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LabCorp

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 …

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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…

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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 …

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Labcorp, Quest Issue Q1 Earnings, Offer Comments on FDA’s LDT Rule

  BOTH LABCORP, BURLINGTON, N.C., AND QUEST DIAGNOSTICS, SECAUCU…

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Labcorp to Acquire Only Certain Lab Assets of OPKO’s BioReference

Following Labcorp’s announcement that it will acquire “select assets” of BioR…

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April 29, 2024, Intelligence: Late-Breaking Lab News

It may be that the genetic data cat is out of the bag already. Nonetheless, lawmakers in Delaware are considering a bill that—among other things—would prevent life insurance companies from buying or using genetic testing data if it was obtained from ancestry companies and not from medical records…

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FDA Issues Memo to Reclassify Many High Risk IVD Assays

WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…

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Walgreens to Close 60 VillageMD Locations

CEO SUMMARY: Following substantial losses in fiscal 2023, Walgreens is working to cut costs and reduce overhead. One casualty in this effort will be the closure of 60 of the 360 primary care clinics in retail pharmacy stores built by Walgreens in recent years. These actions demonstrate th…

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Pathologist Paul A. Brown, MD, MetPath Founder, Dies at 85

EARLIER THIS YEAR, THE PATHOLOGY PROFESSION LOST one of what some call “the two Lions of Pathology.” On January 24, 2024, Paul A. Brown, MD, aged 85, died at his home in Palm Beach, Florida. In 1967, Brown was the founder of Metropolitan Pathology Laboratory, Inc., based in Ne…

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Labcorp, Quest Diagnostics Discuss Q4 & 2023 Earnings

DURING RECENT EARNINGS CALLS WITH FINANCIAL ANALYSTS AND INVESTORS, both Labcorp and Quest Diagnostics discussed their fourth quarter (Q4) and full year 2023 financial results. Each reported some stability in the market for clinical laboratory testing services, reflected in the numbe…

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