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COVID-19 Test Kits offered by Confirm BioSciences receives FDA Authorization (EUA)

Published on: June 1, 2020

Written by: Confirm BioSciences.

As a preferred provider, Confirm BioSciences will have an ample supply of COVID-19 IgG/IgM Rapid Test kits for medical professional use in June

SAN DIEGO, June 1, 2020 /PRNewswire/ — Confirm BioSciences, a leading provider of comprehensive screening tools and solutions, today announced that the U.S. Food & Drug Administration (FDA) has authorized emergency use of its COVID-19 IgG/IgM Rapid Test kits. The tests offered by Confirm BioSciences are manufactured by Healgen Scientific, a subsidiary of Zhejiang Orient Gene Biotech. The FDA authorization and preferred provider status mean Confirm BioSciences will have an ample supply of test kits for medical professional use starting in early June.

The Emergency Use Authorization is significant because it increases the availability of COVID-19 tests to the medical community. Confirm BioSciences will have millions of tests available, enough to satisfy existing pre-orders and future orders. Infectious disease experts say testing is a key component of an effective strategy to control the spread of COVID-19. As part of the FDA review, a National Institutes of Health (NIH) study comparing rapid test kits found that the COVID-19 Rapid Test demonstrated excellent performance. Once finalized, these data will be published as the NIH focuses on four key research priorities to combat the spread of the virus.

“We have received positive feedback on the test from our customers and independent studies, so the FDA Emergency Use Authorization validates what we already knew from real-world clinical applications,” said Albert Berger, Chief Executive Officer, Confirm BioSciences. “This pandemic is an enormous challenge for medical professionals and everyone else, and as a major distributor, we’re proud to do our part to increase testing capacity so that healthcare professionals can help contain the spread of the virus.”

An easy-to-use test kit that provides results in just 10 minutes, COVID-19 IgG/IgM Rapid Test kits are designed for use with whole blood, serum or plasma samples. With a high degree of accuracy, the kits detect IgM that may appear in blood within 3-5 days following incubation and IgG that appears as soon as 1-2 weeks. The tests are authorized for prescription use only for use in high or moderately complex CLIA laboratories. The kits have a shelf life of 24 months from the date of manufacture and can be stored at room temperature or in a refrigerator.

If you are a medical professional or supply medical professionals or medical facilities, please click here to learn more about our COVID-19 IgG/IgM Rapid Test kits. For additional information on coronavirus testing and resources, please visit Confirm BioSciences Covid-19 Resources.

About Confirm BioSciences

Confirm BioSciences is a leading provider of high-quality, comprehensive screening tools and solutions across the full spectrum of health and wellness. With core competencies in testing drugs of abuse and broader health metrics, Confirm is dedicated to providing its customers with meaningful, actionable information. The company’s product portfolio ranges from instant and lab-based testing solutions for drugs of abuse, including HairConfirm® and DrugConfirm®, to HealthConfirm®, a line of testing solutions for health and wellness, with results delivered in insightful user-friendly reports. As an industry authority, Confirm educates and empowers its customers, and supports initiatives that create drug-free and healthy homes, workplaces and communities. The company is headquartered in San Diego, California. For additional information, visit confirmbiosciences.com.

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