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Mayo Clinic
Mayo Clinic’s Ambitious Digital Pathology Initiative
CEO SUMMARY: It’s the latest example of an academic medical center moving to develop its own digital pathology solutions. This collaboration involves Mayo Clinic, Nvidia, and Aignostics. The three will work together to use digital pathology images and patient data from Mayo Clinic and C…
Owens & Minor Sues Anthem BCBS of Virginia
CEO SUMMARY: For years, clinical laboratories and pathology groups have expressed frustration with the lack of transparency by health plans in how they handle claims, set prices, and establish coverage guidelines. Now, because of recent federal laws and rules concerning health data transp…
October 14, 2024, Intelligence: Late-Breaking Lab News
Babson Diagnostics of Austin, Texas, received a “strategic investment†from Becton, Dickinson and Company (BD). The amount of the investment was not disclosed. In the past year, Babson launched an innovative lab testing service with retail pharmacies in Austin an…
Hospital Lab Outreach: Still a Valuable Asset!
CEO SUMMARY: Hospital lab administrators everywhere are watching press releases announcing the latest agreement of a major health system selling its laboratory outreach business to one of the billion-dollar lab corporations. The pace of these sales is accelerating. These deals confirm the…
Clarapath Raises $36 Million for Automated Histology Solution
AS THE HISTOLOGY WORKFORCE STRUGGLES TO KEEP UP WITH RISING CASE DEMAND, Clarapath—a Hawt…
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…
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…
Lab News Briefs
New York Times Reviews DNA Testing Kits for Its Readers It’s a sign of the times when The New York Times considers it useful to conduct and publish a review of DNA ancestry testing kits to guide readers. AncestryDNA of Lehi, Utah, was picked as “the most eff…
Digital Pathology Business Plan for Both Clinical and ROI Success
CEO SUMMARY: More pathology groups are ready to consider adopting whole-slide imaging and digital pathology. The decision to proceed should only be made after identifying the clinica…
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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