ACLPS Resolution: Exclusive Licenses for Diagnostic Tests

Approved by the ACLPS Executive Council, 06/03/99



Use of patents and exclusive licenses to limit diagnostic testing Many disease-causing genes have been discovered in recent years. These discoveries are frequently made available to the public in the form of diagnostic genetic tests developed by clinical laboratories and offered as clinical services. In many instances, patents have also been granted for these discoveries. In some cases, the holders or licensees of these patents have sought to monopolize these tests, and are attempting to force all other health-care facilities to stop performing these medical procedures.

For example, Athena Diagnostics has obtained exclusive licenses from universities to perform diagnostic testing for Charcot-Marie-Tooth disease, apolipoprotein E genotyping, and spinocerebellar ataxia type 1, and has forced other clinical laboratories to stop performing these tests. Myriad Genetics has forced clinical laboratories to stop testing for BRCA1 and BRCA2 mutations. SmithKline Beecham recently tried to use an exclusive license agreement to prevent all other laboratories from performing diagnostic testing for hereditary hemochromatosis, and modified this position only under pressure.


ACLPS believes that:

ACLPS recommends that:


Merz JF. Disease gene patents: overcoming unethical constraints on clinical laboratory medicine. Clinical Chemistry 1999; 45:324-330.

Association for Molecular Pathology. Letter to Dr. Francis Collins, November 8, 1998.

Tait JF. Exclusive licenses for home-brew genetic tests. Some questions and answers. Unpublished document of the Department of Laboratory Medicine, University of Washington, December 23, 1998.