TAG:
IVD
Global IVD Companies Report First Quarter 2024 Earnings
IN THEIR INITIAL FINANCIAL REPORTING F…
ACLA President Van Meter Discusses LDT Lawsuit
CEO SUMMARY: On July 5, the final laboratory developed test (LDT) rule issued by the federal Food and Drug Administration (FDA) takes effect. In response, the American Clinical Laboratory Association (ACLA) filed a lawsuit in federal court in Texas to challenge the FDA’s actions. In thi…
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) …
CURRENT ISSUE
Volume XXXII, No. 7 – May 12, 2025
Economic, Tech changes drive lab concerns, The Dark Report provides insights from the Executive War College speakers about how clinical labs can use business strategies and tactics to handle the new tariffs, future regulations, and artificial intelligence (AI). Also, this issue provides guidance on how labs and pathologists should prepare for payer audits.
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