NEW YORK (GenomeWeb) – DNA Genotek announced today that it has received 501(k) clearance from the US Food and Drug Administration for its sample collection device, an alternative to buccal swabs that enables makers of molecular diagnostic devices and laboratory developed tests to reduce the time and regulatory burden associated with their FDA submissions.

The device, the ORAcollectDx, is part of DNA Genotek's OrageneDx saliva-based DNA collection and stabilization devices.

To read the full story....

Register for Free.

Already have a GenomeWeb or 360Dx account?
Login Now.

360Dx reports that the US Centers for Medicare & Medicaid Services would cover next-generation sequencing-based cancer panel tests.

The Washington Post reports that a meteorologist is being considered as presidential science and technology advisor.

In PNAS this week: precision medicine strategy to screen for disease risk, genome evolution in Haemophilus influenzae, and more.

Researchers have developed a PCR-based assay to gauge whether manatees are present in waters.