The settlement resolves claims that Advanced Pathology Solutions provided illegal incentives to gastroenterology practices and performed unnecessary medical testing.
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Despite increasing demands, many laboratories continue to rely on outdated laboratory information systems that were built for a different era of healthcare.
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A new federal bill, the Enhancing CLIA Act of 2026, seeks to update oversight of laboratory-developed tests following a 2025 court decision, proposing a two-year delay for new requirements and a voluntary pathway for existing device clearances.
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The update integrates artificial intelligence into the system architecture to assist with case review, biomarker discovery, and laboratory operations.
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With the first FDA-cleared test and clinical guidelines debuting since May 2025, labs are evaluating how blood-based biomarkers fit into diagnostic protocols.
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