Pinnacle IVD (Pinnacle) is pleased to announce the addition of the CovID Rapid Antigen Detection Test (RAD) to its existing diagnostic test product line, which includes the Pinnacle CovID NEO IgG/IgM Antibody Test (NEO) and the second generation FIT Colon Cancer Test. The RAD is one of the first point of care antigen tests that requires no additional laboratory equipment and provides highly accurate results in just 15 minutes. Pinnacle has notified the US Food and Drug Administration (FDA) through pre EUA format that it intends to submit an Emergency Use Authorization (EUA) within 10 days. CovID RAD will play a pivotal role in America’s fight against COVID-19 by providing quick, easy detection of SARS-CoV-2 infections.
As leaders in colon cancer screening and other in-vitro diagnostics, Pinnacle has once more jumped to the forefront of the medical device industry, by pairing the NEO and RAD with HIPAA compliant, cutting-edge, smartphone technology. This pairing provides anonymized testing data, real-time intelligence reports and streaming analytics to healthcare providers and health agencies, including the Center for Disease Control and Prevention (CDC).
“Our team is working collaboratively with strategic partners and the FDA to provide the testing protocols and risk mitigation strategies to ensure safe and effective use of our COVID-19 testing solution,” said Charlie Balentine, President of Pinnacle IVD Corporation. “By pairing our point of care antigen and antibody tests with a technology platform, we can provide healthcare providers and policymakers with the data they need to make informed decisions. We’re also taking steps to scale our US and global manufacturing capacity to meet the overwhelming demand. We look forward to doing our part to get America back to work and our children back to school safely.”
Pinnacle is working closely with the FDA and their legal counsel, Foley & Lardner LLP to obtain Emergency use Authorization from the FDA. Pinnacle has partnered with Syntactx Clinical Research Services and George Mason University to perform additional clinical studies.
Source: Company Press Release
