More articles about Policy & Legislation

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.

The legislation would establish an alternative approach for reviewing a subset of moderate-risk Class II devices.

The incidence of thyroid cancer has gone up 4.5 percent annually during the past decade without a corresponding change in the mortality rate, the USPSTF noted. 

The Ventana PD-L1 assay was approved as a complementary diagnostic for bladder cancer patients being considered for treatment with the immunotherapy Imfinzi. 

The bill would create tax credits covering half of the clinical testing expenses incurred in the development of rapid diagnostics for certain infectious diseases.

In a draft guideline, the USPSTF said that men between 55 and 69 should consult with their doctors about getting tested, a change from its 2012 recommendation. 

S.794 would require Medicare contractors to hold public meetings and disclose the rationale and evidence underlying an LCD at the start of the process.

The draft bill, based on a proposal developed by a coalition of Dx manufacturers and labs, would split oversight responsibilities across the FDA, CMS, and states. 

If approved, the new rules for IVDs would take effect in 2022. 

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