Skip to main content
Premium Trial:

Request an Annual Quote

FDA Clears DNA Genotek's Salivary DNA Collection Device for Dx

NEW YORK (GenomeWeb News) – DNA Genotek announced that its Oragene Dx collection device has become the first salivary DNA collection and stabilization device to receive 510(k) clearance from the US Food and Drug Administration.

DNA Genotek is a subsidiary of OraSure Technologies, which acquired the firm in August. Its lead product line, Oragene, provides an all-in-one system for collecting, stabilizing, and transporting DNA from saliva. FDA clearance of Oragene Dx will provide diagnostic customers the ability to offer a non-invasive alternative to blood collection as a method of gathering DNA samples.

In addition, molecular diagnostic test manufacturers will be able "to streamline their own regulatory submissions and potentially broaden market accessibility for their genetic tests," the Ottawa, Ontario firm said in a statement.

Oragene Dx can be used in FDA-cleared molecular diagnostic applications and was cleared using results from the eSensor Warfarin Sensitivity Saliva Test from GenMark Diagnostics.

The Scan

Follow-Up Data Requests to Biobank Participants Ineffective, Study Finds

An effort to recontact biobank enrollees for additional information reports low participation in a new BMJ Open study.

Study Finds Widespread Transmission of Resistant Bacteria in Vietnam Hospitals

A sequencing study in The Lancet Microbe finds widespread transmission of drug-resistant Escherichia coli, Klebsiella pneumoniae, and Acinetobacter baumannii in two Vietnam ICUs.

Novel Brain Cell Organoids Show Promise for Autism Research

University of Utah researchers report in Nature Communications on their development of brain cell organoids to study SHANK3-related autism.

Study Finds Few FDA Post-Market Regulatory Actions Backed by Research, Public Assessments

A Yale University-led team examines in The BMJ safety signals from the US FDA Adverse Event Reporting System and whether they led to regulatory action.