August 06, 2020 – OraSure (Bethlehem, PA) along with its quarterly financial results, announced what the company is doing to help the industry combat the COVID-19 pandemic. The company says it is well positioned to support multiple modes for COVID-19 testing, including PCR/molecular, antigen, and antibody testing.
To support capacity building for the company’s existing products and anticipated new product launches, OraSure says it is “executing on a series of capital investments intended to ensure scaled-up capacity to meet both current and anticipated substantial COVID-19-related demand.”
Use of existing oral fluid collection devices in molecular COVID-19 testing generated $8.5M in revenue in the second quarter, OraSure says. In the second quarter alone, devices from OraSure’s DNA Genotek subsidiary, including the ORAcollect RNA collection kit, OMNIgene ORAL saliva collection device, and Oragene Dx device, were included in U.S. Food and Drug Administration (FDA) Emergency Use Authorizations (EUAs) granted to four customers.
The EUAs granted to Clinical Reference Laboratory (CRL), Biocerna, P23 Labs and Phosphorous enable the company’s devices to be used for both supervised and unsupervised COVID-19 sample collection with their EUA assays for the detection of SARS-CoV-2.
OraSure’s devices are also currently being used as part of several back-to-school and back-to-work programs across the country. The company expects one or more of its products to be included in several additional EUAs to be granted in the near future.
Additionally, the company’s OraQuick Coronavirus Rapid Antigen Self-Test is on track for EUA submission and subsequent launch in the fourth quarter of the year. OraSure is developing a rapid antigen self-test, designed to produce a result for active COVID-19 infection within minutes, with no instrumentation needed to interpret the results and no need to transport samples to a lab for processing, enabling the detection of COVID-19 infection anytime, anywhere.
OraSure SARS-CoV-2 Antibody test is also expected to launch in the fourth quarter. The company is developing an Enzyme-Linked Immunosorbent Assay (ELISA) using oral fluid to detect human anti-SARS-CoV-2 antibodies that would enable specimen collection in any location, promoting social distancing. The test would utilize the Company’s existing OraSure oral fluid specimen collection device. OraSure has completed the final product design and this test is currently in human clinical testing.