FDA approves two new plasma-based tests, expands use of a third
- The FDA has approved a test that detects severe combined immunodeficiency disease (SCID) in newborns, as well as a test that predicts the risk of coronary heart disease. And in an unprecedented move, the FDA granted a waiver for the availability of a rapid screening for syphilis test in order to expand testing for the infection.
- Each year in the U.S., there are 40 to 100 new cases of SCID, which is fatal if untreated.
- Each year, 385,000 people die of CHD in the U.S., and racial minorities face a higher risk, compared with others.
If doctors are able to convince patients to get screened for these conditions, it could be a big deal in terms of preventing greater healthcare costs down the line.
The PLAC test predicts risk, thereby facilitating early intervention. With respect to syphilis, a sexually transmitted disease that increases risk of HIV, 55,000 new cases are diagnosed annually.