EXPLORE THE ADVANTAGES OF UTILIZING U.S. FDA-CLEARED SALIVA COLLECTION DEVICES IN YOUR GENETIC TESTS

Learn about the value that U.S. FDA-cleared Oragene^TM●Dx and ORAcollect^TM●Dx saliva collection devices can add to genetic tests and molecular diagnostics, and gain insights into the regulatory landscape for IVDs and LDTs and the strategic path for bringing genetic tests to market while complying with evolving regulations.

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A faster, more affordable path to discovery

Product with 510(k) clearance

Product with 510(k) clearance (e.g., the Oragene^TM●Dx and the ORAcollect^TM●Dx devices) reduce the time needed to implement devices/assays in prescription or direct to consumer models.

Product without 510(k) clearance

Considerable time and money spent revalidating devices that are not FDA cleared for general use.

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Proven, reliable self-collection at the physician's office or home*
Reduced time and complexity of FDA submissions by leveraging 510(k) clearances
Decreased cost of sample transport, management and storage with ambient temperature DNA stability
Designed to be compact and robust for transport via the postal system, enabling easy access to customers
Increased efficiency and minimal sample handling with a tube format compatible with automated processing
Proven high-quality DNA for use on microarray and sequencing platforms
Comprehensive custom offerings, including branding and fulfillment services

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*The Oragene™•Dx device and ORAcollect™•Dx device direct-to-consumer (DTC) user comprehension studies (K192920 and K212745, respectively) were conducted to support a pre-market submission to the FDA. These studies were conducted to assess the acceptability of saliva samples collected with the Oragene™•Dx or ORAcollect™•Dx devices for a direct-to-consumer application. The objective of the studies was to demonstrate that naive participants comprehend the instructions for use provided with the devices and can successfully provide a saliva sample at home with acceptable quality for use in downstream diagnostic testing applications.

Some DNA Genotek products may not be available in all geographic regions. Check product availability in your region by selecting your location on the website. Full terms and conditions for all DNA Genotek products are available here. DNA Genotek's sample collection devices and nucleic acid stabilization chemistries are protected by issued and pending patents in numerous countries around the world.