OraSure Technologies announced that its Oragene®•Dx (OGD-610) saliva collection device was included as a component in the De Novo authorization granted by the U.S. Food & Drug Administration to Helix for their Helix Laboratory Platform1, a whole exome sequencing platform. This is the first exome sequencing-based platform authorized by the FDA. Oragene®•Dx is a product of OraSure’s DNA Genotek subsidiary. Oragene®•Dx (OGD-610) was also included as a component in the 510(k) clearance Helix received for its Helix Genetic Health Risk App2 for late-onset Alzheimer’s Disease for over-the-counter use – the first test to be cleared on the Helix Laboratory Platform. In 2020, Oragene®•Dx received U.S. Food and Drug Administration (FDA) general use 510(k) clearance and remains the first and only device with general clearance for collection and stabilization of DNA from saliva for use in genetic testing, including prescription or over-the-counter (direct-to-consumer) use. Saliva samples collected using Oragene®•Dx are stabilized for use in downstream diagnostic testing applications and can be transported and/or stored long-term at ambient temperatures.