TAG:
IVD
How Private Health Insurers May Respond to FDA LDT Regulation
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Significant Developments Are Shaping Lab Market
CEO SUMMARY: With 140 speakers and 1,000+ attendees, this year’s Executive War College again provided a comprehensive picture of the specific forces reshaping the U.S. market for lab testing services. Presented here is a smorgasbord of information and innovation shared by different spea…
FDA Hosts Webinar to Explain Key Issues with Final LDT Rule
ON APRIL 29. THE US FOOD AND DRUG ADMINISTRATION (FDA) announc…
FDA Issues Memo to Reclassify Many High Risk IVD Assays
WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…
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…
FDA Has a Ticking Time Bomb with LDT Rule
PROPOSED REGULATION OF LABORATORY DEVELOPED TESTS (LDTs)…
Lab News Briefs
Siemens to Explore Sale of Its IVD Diagnostics Unit Siemens Healthineers, Erlangen, Germany, is reportedly looking into options for sale of its in vitro diagnostics (IVD) segment. The company’s “review co…
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) …
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…
Most IVD Firms Increase Q3 2023 Base Business Revenue
Most in vitro diagnostics (IVD) companies reported increases in base business during the third quarter (Q3) 2023. The numbers, in the single digits, softened the blow from the continuing drop-off in COVID-19 test sales. Manufacturers of tests and laboratory instruments are launching ne…
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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