Healthcare Industry News: SARS-CoV-2
News Release - June 9, 2020
FDA Grants EUA to Rapid COVID-19 Antibody Testing Product Distributed by Premier Biotech
Product manufactured by Hangzhou Biotest Biotech is confirmed by the National Cancer Institute to have specificity and sensitivity exceeding FDA requirementsPremier Biotech plans to ramp up distribution of the product in all 50 U.S. states, enhancing U.S. COVID-19 antibody testing infrastructure critical to effective response efforts
FDA letter of authorization located here https://www.fda.gov/media/138657/download
MINNEAPOLIS, June 9, 2020 -- (Healthcare Sales & Marketing Network) -- Premier Biotech, Inc. ("Premier Biotech" or "the Company") announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to the COVID-19 IgG and IgM rapid test manufactured by Hangzhou Biotest Biotech, Co., Ltd. ("Biotest") and distributed by Premier Biotech, used for the qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in whole blood, serum, or plasma. The product includes a complete testing kit that produces reliable results in 10 minutes.
"The FDA's decision to grant Biotest's product EUA is great news for communities across the U.S. that continue to struggle to access adequate COVID-19 testing, which healthcare experts agree is essential to successful recovery from the COVID-19 crisis," said Premier Biotech CEO Todd Bailey. "Premier Biotech is proud to leverage our national distribution expertise and relationship with Biotest to provide U.S. healthcare professionals and their patients access to fast, reliable antibody testing."
"As the grant of EUA confirms, the National Cancer Institute has verified this product exceeds the 95% specificity and 90% sensitivity standards set by the FDA. Undoubtedly, this product is in clear alignment with Premier Biotech's rigorous compliance standards and commitment to distributing high-quality testing solutions. We will continue to follow the regulatory guidelines closely as we distribute the product for emergency use to authorized laboratories nationwide."
About Premier Biotech Inc.
Premier Biotech Inc. is a leading provider of rapid drug testing devices and distributor of a COVID-19 antibody testing product that has been granted Emergency Use Authorization by the U.S. Food and Drug Administration. The company offers a comprehensive line of proprietary drug testing products. Premier Biotech Labs, LLC, located in Minneapolis, provides high complexity testing and customized laboratory services for toxicology testing in criminal justice/corrections, clinical medication monitoring; and corporate workforce clients. Premier Biotech Labs holds both CAP (College of American Pathologists) Forensic accreditation and Clinical Laboratory Improvement Amendments (CLIA) certification, each of which requires the highest level of quality control standards and rigorous protocol adherence, including complete chain of custody and frequent inspections. More information at www.premierbiotech.com
Source: Premier Biotech
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