FDA proposes rule to spur development of TB tests
The FDA's new ruling would lower the risk classification for nucleic acid-based tests, allowing manufacturers to utilize a more streamlined clearance pathway needed for medical devices, according to RTTNews.com.
Nucleic acid-based tests are capable of detecting the presence of copies of TB's genetic material - either RNA or DNA - in a patient's sputum. The FDA said that the testing allows for a more timely diagnosis of TB. Currently, the FDA has rated the tests Class III, or high risk.
Class III devices require a more rigorous pre-market approval application than lesser classes. In proposing to reclassify nucleic acid-based tests as Class II, moderate risk, the FDA has also released a draft guidance intended to aid manufacturers.
The guidance identifies the risk of false negative and positive test results and the risks posed to healthcare workers that must handle the specimens. It also makes a series of recommendations on how to mitigate those risks, RTTNews.com reports.
The FDA said that the nucleic acid-based tests can shorten diagnostic times from one to two weeks to one to two hours. When used properly and in conjunction with other tests, the FDA said that the tests can result in earlier treatment and possibly interrupt the spread of the disease.