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FDA

Read the Tea Leaves… FDA Will Require LDT Review

PROPOSED FEDERAL REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) IS CURRENTLY THE HOT-BUTT…

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Who’s For and Against FDA Draft LDT Rule?

CEO SUMMARY: One analysis determined that 43.2% of the public comments were in support of the proposed LDT rule and 55.2% were in opposition to the rule. More telling, however, is that of the 2,900 comments in support, only 56 were not form letters! In contrast, about 1,300 individual com…

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FDA & CMS Issue Letter, Agree on LDT Oversight

CEO SUMMARY: With the release of a public statement about the oversight of LDTs on Jan. 24, 2024, officials at both the Food and Drug Adminstration and the Centers for Medicare and Medicaid Service went on record that both agencies are aligned in the spec…

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FDA Has a Ticking Time Bomb with LDT Rule

PROPOSED REGULATION OF LABORATORY DEVELOPED TESTS (LDTs)…

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OIG Reports Its Findings about CDC’s First COVID Test Problems

ONE MAJOR FAILURE BY FEDERAL AGENCIES in the first days of the COVID-19 pandemic was the development and release of an inaccurate and unreliable SARS-CoV-2 test, intended for use by public health labs. This was the finding of the U.S. Department of Health and Human Services (HHS) …

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2024: Year of Decision for FDA Regulation of LDTs

FOR OFFICIALS AT THE FEDERAL FOOD AND DRUG ADMINISTRATION…

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Year’s Top 10 Lab Stories Contain Surprises & Twists

CEO SUMMARY: With the SARS-CoV-2 pandemic now in the rearview mirror of the nation’s clinical labs and pathology groups, the important news stories of 2023 were mostly about developments where the consequences will influence laboratory operations in coming years. Artificial intelligence…

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Violating EKRA Earns Lab Owner an Eight-Year Prison Sentence

THIS MAY BE THE MOST HIGH-PROFILE CASE involving a clinical laboratory and the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Former Arrayit Corporation president Mark Schena was sentenced in October 2023 to eight years in federal prison and ordered to pay $24 million in resti…

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Payers Are Right to Be Wary of Claims for Some LDTs’ Value

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November 13, 2023, Intelligence: Late-Breaking Lab News

Federal regulators recently confirmed that Dec. 4 remains the deadline for public comment on the proposed rule that the federal Food and Drug Administration (FDA) would use to regulate laboratory developed tests (LDTs). This was confirmed during a public webinar for the lab and in vi…

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