OraSure Technologies wholly-owned subsidiary DNA Genotek has secured general use 510(k) clearance from the US Food and Drug Administration (FDA) for its Oragene·Dx family of products.
Oragene·Dx has been designed for the non-invasive collection of saliva samples for in vitro diagnostic testing of human DNA.
It is claimed to be the first and only device with general clearance for collection and stabilisation of DNA from saliva and use in genetic testing of human germline DNA, including prescription or over-the-counter use.
Saliva samples collected using Oragene·Dx are stabilised for use in downstream diagnostic testing applications
Saliva samples collected with the support of Oragene·Dx are stabilised for use in downstream diagnostic testing applications. It can also be transported or stored long-term at ambient temperatures.
Molecular Solutions executive vice president Kathleen Weber said: “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 devices in their FDA submissions.
“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.”
DNA Genotek offers biological sample collection products and end-to-end services for human genomics and microbiome applications.
Oragene·Dx and ORAcollect.Dx product lines are FDA approved saliva-based DNA collection devices for in vitro diagnostic use.
The company also provides research use only products to collect and preserve large amounts of DNA or RNA from multiple sample types.
OraSure Technologies develops, produces and supplies rapid diagnostic tests sample collection and stabilisation devices, and molecular services solutions for the discovery and detection of critical medical conditions.
Earlier this year, Todos Medical agreed to acquire in vitro diagnostics company Provista Diagnostics for an undisclosed sum.-NS Medical Devices