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Dx Focus: OraSure Gets FDA OK for DNA Collection Device; Quest Dengue Test Approved in Brazil


OraSure Technologies said this week that the US Food and Drug Administration has granted it 510(k) clearance for its Oragene Dx collection device.

Oragene Dx is the first and only saliva DNA collection and stabilization device to receive 510(k) clearance, the company said. The all-in-one system is used to collect, stabilize, and transport DNA from saliva. The product is currently used by thousands of academic and research customers in more than 100 countries worldwide. It provides substantial advantages over traditional DNA collection methods such as blood or buccal swabs, including the reliable collection of high-quality DNA samples using a simple, non-invasive method; and the ability to transport and store collected samples for extended periods at ambient temperatures, the company said.

Oragene Dx is suitable for use in FDA-cleared molecular diagnostic applications and was cleared using results from the GenMark eSensor warfarin sensitivity saliva test.

Quest Diagnostics said this week that its Simplexa Dengue molecular diagnostic test kit has been approved for use in Brazil for public and private health labs. The test has been registered with the National Agency of Sanitary Vigilance.

Quest's Focus Diagnostics business developed the test, which runs on the 3M Integrated Cycler and uses RT-PCR to quantitatively detect and differentiate between the four dengue serotypes (viruses DEN1-4). Quest said that the platform can provide results in as few as 60 minutes following sample extraction.

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