mexican Department of Epidemiology and others.

Results from PathWest Laboratories out of Australia, for instance, showed 100% agreement between Co-Diagnostic’s test with the lab’s in-house results, as well as 100% clinical sensitivity and accuracy.

READ: Co-Diagnostics sees coronavirus test sales jump across the US

Co-Diagnostics chief technology officer Brent Satterfield cited the test’s low limit of detection, meaning its ability to detect the virus even at small concentrations.

"In diagnostics, the limit of detection or LOD is a single metric that helps inform the key metrics of sensitivity and specificity but is not relevant as a stand-alone data point,” Satterfield said in a statement.

“Other metrics that are important are availability, ease of use and throughput. In countries where we have been evaluated against other tests, we have consistently and repeatedly achieved 100% clinical sensitivity and specificity and you can't do better than that.," he added.

Co-Diagnostics is providing in-vitro diagnostic kits to nearly 50 countries and in the US to more than a dozen states. In February, the company was the first in the US to earn a CE mark from European regulators.

In its home state of Utah, the company has supplied tests to TestUtah, a private-public partnership between the nonprofit Silicon Slopes and the state of Utah with the goal of flattening the curve. 

"The level of rigor and expertise at Co-Diagnostics is representative of the amazing Silicon Slopes tech community,” Silicon Slopes executive director Clint Betts said. “We are immensely proud to have them play a key role in the TestUtah initiative and in our mission to expand access to testing across the state."

Aside from its work with the coronavirus, the company has designed, developed and manufactured in-vitro diagnostic tests approved by either the European Community or the Central Drugs Standard Control Organization (CDSCO) in India for tuberculosis, hepatitis B, hepatitis C, malaria, human papillomavirus, Zika, dengue and chikungunya.

Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com 

Follow him on Twitter @andrew_kessel

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