Pinnacle Plans to Scale U.S. Manufacturing Capacity to 25 Million Tests Per Month
Cost-Effective 15-Minute Rapid Antigen Test Demonstrates 100% Specificity for COVID-19 Detection When Compared with RT-PCR
ENGLEWOOD, CO / ACCESSWIRE / September 8, 2020 / Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs announced today that the Company has signed an agreement to distribute the Pinnacle CovID RAD Rapid Antigen Detection Test worldwide. The rapid antigen test, which delivers results in fifteen minutes, tests for the presence of the SARS-CoV-2 virus antigen via a nasopharyngeal sample and can be conducted without the use of laboratory equipment.
Pinnacle IVD Corporation plans to scale U.S. manufacturing capacity for the CovID RAD Rapid Antigen Detection Test to 25 million tests per month.
The CovID RAD Rapid Antigen Detection Test was developed by U.S.-based Pinnacle IVD Corporation, a leader in colon cancer screening and other in-vitro diagnostics. The Pinnacle CovID RAD Rapid Antigen Detection Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2 in nasopharyngeal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider.
In a study of 162 patients the CovID RAD Rapid Antigen Detection Test demonstrated 100% specificity and 84.3% sensitivity when nasopharyngeal swab results were compared with RT-PCR. Positive predictive value of the test was 100%, and negative predictive value was 96.3% in the study. These results have been included in the company's Emergency Use Authorization submission to the U.S. Food and Drug Administration.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, "We continue to find ways to help in the COVID-19 fight. This high-performing antigen test - that directly detects the presence of the COVID-19 virus antigen - requires no laboratory equipment and enables medical professionals to deploy large-scale testing in a rapid and simple-to-use format. Antigen testing has become a primary screening tool as we seek to decentralize testing and speed up turnaround times."
Mr. Disbrow continued, "In many instances patients are waiting multiple days to receive their COVID test results, so having a simple, fifteen-minute test helps open up a key bottleneck in the testing process. We're pleased to be partnering with Pinnacle IVD Corporation and believe this test can help curtail the spread of COVID-19 as we begin to reopen the global economy."
Charlie Balentine, President of Pinnacle IVD Corporation, stated, "We are pleased to have Aytu BioScience as our distribution partner for the CovID RAD test. Pinnacle worked quickly to develop this test and is poised to scale manufacturing capacity substantially in order to meet the high demand for antigen tests. Through this partnership with Aytu we look forward to being a part of the solution in the fight against COVID-19."