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.
The combined debt and equity financing for the Washington state allergy lab comes as demand for food-related allergy testing is growing.
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.
Clinicians need to understand higher-sensitivity troponin assays will detect longer-term cardiac injury as well as acute conditions, experts say.
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.
A lack of attractive targets, high valuations, and a more attractive IPO market contributed to a 45 percent year-over-year decline in M&A.
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.
Molecular Testing Labs allegedly made payments to labs in exchange for Medicare and Tricare referrals between August 2014 and July 2015.
The lab analytics service provides insurers with guidance aimed at helping them achieve improvements in quality performance metrics.
The proposed $540 million acquisition gives Sydney-based Sonic Healthcare greater scale and a larger geographic presence in the US laboratory market.
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.
Pathology groups throughout the health system are being grouped hub and spoke into networks to better manage staffing needs and control costs.
HHS Secretary Azar's implementation of PAMA resulted in market-based Medicare prices that don't accurately represent the market, ACLA argues.
ACLA was critical of the report, saying it "fails to reflect market reality" and calling on Congress to intervene to prevent further cuts.
The company attributed the lower revenue growth to lower volume growth in diagnostics, which is expected to continue for the rest of the year.
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.