The test is performed on the company's AmpiProbe platform, and the approval expands Enzo's offering of infectious disease tests in New York.
The assays are for diagnosing hepatitis B infection in individuals with acute or chronic hepatitis B, or who are recovering from hepatitis B infection.
Medcis Pathlabs and its associates and attendees will buy Co-Diagnostics' tests for hepatitis B, hepatitis C, HIV, and human papillomavirus.
Johns Hopkins researchers have developed a proof-of-concept test for research use that they hope to eventually refine for clinical use at the point of care.
The firm, which raised $7.1 million from its IPO last week, is looking to move into geographies where a need for infectious disease tests are already well established, its CEO said.
The firm launched the service in part because it recognized that consumers increasingly prefer to pay for their healthcare services out of pocket and without having to get physician referrals.
Hologic CEO Steve MacMillan said that the deal is so compelling that the firm needed to do it now.
The test enables donor screening laboratories to use PCR-based diagnostic technology to screen donated blood and plasma.
Professional, molecular, and tissue diagnostics sales continued to grow during the first three quarters, while diabetes care sales remained in decline.