FDA Finalizes CLIA Waiver Guidance for Approval of New In Vitro Diagnostic Devices
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Test Quality: New Study Casts Doubt on Whole Exome Sequencing’s Accuracy in Diagnosing Genetic Disorders
Depending on the reporting laboratory, patients who undergo whole exome sequencing may receive false negatives or incomplete test results. That is the finding of a new study published in Clinical Chemistry
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FDA Watch: Agency Exempts Dozens of Tests from 510(k) Review
On Dec. 30, 2019, the U.S. Food and Drug Administration (FDA) published a final order exempting dozens of Class I and Class II medical devices that previously required 510(k) submission from 510(k) premarket review
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Standard Pathology Tests Outperform Molecular Subtyping in Bladder Cancer Tumor Classification
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ACMG the Latest to Come Out Against Genetic Testing for All Breast Cancer Patients
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