US civil surgeons screening immigrants for TB will need to perform an IGRA from Qiagen or Oxford Immunotec, instead of the decades-old tuberculin skin test.
The registry from the American Society for Clinical Pathology aims to eventually collect metrics on how lab services impact patient outcomes.
Lab industry groups hope to change CMS's controversial 2016 decision allowing nurses to perform complex lab tests.
The FDA's draft document noted that it is providing additional clarity to help itself and manufacturers better apply the concepts in a 2003 guidance document.
Lipid panel prices and prices for tests formerly bundled together as automated testing profiles are expected to rise in 2018, but fall in 2019.
Project would be managed by the US Centers for Disease Control and Prevention and would require tests from different manufacturers produce the same results.
ACLA urged the court to reconsider its ruling, arguing that it would be impossible for laboratories to comply with it.
OIG will evaluate data to assess whether PAMA pricing results in market-based rates
With only one test FDA-approved for primary hrHPV screening, groups express concern about feasibility of moving away from co-testing
Smaller labs, hospital outreach labs, and labs servicing high numbers of elderly are thought to face the highest risks.
The biggest losers following the release of the preliminary PAMA rates may be Quest and LabCorp, analysts said today.
Genetic counselors and patient advocates say more people are refusing genetic testing because they're uncertain of how it will impact their insurance.
Project Santa Fe, formed last year by five health system-based labs, aims to share strategies and lab-driven programs for improving patient care with labs in other health systems.
The PHG Foundation's report calls for raising clinician awareness about ctDNA testing technology in order to improve patient access to targeted therapies.
The group is proposing women ages 30 to 65 be screened with cervical cytology every three years or receive testing for high-risk HPV every five years.
A federal court dismissed the litigation saying that the patent at the center of the dispute applies routine and conventional techniques to a law of nature.
Among the tests that French national health insurance system will reimburse are IGRA tests, including ones from Qiagen and Oxford Immunotec, for screening TB.
GHTC, an advocacy group, said that member nations must contribute needed financial resources so that WHO can implement an effective diagnostics guide.
QuantiFeron-TB Gold Plus is an immunoassay that detects the release of interferon-gamma as a proxy for latent tuberculosis infection.
Entering a new chapter with a new leader, ACLA lends support to a draft bill that would regulate lab tests not as medical devices but as in vitro clinical tests.