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Enzo Clinical Labs Gets NY State Approval for HBV Assay

NEW YORK — Enzo Clinical Labs has received approval from the New York State Department of Health (NYSDOH) for its AmpiProbe HBV viral load monitoring assay for hepatitis B virus, the company's parent Enzo Biochem said today.

With the approval, the test can now be offered to residents of the state.

The assay is based on the firm's AmpiProbe nucleic acid detection technology, which uses a combination of fluorescent reporter-labeled primers and quencher-labeled primers to amplify DNA. According to Farmingdale, New York-based Enzo Biochem, the assays are compatible with open PCR platforms and can be validated with existing instrumentation.

“With this latest New York State approval, Enzo continues to successfully execute on its plan to provide a cost-effective, comprehensive menu of assays and diagnostic tests addressing the sexually transmitted infections market for women and men," Enzo Biochem CEO Elazar Rabbani said in a statement.

In July, Enzo Biochem received NYSDOH approval for its AmpiProbe gonorrhea and chlamydia tests with oral and rectal specimens. In late 2017, the company received approval from the agency for its  multiplex AmpiProbe STI panel covering 16 common sexually transmitted infections.