The New York State Department of Health has granted conditional approval for use of Enzo Clinical Labs’ AmpiProbe Candidiasis assay, the company’s second test aimed at the rapidly expanding women’s health market and the third to be approved utilizing one of the company’s proprietary technology platforms.
AmpiProbe Candidiasi is a multiplex assay designed to identify the presence of five of the most common species of candida from a single vaginal swab. Industry estimates put the number of tests performed for the identification of candida at more than 10 million per year in the U.S. alone.
It is also estimated that moe than 70 percent of women will develop a candida infection during their reproductive lifetime. While an independent assay, it will also serve as a component of a comprehensive women’s health panel currently under development, according to the company. Additionally, Enzo scientists will deliver a technical presentation at the College of American Pathologists (CAP) annual meeting in September.
The approval of AmpiProbe Candidiasis follows a similar approval granted to Enzo last November by the New York State Department of Health of AmpiProbe HCV for the quantitative detection of hepatitis C virus and prior to that, Enzo’s FlowScript HPV assay. The FlowScript assay, approved in February 2015, is based on proprietary technology allowing the multiplexed analysis of cellular function in a single assay via the simultaneous examination of each and every cell in a given sample.
It is now being used to assist physicians in better evaluating the progression of abnormal pap smears toward cervical cancer. These assays are now being offered by Enzo Clinical Labs to physicians, and also are currently being marketed nationwide, as will AmpiProbe Candidiasis.
The newly approved assays are the forerunners of a comprehensive line of diagnostic products under development by Enzo to address the needs of clinical laboratories that are often locked into closed-system contracts with molecular diagnostic suppliers that, with ever-declining reimbursements, reduce or even eliminate operating margins, the company said.
Products in the company’s development pipeline include an extensive line of assays for detection of numerous women’s health infectious agents as well as for use in the identification of pathogens for other markets. Enzo also reported that it expects to roll out a line of products designed to aid pathologists in distinguishing the characteristics of various tumors from biopsy specimens using technology developed by its scientists. The molecular-based products are targeted at a market estimated to be in excess of $3 billion worth of laboratory service revenue.