FDA Watch: Agency Takes Steps to Downgrade Some Nucleic Acid-Based Tests to Class II
The change is expected to dramatically cut the costs of developing new tests
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Articles and Reports
Genetic Testing Kickback Scheme Results in 46-Month Prison Term
Federal prosecutors continue to target situations where third-party recruiters influence test ordering
Dx Deals: Labs Exploring Cryptocurrency Share Their Plans
Know Labs and ProPhase Laboratories discussed plans that in part involve digital currencies
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
A Primer on Who Regulates Hazardous Waste in the Lab
We explain the fundamentals of hazardous waste generation, classification, and management
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
