NEW YORK – Enzo Biochem said today that it has received New York State Department of Health approval for use of its AmpiProbe Neisseria gonorrhoeae and Chlamydia trachomatis (CT/NG) nucleic acid amplification tests with oral (pharyngeal) and rectal specimens.
The approval enables Enzo to offer the test to residents of New York state, and adds to the company's menu of molecular diagnostic tests for sexually transmitted infections (STIs).
Enzo already has NYS DOH approval for its AmpiProbe STI panel, a multiplex nucleic acid amplification test for 16 common STIs including CT/NG, Candida, Ureaplasma, Mycoplasma, and bacterial vaginosis using a single vaginal swab. The latest NYS DOH approval expands the company's CT/NG testing to samples from multiple relevant body sites.
Enzo also noted that it provides molecular testing from anal and genital samples for human papillomavirus, as well as tests for STIs such as HIV and herpes simplex virus. Given this rapidly expanding STI testing menu, the company said today that it is launching a new consumer-facing business model for these tests.
"We believe the time is right to launch a direct-to-consumer testing application where, in permitted jurisdictions, patients can avail themselves of these tests simply and effectively, with privacy, but without the unnecessary red tape and oversight of insurance carriers and shifting reimbursement policies," Enzo President and CFO Barry Weiner said in a statement.
"We are working with a number of medical professionals, urgent care facilities and other intermediaries to launch this business this fiscal year," Weiner said. "We will offer a comprehensive series of all STI molecular tests across all relevant sites of infection as a complete package of services."
In addition, New York-based Enzo reiterated its previously stated intent to launch a "lab-to-labs" business model wherein the company will serve as a central testing facility for smaller labs.
Furthermore, Enzo today stated its intent to expand its laboratory service offerings to clinical research organizations, academic research institutions, and the pharmaceutical industry.