Jun 30, 2022 | News
“The current diagnostic testing regulatory system—in which tests are regulated according to where they are developed and used, rather than the risk they pose if they are inaccurate—creates double standards and potential loopholes that undermine public health...
Jun 30, 2022 | News
“Given a changing landscape in terms of the volume, technology, and business model of IVDs offered as LDTs since 1976, in combination with the increasingly important role of diagnostic devices, including LDTs, in critical clinical treatment decisions, the FDA does not...
Jun 30, 2022 | News
“One in 10 Americans who have received a test result report inaccuracy” https://www.pewtrusts.org/en/research-and-analysis/fact-sheets/2022/05/americans-support-increased-fda-oversight-to-ensure-accuracy-of-diagnostic-tests The post Americans Support Increased FDA...
Jun 30, 2022 | News
“A problem for the industry is that…[the same] variant is classified as a ‘variant of unknown significance’, ‘likely benign’, and ‘pathogenic’ by different laboratories due to variations in interpretation.”...
Jun 30, 2022 | News
“The data show that 7 (37%) of 19 laboratories correctly reported all variants for both wet and dry samples; [the FDA-approved test] also correctly reported all variants for both wet and dry samples” “Variable accuracy in detection of genetic variants among some...
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