“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 objectives.” OR “The Centers for Medicare & Medicaid Services (CMS) regulates labs but has limited insight into the quality, reliability, or usefulness of LDTs, including whether patients have been harmed as a result of their use.”
Recent Posts
- United States Obtains More Than $370 Million In Judgments Against Kentucky Businessman And His Companies For Laboratory Testing Scheme That Targeted Medicare
- Raising the Bar on Biomarker Test Accuracy Should Be Part of Access Efforts
- Lab Owner Sentenced for $463 Million Genetic Testing Scheme
- Experts Call for Better FDA Policing of Direct-to-Consumer Polygenic Risk Scores
- Genomic Data Heterogeneity across Molecular Diagnostic Laboratory – Published in The Journal of Molecular Diagnostics
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