Orasure’s Oragene®•Dx Saliva Collection Kit Included in Industry’s First FDA Authorization for Whole Exome Sequencing Platform
January 21, 2021 at 06:00 am
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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.
OraSure Technologies, Inc. provides point-of-care and home diagnostic tests, sample management solutions, and microbiome laboratory and analytical services. The Company's product portfolio is divided into diagnostics products and sample management solutions. Its business consists of the development, manufacture, marketing and sale of diagnostic products and specimen collection devices using its technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types. Its diagnostic products include tests for diseases including COVID-19, HIV and Hepatitis C that are performed on a rapid basis at the point of care, and tests for drugs of abuse that are processed in a laboratory. Its business also includes molecular sample management solutions and services that are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers.