The company hopes to commercialize the assay, and is pursuing a larger validation study, but may face competitors who have also staked claims for this indication.
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.
Independent research teams identified and sequenced hepatitis B strains going back thousands of years from samples in Europe, uncovering now-extinct lineages.
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.
While the virus they found appears old, the researchers found it to be closely related to modern ones, indicating that it has infected people for centuries.
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.
Following a beta evaluation of the system, a virology lab in Sheffield, UK, ran a workflow assessment and found improvements with the system.
The tests are the first assays approved by the FDA to run on the firm's Cobas 6800 and Cobas 8800 systems.
Researchers representing scientists and students of Chinese descent voice their concerns about recent US policies and rhetoric.
Wired reports that researchers have shown they could reprogram a DNA-based computer.
Researchers say increased diversity in genomic studies will benefit all, PBS NewsHour reports.
In Science this week: whole-genome sequencing of single sperm cells, and more.