tine practice involve review of data collected in the pilot study and elsewhere by both FDA and a policy-making body, usually at the state level, that is independent of the organization directly responsible for conducting the pilot study. A national oversight body (see Chapter 9) could facilitate collection and dissemination of data from pilot "investigational" studies. An adequately conducted pilot study in one or a few states need not be repeated in others as long as the other state(s) can maintain the same standards of the pilot study in routine operation. The committee also recommends that some mechanism be found to resolve the dilemma posed by the need to demonstrate that the device is safe and effective for its intended use, whether or not it will be commercially marketed.

The preceding sections, as well as other chapters in this report, indicate that genetic tests for screening and other purposes differ in many respects from other laboratory tests. Some federal agencies, particularly FDA, have recognized this by planning special guidance for manufacturers of genetic tests and by inviting geneticists to participate on advisory groups. The committee welcomes such activity and encourages other agencies to do likewise. In particular, the committee recommends a Genetic Device Advisory Panel to provide FDA with continuing and timely access to expert advice. In addition, the Clinical Laboratory Improvement Advisory Council should appoint a subcommittee on genetics to make recommendations on improving the quality of laboratories performing genetic tests under CLIA88.

REFERENCES

Adam, B., and Hannon, W. 1992 (published in 1994). The Centers for Disease Control's infant screening quality assurance program: Overview, accomplishments, and initiatives. In Fullarton, J. (ed.) Proceedings of the Committee on Assessing Genetic Risks. Washington, D.C.: National Academy Press.


Benn, P., et al. 1992. A rapid (but wrong) prenatal diagnosis. New England Journal of Medicine 326(24): 1638-1639.


Centers for Disease Control (CDC). 1992. Morbidity and Mortality Weekly Report 41 (RR-2), February 28.

Congressional Research Service (CRS). 1990. Clinical Laboratory Improvement Amendments of 1988. Washington, D.C.

Collaborative Research Group for Huntington's Disease. 1993. A novel gene containing a trinucleotide repeat that is expanded and unstable on Huntington's disease chromosomes. Cell 72:971983.

Council of Regional Networks for Genetic Services (CORN). 1992. Newborn Screening Report: 1990 (Final report, February 1992).

Cunningham, G. 1992 (published in 1994). California newborn screening program. In Fullarton, J. (ed.) Proceedings of the Committee on Assessing Genetic Risks. Washington, D.C.: National Academy Press.


Federal Register. 1992a. 57 (40), February 28, 1992, Sec. 493.2, p. 7139; Sec. 493.3, p. 7140.

Federal Register. 1992b. 57 (40), February 28, 1992, Sec. 493.17{C}{4}, p. 7141.

Federal Register. 1992c. 57 (40), February 28, 1992, Sec. 493.1709, p. 7184).



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