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.
Customers might want to consider what they might learn about their risk of diseases like Alzheimer's before snagging the genetic testing kits that are on many gift guides this year, NJ.com writes.
The Wall Street Journal reports there is uncertainty surrounding whether He Jiankui's embryo editing did what he said it did.
Stat News reports that the pause on procuring fetal tissue for intramural US National Institutes of Health research will soon affect additional labs there.
In Nature this week: genomic analysis of the invasive fall webworm, amp of constrained coding regions within the human genome, and more.