On a conference call, the firm's CEO said that it and other industry players are pushing to postpone implementation of PAMA to no earlier than July 1, 2018.
A dozen senators fired off a letter to the agencies seeking questions to answers surrounding the recent recalls of lead-poisoning tests and systems from Magellan Diagnostics.
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 bill would create tax credits covering half of the clinical testing expenses incurred in the development of rapid diagnostics for certain infectious diseases.
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.
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.
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.
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.
