NEW YORK – Enzo Biochem said on Tuesday that its wholly owned subsidiary, Enzo Clinical Labs, has received approval from the New York State Department of Health for its CT/NG/TV tests using liquid-based cytology sample collection on its proprietary GenFlex platform.
The GenFlex is a sample-to-result molecular diagnostic platform that includes sample collection, processing, amplification, and detection, Enzo said. Compared to other proprietary platforms on the diagnostic testing market, the company noted that the GenFlex platform can save clinical labs 30 percent to 50 percent over current closed systems.
GenFlex currently addresses the $450 million annualized global market for the detection of chlamydia trachomatis (CT), neisseria gonorrhoeae (NG), and trichomonas vaginalis, and supports other tests in women's health. Enzo said it is developing extensions to the platform, which could eventually make it capable of addressing the entire $7 billion molecular diagnostic market.
"We are extremely pleased to announce this approval of GenFlex as we remain on track on our development program," Enzo CEO Elazar Rabbani said in a statement. "Enzo's previously validated Ampiprobe detection system has been transformed into a complete end-to-end solution, GenFlex. This platform is a direct response to the critical industry need to offer lower-cost solutions in the dramatically shrinking reimbursement rate environment as we can now offer users cost savings … and the scalability necessary for a full commercial roll out."