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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.

Originally published Oct. 1.
A new bill strongly supported within the diagnostics industry could put pressure on the Centers for Medicare & Medicaid Services to alter its procedures for setting reimbursement rates for molecular diagnostics.

NEW YORK (GenomeWeb News) – US President Barack Obama yesterday signed a bill into law that will expand the amount of user fees that the Food and Drug Administration collects from industry in the coming years, enact measures to shore up the agency's review resources, and streamline and speed up s

Since genetic tests were not discussed at a public meeting held this week on payment for new codes under the clinical lab fee schedule, "they cannot be priced under the laboratory fee schedule for 2012," a CMS spokesperson said.

Agency officials said during a recent MDUFA meeting that there will be "three guidance documents coming out together that will detail the proposed road forward in oversight of laboratory-developed tests."

FDA Commissioner Margaret Hamburg has hired Steven Spielberg, director of the Center for Personalized Medicine and Therapeutic Innovation at Children’s Mercy Hospital in Kansas City, for the newly created position of deputy commissioner for medical products and tobacco.

"CMS is the decision-maker here regarding fee schedule placement [of genetic tests] and we are pleased they are recognizing the importance … of having stakeholders provide input on the questions they've asked," said David Mongillo, vice president for policy and medical affairs at the American Clinical Laboratory Association.

The two-day meeting held by the agency in Hyattsville, Md., drew comments from numerous LDT developers and in vitro diagnostic companies, each side presenting their views on the current bifurcated regulatory pathway and FDA's stated intent to regulate all LDTs.

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Donal Quinn, Duncan Whitney

The device manufacturers' trade association, AdvaMed, has established a new group dedicated to the issues impacting in vitro diagnostics companies.

In Science this week: metagenomic-based technique for determining protein structure, and more.

An academic laments the rise of narcissism in the sciences, the Guardian reports.

Outgoing FDA commissioner Robert Califf writes in an editorial that the agency can help boost innovation.

The Trump transition team has asked NIH Director Francis Collins to remain at his post, though it's unclear for how long that will be.