IVD Hall of Fame: Looking Back on the IVD Hall of Fame

Friday, May 31, 2013

Part 18 of IVD Hall of Fame

View part: [ 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 ]

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In examining the illustrious list of tests selected for the first IVD hall of fame, I am struck by what a diverse and remarkable field laboratory medicine is. While one could quibble over the list itself (each with his or her own favorite choices), one cannot take issue with the importance of the tests listed. As the assorted authors of these blogs have clearly demonstrated, these tests have done nothing less than change the face of medicine.

Of particular note are several important themes outlined in the various discussions:  the movement of tests from central labs to point of care settings, the introduction of molecular techniques to bring enhanced diagnostic certainty to complex decision making, and last but certainly not least the introduction of companion diagnostics as a cornerstone to personalized medicine. These themes promise to transform laboratory medicine.

Fifteen selected tests obviously reflect the tip of a very large iceberg.  In a report in 2008 the Lewin Group noted that the menu of laboratory tests in the US was estimated to include more than 4000 choices, a remarkable number which, courtesy of hard work by FDA and the laboratory developed test loophole, has surely grown.   

While in terms of health care spending, tests are small potatoes (representing some 2.3% of total health care costs); we certainly do perform a lot of them. In 2008 Lewin reported 6.8 billion tests performed in the US, some 22 tests per American per year, making us one of the most tested people on the planet.  

In my previous gigs as both a regulatory scientist working for FDA and a member of an evidence based practice group working for the BCBS Association Technology Evaluation Center, my work has always been cost-blind. But as a typical citizen who through health care premiums and taxes pays for my fair share of testing, I cannot but wonder if we are really getting our money’s worth.

Various anecdotal reports suggest from 60 to 85% of clinical decision making is informed by the results of laboratory testing. But there are steady and persistent reports appearing in the medical and lay press suggesting both over and under use of tests. The Choosing Wisely initiative discussed in a previous blog targets some 90 commonly used tests as dubious. I suppose this constitutes the rough equivalent of a hall of shame.

What is impressive about this IVD hall of fame is that most if not all its members have stood the test of time and represent assays that do have established clinical utility that is, put simply, tests with a positive impact on health care outcomes that make a difference.  

A demonstration of clinical utility is unfortunately a missing ingredient in our current regulatory systems; neither FDA nor CLIA requires this information. This gap in the oversight process has not been lost on third party payers, thought leaders involved in the development of practice standards, or the community involved in advancing evidence based medicine, all who appear more than a little interested in filling it.

The quest for clinical utility is important work affecting both health care quality and costs. This should matter to most of us since few will escape the opportunity at one time or another to be tested. And to the extent it is done well, this work will likely determine membership in future halls of fame.

Tags: FDA, IVD, LDTs

Part 18 of IVD Hall of Fame

View part: [ 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 ]

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