As laboratory-developed tests play a larger role in U.S. health care, it’s more important than ever to ensure that they are safe and accurate.
Good doctors are a bit like good detectives. They use their wits, informed by training and experience, to track down the precise cause or causes of a patient’s symptoms and recommend the best treatment. And the clues that physicians follow often come from laboratory tests — of blood or tissue samples, for example. Get the tests right and you can make a diagnosis. If the test results are wrong, though, little else can go right.
would be phased in over about four years, to avoid unduly interrupting the use of existing laboratory tests, or tests intended for small patient populations. It is hardly burdensome; lab-test developers already have a professional responsibility to make sure that their own tests work; it should be easy enough to provide that evidence to the FDA.as medical devices. The agency began to regulate manufactured test kits, but it chose to exempt labs that created their own tests for their small patient populations. In those pre-software days, tests were simpler and lower-risk. Since then, though, they have proliferated and become more complex.
During a Monday hearing, Judge Tanya S. Chutkan rejected as “far beyond what is necessary” Donald Trump’s demand to postpone until mid-2026 his trial for allegedly obstructing the results of the 2020 election. Instead,— the day before Super Tuesday. Six months is more than enough time for defense counsel to prepare. GOP primary voters deserve to know the outcome when choosing their standard-bearer.
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