Rheumatology Tests and the New Precision Medicine Initiative

Mar 03, 2015

Rheumatology tests top the list of FDA-approved biomarker panels today. But the most prominent of these has fallen from favor, and rheumatology doesn't even rate a mention in the Precision Medicine Initiative.

Rheumatology tests top the list of approved biomarker panels today, according to a recent report. But the specialty seems almost invisible in the new government-sponsored focus on personalized medicine.

Of the 43 unique biomarker panels (those including more than three tests, as opposed to single-item biomarkers) approved by the FDA since 2003, almost half measure antinuclear antibodies (ANA), according to a new analysis. (Many of these are "me-too" tests using similar reagents.)

Ironically, ANA tests also top the list of procedures that rheumatologists are advised to avoid or at least rethink, in "Choosing Wisely" consensus documents from both American and Canadian rheumatology societies. Frequently positive in healthy people and not well-defined as diagnostic for rheumatic disease, ANA tests seem to fail the FDA's own definition of clinical utility: "relevance and usefulness of an intervention in patient care."

At least partly due to "ongoing controversy" about clinical utility, "many clinicians have been reluctant to use new diagnostics," notes the FDA in a new report on personalized medicine. Information overload also makes it difficult to adopt new tests, it adds, without "decision­ support tools" to help identify, order, and interpret appropriate tests.

The analysis of approved biomarker tests, published by John Audette, CEO of the biotech consulting firm Amplion Inc., is based on records in the company's online compendium of biomarkers, Biomarker Base. It shows that far and away the most FDA-approved biomarker panels today are relevant to rheumatic disease (see graph below).

(The analysis does not include single-lab or laboratory diagnostic tests not distributed through hospitals or large diagnostic testing companies, which FDA does not yet regulate--though the agency is looking into it.)

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The focus of the Precision Medicine Initiative announced by President Barack Obama in his State of the Union Address is cancer, which ranks a distant third in Amplion's list of currently approved biomarker panels. This new focus is due to cancer's "especially feared ... lethality ... and ... often toxic or disfiguring therapies," say the current and past heads of the National Institutes of Health, Francis Collins MD PhD and Harold Varmus MD, in an editorial published last week in the New England Journal of Medicine.

In the FDA's own report on the topic (Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development), rheumatology doesn't even figure among specialties for which the agency has been reviewing proposals in the "personalized medicine space" (see graph below).

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Nor does rheumatology rate a specific mention in the text of either the NEJM editorial or the FDA report. But watch out: Both the NIH directors in and the FDA itself are promising strong support for innovation in testing, as part of the Precision Medicine Initiative.