DNA Genotek is pleased to share the news that that the U.S. Food and Drug Administration (FDA) has granted a general use 510(k) clearance for its Oragene®•Dx family of products.
Oragene•Dx is intended for use in the non-invasive collection of saliva samples for in vitro diagnostic testing of human DNA. Oragene•Dx is now the first and only device with general clearance for collection and stabilization of DNA from saliva for use in genetic testing of human germline DNA, 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.
“With this 510(k) clearance, genetic test providers offering diagnostic testing can confidently use our product within their test protocols without having to provide information on Oragene∙Dx device in their FDA submissions,” says Kathleen Weber, Executive Vice President Molecular Solutions.
“This saves time and cost for diagnostic companies that want to leverage an FDA-cleared saliva collection device into their methodologies in addition to, or instead of, collecting blood samples. The clearance reinforces DNA Genotek’s commitment to quality, regulatory compliance – and our customers.”
Want more information on how to work with FDA cleared DNA saliva collection devices for your genetic test offering? Click below or contact us at firstname.lastname@example.org to request sample kits or to learn more about DNA Genotek’s FDA 510(k) cleared collection devices.