ACLA will present its views at a special FDA conference on July 19-20 on the appropriate regulatory oversight for laboratory developed tests.  ACLA's statement to FDA on the oversight of laboratory developed tests is available at www.clinical-labs.

Background

Advanced tests developed in clinical reference laboratories have played a critical role in better and more effective care for a wide range of conditions.  Genetic tests, for example, have largely enabled the development of personalized medicine.  Such tests allow earlier identification of disease; predicting the risk of disease before symptoms occur, thus allowing earlier treatment; and helping physicians select the specific medication that will best treat the disease.  Examples include HIV resistance testing; BCR/ABL testing for chronic myelogenous leukemia; Fragile X testing for developmental delays; KRAS mutation testing to reduce or eliminate side-effects of colon cancer treatment; testing to identify how quickly a person's body metabolizes certain drugs, thus permitting more effective dosing and reduced side-effects; and testing for rare genetic diseases like Gaucher, Tay-Sachs, Canavan among so many others.  In addition, advanced diagnostic tests have helped protect the public health of the nation by allowing for the identification of SARs, Avian Flu, West Nile Virus and more recently H1N1.  Although many more examples exist, these underscore why lab developed tests -- and their ability to respond rapidly to new and often menacing health challenges -- should continue to be introduced in a flexible and balanced way.  

SOURCE American Clinical Laboratory Association