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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."

The latest iteration of a bill being drafted by Republican Senator Orrin Hatch includes new proposals to bring "follow-on" diagnostics to market and a process for grandfathering in already-commercialized IVD products. Other issues, such as the development of a market-based pricing model for advanced personalized diagnostics, are still under consideration.

"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.

Given that RUO/IUO products are being marketed and used by life science players in numerous ways, the FDA's proposed restrictions will not be an easy task for industry to implement or for the agency to enforce.

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.

FDA believes Pathway Genomics is offering a device that has not been cleared for marketing by the agency, and that the firm has "moved outside of the currently sanctioned boundaries for lab-developed tests by marketing a product in a retail store that asks consumers to collect the sample."

During a webinar hosted this week by Genetic Alliance, Paul Radensky, a partner in the law firm McDermott Will & Emery, discussed FDA's regulation of diagnostic tests and noted that ACLA met with FDA Commissioner Margaret Hamburg to discuss a proposal for an inter-agency approach to regulating LDTs.

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AstraZeneca has released its coronavirus vaccine trial protocol, according to the New York Times.

According to the Guardian, more than 150 countries have signed on to a global SARS-CoV-2 vaccine plan.

Time magazine looks into how liquid biopsies are changing cancer care.

In PNAS this week: similar muscle protein patterns across hypertrophic cardiomyopathy phenotypes, analysis of gene expression and brain anatomy in major depression, and more.