NEW YORK – Enzo Biochem on Tuesday announced that it has received approval from the New York State Department of Health (DOH) for its PCR-based Ampiprobe HPV laboratory-developed test to detect 14 high-risk human papillomavirus variants on its GenFlex molecular diagnostic platform.
The New York State DOH approval represents "another important milestone in our continuing efforts to expand the menu of molecular diagnostics tests available on our GenFlex platform," Enzo CEO Hamid Erfanian said in a statement. Achieving New York State approval leaves it "well positioned for success as we pursue US and international regulatory approvals," he added.
Erfanian said that Enzo expects to make several announcements related to other molecular LDTs this year and provide a timeline for US Food and Drug Administration submissions for regulatory approvals.
The new approval adds HPV to the menu of tests available on GenFlex, which includes COVID-19 PCR and CT/NG/TV.
In February 2020, Enzo Biochem announced it had received approval from the New York State DOH for its CT/NG/TV tests using liquid-based cytology sample collection on the GenFlex platform.