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NYS Department of Health Approves OpGen Gene Test

NEW YORK (GenomeWeb) – OpGen announced today that the New York State Department of Health has approved its Acuitas MDRO Gene Test for use by doctors and healthcare providers in the state.

Acuitas provides information on the presence of 10 MDRO resistance genes in a single sample from a patient. Approval of OpGen's CLIA laboratory to perform testing in New York includes approval for the complete OpGen MDRO testing workflow, including gene testing on perianal swabs and clinical isolates.

The MDRO genes are associated with carbapenem-resistant Enterobacteriaceae, extended spectrum beta-lactamase, and vancomycin-resistant Enterococci organisms, and are often linked to antibiotic-resistant infections. Health providers can use the test results to identify patients colonized with organisms expressing the drug-resistant genes or who are actively infected.

"By making our testing available to NY State healthcare providers, we hope to help combat the rising superbug multidrug resistant pathogen issue," OpGen CEO Evan Jones said in a statement.

OpGen announced in June that it had signed a supply agreement with Thermo Fisher Scientific to combine its Acuitas test with Thermo Fisher's real-time PCR solutions.