FDA Approves TB Blood Test

Medical technology firm Cellestis on Dec. 3 announced that FDA had approved its tuberculosis blood test, called QuantiFERON-TB GOLD, a "breakthrough" method that is expected to replace the 100-year-old skin test currently in use, the Los Angeles Daily News reports. QuantiFERON detects immune responses to proteins associated with TB and therefore can detect infection even if symptoms have not developed, according to Cellestis spokesperson Marcy Pozzo. "The skin test doesn't detect nonsymptomatic cases. Ten to 15 million [people] harbor the latent infection -- most people will live and die and never know they have it, but up to 10% might develop TB if their immune systems are compromised," she said, adding, "You need a good testing method." Clinical data indicate that QuantiFERON has a 99% accuracy rate, according to the Daily News (Farrell Aidem, Los Angeles Daily News, 12/3). Cellestis CEO Tony Radford said that the company currently is working with several groups in the United States to introduce the new test. "There are numerous markets where our test will have a significant impact, including in prison and jails, public health TB programs and screenings for recent immigrants, health care workers and military personnel," he said (Dow Jones Newswires, 12/3).