The firm said that the test provides results of HBV status in 15 minutes with high analytical sensitivity, and that testing can be completed while the patient is present.
The test measures hepatitis B viral DNA and is intended to be used to assess prognosis and response to antiviral therapies.
The assay is designed to quantitate HBV DNA in serum or plasma to assist in the treatment of chronic HBV-infected patients receiving antiviral therapy.
Researchers have established that two simple tests can determine whether a person meets guidelines to receive antiviral treatment.
The firm noted that the premarket approval means that the three major viral load assays that most laboratories run for patients are now available on a single system.
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.
The test adds to the firm's current portfolio of 30 infectious disease and oncology tests that use its Sentosa PCR and NGS workflow.
One of the applications seeks premarket approval to run the Vitros immunodiagnostic HIV combo assay on the Vitros 3600 system.
The test could be useful to up to 2.2 million patients with chronic HBV to determine whether treatment is working and whether it can be stopped.