test, such correlations will only occur if the data derived from the test are made freely available to the clinicians treating the patients. Thus, clinical research in the United States always has been intertwined with the practice of medicine by physician investigators in academic medical institutions, and historically, overages obtained from medical practice have been a significant source for investment and operating funds in clinical research.

Furthermore, the practice of gene-based diagnostic tests by academic laboratories on the large and heterogeneous patient populations of the academic medical center generates rich databases of newly detected genetic variations that can be correlated with an array of clinical phenotypes. Such admixed medical practice and research provides important new information about the mutational repertory of specific disease-linked genes, as well as the phenotypic correlations that provide new insights into disease mechanisms and identify potential new targets for therapeutic intervention. Such research is a hallmark of academic medical practice and historically has made enormous contributions to the advancement of medical knowledge and public health.

It also is the case that health professionals, the biopharmaceutical industries, and the public are anticipating eagerly a new era of “individualized medicine” and the application of pharmacogenomics to guide the drug development process and tailor therapeutic interventions to individuals and populations based on known genetic factors predictive of drug efficacy and safety. For industry to exploit this promising potentiality, the development and practice of precise, gene-based diagnostic tests to identify the candidate populations for both drug testing and marketing will be required. The development of new genetic tests will be linked intimately as never before to drug development, testing, and marketing.

Given the rapid development of gene-based diagnostic testing and its increasingly critical role in the practice of medicine, the committee identified a variety of concerns that it believes should be considered in licensing practices on genomic- or proteomic-based diagnostic tests, where inventing around the test may not be possible, including:

  • access for patients;

  • allowing competitive perfection of the tests;

  • facilitating IRB-approved clinical research in academic medical centers regardless of funding sources;

  • facilitating professional education and training;

  • permitting independent validation of test results; and

  • ensuring regulatory compliance.

Although the committee discussed all of the above concerns at length, it was especially concerned with independent validation of genomic- or proteomic-based test results. Certain members of the medical and academic community noted that,



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