A deep analysis of data from drug tests performed at Quest over the past six years has helped the company identify which drug tests are needed by clinicians.
Abbott CEO Miles White is bullish on the firm's Alinity systems, while Quest and LabCorp see acquisitions as the likely result of further PAMA-related cuts.
The solutions being developed will leverage AI from labs globally and will accelerate the number of new test algorithms available to the lab diagnostics market.
In a letter to CMS, AMP made a case for crosswalking existing CPT codes for BRCA1/2 testing to codes that more accurately reflect the work required to analyze these genes.
Genfit's assay will be deployed through Covance's central laboratories to validate its use to better identify and characterize patients with the liver disease.
CMS says fee hike would bring in $62.1 million, an amount necessary to maintain critical regulatory functions of the CLIA program into fiscal year 2022.
Smaller labs that serve large Medicare populations, such as skilled nursing facility labs, have cut services and expressed concerns about their survival.
Both Opko and Phillip Frost will pay penalties and refrain from certain activities. Frost had been accused by the SEC of participating in market manipulation schemes.
The amicus briefs challenge the method in which HHS collected data to establish market-based Medicare prices and found flaws in a district court decision dismissing the case.
The draft guidance has been reissued with updates based on industry comments and is intended to lay out the steps necessary to get simultaneous 510(k) and CLIA waiver approval.
