laboratory-developed test Archives

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laboratory-developed test

Enjoy the LDT Court Victory, Yet Remain Vigilant

By R. Lewis Dark | From the Volume XXXII, No. 6 – April 21, 2025 Issue

VICTORY IN COURT! FOR AN INDU…

With LDT Rule Vacated, Labs Await FDA Retort

By Robert Michel | From the Volume XXXII, No. 6 – April 21, 2025 Issue

CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form…

In the Past, Labs Used Courts to Thwart Feds

By Robert Michel | From the Volume XXXII, No. 6 – April 21, 2025 Issue

CEO SUMMARY: A federal judge’s recent decision to vacate the FDA’s final rule on laboratory developed tests harkens back to a 2008 case where clinical labs stopped a CMS competitive bidding project. In the earlier case, legal risks led the government to back down. The …

White House Is Off to a Fast Start, So Pay Attention

By R. Lewis Dark | From the Volume XXXII, No. 5 – March 31, 2025 Issue

We already see the second term of President Donald Trump…

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…

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…

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…

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 …

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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