Quality Assurance Scientific and Regulatory Issues

Molecular diagnostics represents a unique area for the clinical laboratory 

and Maxim, P. E., The FDA s perspective on the evaluation of tumor marker tests. Clin. Chem. (Winston-Salem, NC) 39, 2439-2443 (1993). 

Chamberlain, J. S., Gibbs, R. A., Ranier, J. E., Nguyen, P. N., and Casky, C. T., Deletion screening of the Duchenne muscular dystrophy locus via multiplex DNA amplification. Nucleic Acids Res. 16, 11141-11156 (1988). 

Cossman, J., Zehnbauer, B., Garrett, C. T., Smith, L. J., and Hanson, L. O., Gene rearrangements in the diagnosis of lymphoma/leukemia Guidelines for use based on multi-institutional study. Amer. J. Clin. Pathol. 95, 347-354 (1991). 

Dhingra, K., Talpez, M., Riggs, M. G., Eastman, P. S., Zipf, T., Ku, S., and Kurzrock, R., Hybridization protection assay A rapid, sensitive, and specific method for detection of Philadelphia chromosome-positive leukemias. Blood 77, 238-242 (1991). 

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