Toward a New Paradigm in Regulating Diagnostics: Liz Mansfield, FDA


Liz Mansfield, Director of Personalized Medicine, OIVD, FDA

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Listen (5:04) New report on personalized medicine

Listen (1:54) How is the FDA handling CoDx associated with breakthrough therapies?

Listen (1:52) Is the FDA open to seeing the use of POC tests as CoDx?

Listen (5:11) How much authority do you actually have?

Listen (3:10) Regulating whole genome tests

Listen (2:00) Are we headed to a world of CoRx?

Listen (5:35) Moving toward a new paradigm of diagnostics regulation

We're happy to have Liz Mansfield from the FDA to the program as part of our series on CoDx. Liz is Director of Personalized Medicine in the Office of In Vitro Diagnostics.

The symbiotic relationship between business and regulation has been part of our American history from the days of the railroads to the present age of genomic medicine. New technology is constantly presenting difficult questions to the public, opportunities for business, and challenges for regulators. For example, there are a slew of new point-of-care tests coming on the market. How open is the FDA to seeing these tests used as CoDx? And how is the regulatory body preparing to evaluate a test on 3 billion base pairs, a whole human genome. Some wonder if the FDA will lose its relevance in the genomic age when there are vast amounts of data floating around and a whole genome test is easily available.

In today's interview, Mansfield chips away at these questions with confidence and a certain amount of humility in the face of the coming technologies. Unable to say whether any company has yet sought approval on a whole genome test, she does say that the team at FDA is preparing for such time.

"We've seen this coming," she says. "Huge amounts of data can be drawn out of a single sample. And we've had to come up with a new paradigm for regulation where we're not to look at each individual measurement so closely. We're going to have to ask for representative measurements and trust those more than we have in the past."

Podcast brought to you by: Myraqa Clinical Research: The CRO for Point of Care and PMA Diagnostics.

Editor's Note: Our apologies for the static in the interview. Liz was on an internet phone at her office and there is slight interference. Also, since this show was published, the FDA cleared a Dx Assay on Illumina's MiSeq platform (Nov 20, 2013).