2026 Predictions for Clinical Labs: AI, Audits, and Increased Enforcement
How clinical laboratories should prepare for the next wave of oversight in the new year
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Articles and Reports
Dx Deals: Sonic Healthcare Buys East Coast Lab in First Such US Acquisition Since 2021
Australian firm has grown its overseas operations dramatically in the past decade, except in America
Chevron Doctrine’s Dismissal Has Yet to Upend Regulatory Environment
However, clinical laboratories may have more say in future laws and guidance thanks to 2024 decision
FDA Watch: Mass Spectrometry Test Receives First Moderate Complexity Designation
Roche’s vitamin D assay includes internal quality controls that allowed it to obtain the CLIA designation
Dx Deals: Corewell Health Enters Joint Venture with Quest Diagnostics
The lab giant and the Michigan health system will build a 100,000-square-foot lab as part of a new business
FDA Watch: BD Receives FDA Approval for Veritor, a Pandemic Staple
The assay was widely used during the early months of COVID-19 and was a significant source of revenue growth for a time
PAMA Cuts Loom and New Lab Reporting Deadline Nears, Both on January 1
However, a proposed bill called the RESULTS Act is racing to thwart the cuts to lab test reimbursement rates
Is Prior Authorization Reform on the Horizon?
Government reform and payer streamlining may reduce the burden on healthcare providers, but laboratories should remain vigilant
The Success of AI in Lab Billing and Coding Hinges on Good Data
Two revenue cycle management experts explain opportunities that clinical laboratories have with artificial intelligence
Dx Deals: Illumina to Acquire SomaLogic from Standard BioTools for $425M
The deal is expected to be a big boost for Illumina’s next-generation sequencing platforms
FDA Watch: Agency Launches Database of Complete Response Letters Sent to Drug Manufacturers About Initial Rejections
The early focus is on drug applications, but it could spread to the laboratory test approval process as well
CMS Clarifies CLIA Personnel Requirements in Rare Memo
Clinical labs gain flexibility in meeting regulatory standards while potentially reducing their costs
Expert Q&A: AMR Warnings Need to Be Louder, and It Just Can’t Be Up to Labs
John Osiecki of bioMérieux also discusses AI for outbreaks and regulation trends
