Verax Biomedical Inc, of Worcester, Massachusetts, was awarded approval by the FDA to market its PGD blood test system.
The FDA said the test is intended to supplement tests used by blood establishments following collection of platelets. Blood centers sample cultures of donated platelets 24 hours after donation, read the tests in the next 24 hours and then discard any contaminated units. However, the FDA said there is a possibility that the number of bacteria present at the time of culture may be so low that bacteria can’t be detected, so the rapid test would be able to pick up bacterial contamination closer to the time the blood might be used.
More from the Wall Street Journal…
Watch a short animation on the use of the device…
Platelet PGD product page…