OpGen Acuitas ® MDRO Gene Test Approved by NY State Department of Health
GAITHERSBURG, Md., July 12, 2017 -- OpGen, Inc. (NASDAQ:OPGN) announced today that the New York State Department of Health (NYSDOH) has approved the Acuitas® MDRO Gene Test for use by physicians and healthcare providers in the state. The approval of OpGen’s CLIA laboratory to perform testing in New York State includes approval for the complete OpGen MDRO testing workflow, including MDRO gene testing on perianal swabs and clinical isolates. The NYSDOH regulates and oversees clinical diagnostic laboratories that test specimens from the state residents.
The Acuitas MDRO Gene Test is a CLIA lab-based test able to provide information regarding the presence of ten MDRO resistance genes from one patient specimen. The ten drug-resistant genes identified by our Acuitas MDRO Gene Test are associated with CRE, ESBL and VRE organisms, and are gastrointestinal organisms frequently associated with antibiotic-resistant infections. The test results can be used by healthcare providers to identify patients colonized with organisms expressing the drug-resistant genes or who are actively infected.
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