Jul 31, 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...
Jul 31, 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...
Jul 31, 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.”...
Jul 31, 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...
Jul 31, 2022 | News
Center For Genomic Interpretation (CGI) is very excited to share the interview edition of our monthly newsletter. Justin Zook, Ph.D. is the Co-Leader of Biomarker and Genomic Sciences Group at the National Institute of Standards and Technology (NIST). In the...
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