November 3, 2022 – OraSure Technologies announced that they received U.S. FDA clearance for its ORAcollect®•Dx saliva collection device for OTC (i.e. direct-to-consumer) use. The device had been previously cleared for prescription use by the FDA. ORAcollect®•Dx joins the Oragene®•Dx product line which previously received FDA general clearance for prescription and OTC use.
This new designation now allows ORAcollect®•Dx devices to be used by OraSure’s commercial partners and legally marketed with their therapeutics or devices in conjunction with their product’s intended use. Both the ORAcollect®•Dx, and Oragene®•Dx devices are designed to be used by an adult at home, without direction from a healthcare professional.
OraSure received this designation through its partnership with Grifols to support screening for alpha1-antitrypsin deficiency (alpha-1) in individuals who may be at risk for alpha-1. Alpha-1 raises patients’ risks for lung disorders and it is estimated that about 3% of COPD patients have alpha-1. Beginning in Q2 2023, Grifols will offer free AlphaID™ At Home Genetic Health Risk Service, supporting alpha-1 screening, that utilize the ORAcollect®•Dx device to help identify individuals at risk. According to the Centers for Disease Control, COPD affects over 15 million people in the United States.
“This clearance represents a major milestone for OraSure as we work in conjunction with our commercial partners to increase access to healthcare,” said Kathleen Weber, President of Molecular Solutions for OraSure Technologies. “With the movement toward precision medicine, we increasingly see the need for genetic testing supporting FDA approved therapeutics as drugs become more specialized for targeted patient populations. This expanded designation now allows us to better support our customers and expands the potential for future indications with the ORAcollect®•Dx device.”