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.
The DxN Veris was recently launched as a CE-marked product with a menu of viral load tests, and will launch in a few years in the US with STD and HAI assays.
The new company will be focused entirely on hepatitis B, although officials previously said that Tekmira's other non-HBV RNAi programs would continue to advance.
The new assay expands a portfolio of viral load monitoring tests for the Cobas 6800 and 8800 systems.
The Associated Press reports that the US government wasted $341,000 on travel by former Health and Human Services Secretary Tom Price.
Women who post YouTube science videos get more critical comments and more comments about their appearance than male video hosts, the New York Times reports.
The Wall Street Journal writes that participating in genetic research brings up the specter of past research ethics lapses for some African Americans.
In PLOS this week: sequences influencing yeast prion aggregation or degradation, dengue virus genetic variants affect transmission dynamics, and more.