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.
The guidance recommends microsatellite instability testing or immunohistochemistry be used to detect abnormalities that may lead to Lynch syndrome.
The IGRA testing market is ballooning as industrialized nations try to curb the spread of tuberculosis, but the assays still fall short in certain settings and patient populations.
The essential diagnostics list — which may be available by early 2019 — has the potential to play an important role in guiding healthcare policies.
The law contains provisions that proponents say will advance precision medicine and speed new tests to market, but critics worry if this will come at a cost to public health.
The US Preventive Services Task Force said that the potential harms resulting from screening for HSV outweigh the potential benefits.
After passing the House of Representatives last week, the legislation is now set to go before President Barack Obama, who said he will sign it into law.
With strong bipartisan support, the White House indicated that President Barack Obama will sign the legislation once it receives Senate approval.
NIH has been conservative on the PMI's budget and its funds are sufficient to launch enrollment next year, begin collecting data, and initiate genetic testing pilot projects.
The US House of Representatives is expected to vote on the sweeping biomedical funding legislation this Wednesday.
Personalized medicine proponents are uncertain where funding, personnel, and priorities will land in a new administration and Congress.
According to multiple sources in Washington, DC, the FDA has been informing stakeholders in policy circles of the decision.