Innovations in Lab Testing Arriving at Light Speed

By R. Lewis Dark | From the Volume XXXII, No. 4 – March 10, 2025 Issue

TODAY, IT’S A CHALLENGE TO STAY UP WITH ALL THE NEW THINGS arriving in the lab testing marketplace. Novel assays are launched weekly. That is equally true for next-generation automation and lab analyzers, with vendors regularly announcing something new to their menu of products. The pace of innova…

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Medical Robotics Developer Says It’s Time to Transform Phlebotomy

By Robert Michel | From the Volume XXXII, No. 4 – March 10, 2025 Issue

“Our innovation aims to make blood draws fully autonomous, safer, faster, more accurate, less painful, and more accessible.” —Brian Joseph, co-founder, Vitestro CEO SUMMARY: Phlebotomy and collection of veinous blood is one important procedure in clinical…

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Upcoming Executive War College to Cover Important Lab Trends

By Robert Michel | From the Volume XXXII, No. 4 – March 10, 2025 Issue

New developments now changing the landscape in health-care and the clinical laboratory market will be addressed at the upcoming 30th Annual Executive War College on Diagnostic, Clinical Laboratory, and Pathology Management that happens on April 29-30, 20…

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Why Labs Should Comply with FDA’s Final Rule on LDTs

By Robert Michel | From the Volume XXXII, No. 3 – February 17, 2025 Issue

CEO SUMMARY: Even as lawsuits challenging the Laboratory Developed Test (LDT rule) issued by the federal Food and Drug Administration (FDA) progress in federal court, clinical labs performing LDTs face an interesting decision. Should they invest the staff time and money to comply with the…

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OIG Issues New Report on Medicare 2023 Lab Spend

By Robert Michel | From the Volume XXXII, No. 2 – January 27, 2025 Issue

CEO SUMMARY: When the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) issued its latest report on Medicare spending in 2023 for clinical laboratory tests, it attracted relatively little attention from the lab industry. Maybe other issues—such a…

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Pathologist Asks ChatGPT, Google Notebook to Predict LDT Trial Outcome

By Robert Michel | From the Volume XXXII, No. 1 – January 6, 2025 Issue

On his blog last month, pathologist Bruce Quinn, MD, PhD, published the answers provided by two artificial intelligence chatbots after he asked each to analyze the legal briefs submitted to federal courts in Texas where lab plaintiffs are challenging the FDA’s laboratory developed test (LDT) final …

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Using AI to Predict Outcomes in FDA LDT Lawsuits

By R. Lewis Dark | From the Volume XXXII, No. 1 – January 6, 2025 Issue

Given the popular sentiment that artificial intelligence (A…

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Top 10 Lab Stories for 2024 Reflect Important Trends

By Robert Michel | From the Volume XXXI, No. 17 – December 16, 2024 Issue

CEO SUMMARY: Most clinical laboratory managers will agree that the Food and Drug Administration’s (FDA) final rule to regulate laboratory developed tests (LDTs) is the biggest lab industry story for 2024. Every laboratory performing LDTs must now devote money and time to comply with the…

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November 25, 2024, Intelligence: Late-Breaking Lab News

By Robert Michel | From the Volume XXXI, No. 16 – November 25, 2024 Issue

Disruption is happening in the consumer genetic testing marketplace. In recent weeks, news outlets in the United Kingdom reported that Atlas Biomed, a consumer genetic testing company founded in 2016, had simply “disappeared.” Malwarebytes said Atlas Biomed’s “London offices …

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129,624 Genetic Tests in the United States

By R. Lewis Dark | From the Volume XXXI, No. 16 – November 25, 2024 Issue

REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) by the federal Food and Drug Administratio…

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