PLYMOUTH MEETING, Pa., July 7, 2020 /PRNewswire/ -- Proven Pharmaceuticals, LLC, a service provider to the healthcare and life-science industries, announced today that it is the exclusive authorized U.S. distributor of the Clungene® SARS-CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Cassette.
"Hangzhou Clongene Biotech, the company that manufactures this product, has an established track record producing effective diagnostic tests, and we are extremely pleased with the performance of the Clungene® SARS-CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Cassette to reveal the presence of COVID-19 antibodies," Proven Pharma CEO Scott Wise said.
The test has been submitted to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) and is awaiting approval. The FDA is currently allowing the test to be made available in the U.S. as the agency reviews its EUA application.
The FDA is allowing Clungene® SARS-CoV-2 IgG/IgM Rapid Serology Test to be made available under its new policy dated May 4, 2020. (Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency). As required, the completed EUA template and associated documentation were submitted on May 15, 2020 to the FDA. The submission (EUA#201121) included updated validation reports and additional clinical data. Clungene's establishment registration & device number on the FDA's website is 3009414546.
The test, which should be administered by healthcare professionals, produces Rapid Point of Care results in 15 minutes from whole blood drawn with a finger prick. The diagnostic cassette does not require laboratory equipment or instrumentation, and users do not need to ship the sample to a lab. The manufacturer has performed two clinical studies of the test, both of which were submitted to the FDA, and Proven Pharma is in the process of conducting a third trial in the U.S.
Proven Pharma has distributed Hangzhou Clongene Biotech products in the U.S. since 2018. Proven Pharma has performed multiple site visits of the Hangzhou Clongene Biotech facilities for quality assurance and supply chain efficiencies. Founded in 2004, Clongene is registered to sell 24 products in the U.S., according to the FDA, including the Clungene® SARS-CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Cassette.
ABOUT PROVEN PHARMA Established in 2012, Proven Pharma is a service provider to the healthcare and life science industries. The company offers a wide range of solutions that include specialty distribution, comparator sourcing for clinical trials, dedicated inside sales teams, marketing support, digital transformation, and technology consulting. Their solutions are informed by more than two decades of extensive experience across many areas of the healthcare landscape.
In an industry full of uncertainty, Proven Pharma provides confidence to its customers. The company delivers on-time, every time – using recognized best practice and process to ensure safety and compliance every step of the way. Prove Pharma is dedicated to constantly improving its customers' experience so those customers can improve the lives of their patients. The company's success results from the honesty, integrity and dependability of its team.
About Hangzhou Clongene Biotech Hangzhou Clongene Biotech is a high-tech, leading manufacturer of biological raw materials and in vitro diagnostic products. The company has a solid reputation for offering diversified services and superior flexibility to professional distributors and partnering affiliates in the global market.
Founded in 2004, Hangzhou Clongene Biotech is equipped with state-of-the-art ISO 13485:2016 accredited China GMP compliant R&D and manufacturing facilities covering 19,000 square meters in Hangzhou, China. Their products have obtained CE certificates, FSC certificates, and US FDA 510(k) Clearances.