[Congressional Record Volume 153, Number 35 (Thursday, March 1, 2007)]
[Senate]
[Pages S2502-S2503]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. KENNEDY (for himself and Mr. Smith):
  S. 736. A bill to provide for the regulation and Oversight of 
laboratory tests; to the Committee on Health, Education, Labor, and 
Pensions.
  Mr. KENNEDY. Mr. President, it's a privilege to join Senator Smith 
today to introduce the Laboratory Test Improvement Act. Our goal is to 
ensure the quality of clinical tests used every day in hospitals and 
doctors' offices across the country. Physicians often base medical 
decisions on the results of such tests, and patients deserve confidence 
that they will not be wrongly diagnosed or given the wrong pill because 
of a faulty test.
  In this era of rapid progression in the life sciences, we are 
learning more and more about the human genome and the genetic basis of 
disease. Genetic tests are now available for over a thousand different 
diseases, and the number is continuing to grow. The tests are being 
used to diagnose illnesses, predict who is most susceptible to specific 
diseases, and identify persons who carry a genetic disease that they 
could pass on to their children.
  Today, doctors often apply different treatments until they find one 
that is effective and safe for a patient. But such a trial and error 
strategy often delays effective treatment and may well cause avoidable 
adverse events. In many cases today, however, clinical tests can enable 
doctors to avoid such errors. Through personalized medicine and the use 
of newly developed genetic tests, doctors are able to give a particular 
drug only to patients in whom it is very likely to be effective and 
safe, and can avoid giving it to patients who might suffer an adverse 
reaction.
  As additional technologies are developed and our knowledge increases, 
clinical testing will become more and more important in guiding medical 
decisions, and it is essential for us to see that the tests meet a high 
standard. We know, however, that patients have received the wrong 
results from some tests. In some cases, the claims associated with 
genetic tests are clearly dubious.
  Last year, Senator Smith chaired a hearing by the Special Committee 
on Aging on a GAO report, which found that some genetic tests sold to 
the public have no scientific merit. Our legislation will give health 
providers and

[[Page S2503]]

patients the best possible information about the analytical and 
clinical validity of all clinical tests. It is our responsibility to 
guarantee that such tests are accurate and reliable, and I urge our 
colleagues to support it.
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