TAG:
FDA
Clarapath Automates Slide Prep, Microtomy Workflow
>>CEO SUMMARY: Histology is one area of laboÂratory medicine that utilizes a mostly manual work flow. However, pathology labs will soon have a novel solution designed to automate many of the steps in microtomy that produce glass slides. Reduced variability in the finished glass s…
Global IVD Companies Report First Quarter 2024 Earnings
IN THEIR INITIAL FINANCIAL REPORTING F…
LDT Rule Is Now a Fact! What Will Be Consequences?
TODAY, THE NEW RULE FOR REGULATION OF LABORATORY DEVELOPED TESTS …
ACLA Files Court Challenge to FDA’s Final LDT Rule
CEO SUMMARY: Discussing the FDA’s final LDT rule, one pathologist tracking this matter wrote, “In many ways, the FDA’s plan [final LDT rule] is like the guy who gets three wishes from a genie, and he asks for unlimited wishes.†ACLA and HealthTrackRx are challenging the FDA’s  
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…
Attorneys Assess Impact of FDA’s Final LDT Rule
CEO SUMMARY: Publication of the Food and Drug Administration’s final rule on laboratory developed tests (LDTs) is already causing some labs to consider withdrawing their existing LDTs because of compliance costs. Two experienced lab industry attorneys discuss aspects of the LDT rule and…
Several Times, Feds Tried to ‘Redirect’ Lab Activities
CEO SUMMARY: Regulation of laboratory developed tests (LDTs) by the Food and Drug Administration (FDA) may turn out to be one of the most impactful federal laws or regulations ever promulgated, so far as it pertains to clinical laboratories.cThe Dark Report provides this historical look b…
How Private Health Insurers May Respond to FDA LDT Regulation
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June 10, 2024, Intelligence: Late-Breaking Lab News
Once a high-flier lab test manufacturer with a market valuation of $2 billion, Cue Health of San Diego filed for Chapter 7 bankruptcy on May 28. Analysts now say the company is valued at about $15 million. Founded in 2010, Cue Health was developing a test system that consumers could …
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…
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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