May 2025

Economic and Tech Changes Drive Lab Concerns

CEO SUMMARY: Uncertainty around tariffs, future regulations, and artificial intelligence (AI) defined the mood at the 2025 Executive War College, where nearly 1,000 lab leaders gathered. Speakers warned of how stagnant healthcare spending could trickle down to labs. Meanwhile, attendees considered potential tariff impacts on their lab supplies and how to navigate the threat of […]

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Don’t Pass Up Chance to Steer LDTs, PAMA Reform

Commentary and Opinion by R. Lewis Dark / Robert Michel

CLINICAL LABORATORY PROFESSIONALS HAVE RECEIVED A RARE CHANCE for their unified efforts to make a long-term difference in the regulation of the industry. Of course, that endeavor won’t come easy. As detailed in the pages of this issue, two high-priority concerns are awaiting a firm hand of guidance from conscientious labs: The future of laboratory

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Economic, Tech Changes Drive Lab Concerns

Clinical Laboratory Trends / Robert Michel

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As 23andMe Faces Bankruptcy, Home Testing Shows Warts

Clinical Laboratory Trends / Robert Michel

HIGH-STAKES DRAMA SURROUNDING 23ANDME’S BANKRUPTCY—including CEO Anne Wojcicki resigning to try to bid for the company she cofounded and state prosecutors urging caution about the data privacy of the company’s customers—brings up a fundamental question regarding direct- to-consumer (DTC) genetic testing: Is the consumer market strong enough to support long-term growth for DTC firms? Hints

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LDT Oversight May Fall to Congress, CLIA

Laboratory Compliance / Robert Michel

CEO SUMMARY: After a federal court struck down the FDA’s final rule on laboratory developed tests, attention has shifted to Congress and CLIA as likely paths forward for oversight. A lack of bipartisan momentum makes new legislation unlikely in the near term. Experts suggest CLIA reform is the more feasible option, taking advantage of existing

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Quest, Labcorp CEOs Discuss Tariff Strategies with Investors

Clinical Laboratory / Robert Michel

Leaders at Labcorp and Quest Diagnostics indicated that they are prepared to weather at least the early months of the unfolding tariff war that is upending the global economy. “There will be some impact from the tariffs, but our guidance range includes what we think are the most likely scenarios,” Labcorp CEO Adam Schechter said

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How Labs, Pathologists Should Prepare for Payer Audits

Laboratory Billing / Robert Michel

PAYER AUDITS ARE ON THE RISE, AND CLINICAL LABORATORIES AND PATHOLOGY PRACTICES THAT ARE NOT ADEQUATELY PREPARED could face millions of dollars in unexpected recoupment demands. That’s the word from Jane Pine Wood, JD, a healthcare attorney with McDonald Hopkins, LLC, who has found herself going to bat for labs that failed to respond to

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May 12, 2025, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

Yet another clinical laboratory has sold off part of its services to a national commercial lab. Labcorp announced on April 21 that it had finalized its acquisition of North Mississippi Health Services’ (NMHS) ambulatory outreach laboratory business. As part of the deal, Labcorp will become a referral laboratory for NMHS’ seven hospitals and clinic labs.

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