The U.S. health regulators plan to downclassify certain tuberculosis (TB) tests, a move that should boost the development of TB diagnostics.
The U.S. Food and Drug Administration (FDA) propose to lower the current risk classification for nucleic acid-based tests to Class II (moderate-risk) from Class III (high-risk), which the agency says requires the more rigorous pre-market approval application.
According to the agency, nucleic acid-based tests detect the genetic material of infecting bacteria, helping in timely detection of TB disease. When used along with other clinical tests, these tests can result in improved patient results and stop further spread of TB.
TB is caused by a bacterium called Mycobacterium tuberculosis. The bacteria usually attack the lungs, but TB bacteria can attack any part of the body such as the kidney, spine, and brain. TB is spread through the air from one person to another. If not treated properly, TB disease can be fatal.
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According to the Centers for Disease Control and Prevention (CDC), one third of the world's population are infected with TB. Around nine million people around the world became sick with TB. Common symptoms of TB disease include: a bad cough that lasts three weeks or more, pain in the chest, coughing up blood or sputum, weakness or fatigue, and weight loss.
The CDC recommends health care providers perform nucleic acid testing on at least one sample of mucus coughed up from the lower airways (sputum) from patients with signs and symptoms of TB disease, when the test result would alter patient treatment. The FDA's new proposal will support CDC recommendations.
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General controls alone are not sufficient to assure safety and effectiveness of Class II and Class III tests. Class II devices are also subject to special labeling, mandatory performance standards, and post-market surveillance, according to the FDA.
The FDA believes it can still address the safety and effectiveness of the nucleic acid-based diagnostics for TB through its draft guidance, which identifies the risks related to false positive and false negative test results as well as recommends on how to mitigate those risks.