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fda ldt
FDA Will Have No Authority Over Laboratory-Developed Tests, HHS Says
By Robert Michel | From the Volume XXVII, No. 12 – August 24, 2020 Issue
This is an excerpt of a 2,029-word article in the August 24, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implic…
HHS ‘Stands Down’ FDA on Its Oversight of LDTs
By Robert Michel | From the Volume XXVII, No. 12 – August 24, 2020 Issue
CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implications for the federal Food and Drug Administration’s efforts to assert regulatory oversight of laboratory-developed tests (LDTs). In a statement last week, HHS said t…
Concerns Raised Over Pharmacogenetic Tests
By Joseph Burns | From the Volume XXVI No. 12 – September 3, 2019 Issue
CEO SUMMARY: Some executives at pharmacogenetic testing companies are criticizing the federal Food and Drug Administration for its recent actions to exercise oversight over PGx testing. But there is more to the story, said one expert who is a past adviser to the FDA on clinical laboratory…
Proposed Bill in Congress Would Regulate LDTs
By Joseph Burns | From the Volume XXIV No. 7 – May 15, 2017 Issue
CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both …
LabCorp Now Larger than Quest, Two Labs Report 2015 Earnings
By Robert Michel | From the Volume XXIII No. 3 – February 29, 2016 Issue
IN RECENT WEEKS, the nation’s two largest lab companies reported fourth quarter and full-year earnings for 2015. The earnings reports reveal how the paths of the two companies are diverging. The companies are diverging because of a major acquisition made in February 2015, by Laboratory Cor…
Official Makes Case in Favor of FDA LDT Guidance
By Mary Van Doren | From the Volume XXII, Number 18 – December 28, 2015 Issue
IN THIS EXCLUSIVE NEWS COVERAGE of a public appearance by a key FDA official, THE DARK REPORT provides lab executives and pathologists with a more nuanced understanding about the thinking behind the proposed …
CURRENT ISSUE

Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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