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Enzo Biochem Lands NYS Approval for Bacterial Vaginosis Test

NEW YORK (GenomeWeb) – Enzo Biochem announced today that it has received conditional approval from the New York State Department of Health for its bacterial vaginosis (BV) diagnostic panel on the AmpiProbe nucleic acid amplification and detection platform.

The approval means the firm can offer its test to residents of the state of New York.

"This underscores that our extensive product and services pipeline is moving along on schedule. We remain intently focused on developing and offering highly effective and affordable diagnostic products and services as solutions to the increasing financial pressures on the clinical laboratory industry from both diminishing reimbursements and the high cost of goods, particularly in the molecular diagnostic arena," Enzo Chairman and CEO Elazar Rabbani said in a statement.

The panel tests for Atopobium vaginae, Gardnerella vaginalis, Lactobacillus spp, Megasphera spp, and BVAB2. Enzo also offers several other infectious disease tests on the AmpiProbe platform, which have also received conditional approval from the NYSDOH. These include tests for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Candida spp, and Hepatitis C virus. The company also received NYSDOH conditional approval for its FlowScript assay to detect mRNA from human papilloma virus oncogenes E6 and E7 in 2015.

The company is currently developing a panel for the AmpiProbe platform to quantify viral load in serum or plasma specimens, and is building on the HCV assay to develop assays for the detection of Hepatitis B virus and HIV. The company is also developing a line of products designed to aid pathologists in differentiating the characteristics of various tumors from biopsy specimens.