Food and Drug Administration

Center for Biologics Evaluation and Research

Recommended Reading

for the

Oncologic Drugs Advisory Committee Meeting

December 5, 2001


The Development of Diagnostic Immunohistochemistry (IHC) and Fluorescence in situ Hybridization (FISH) Assays Intended to Identify Patients Who Might Benefit from Treatment with a Particular Therapeutic Product


Focus on Characterization and Interpretation of Assay Results







Additional References:

O’Leary, Timothy J. Standardization in Immunohistochemistry. Applied Immunohistochemistry and Molecular Morphology 9(1): 3-8, 2001.

Test and Technology Transfer Committee: Watson, Michael S., Buchanan, Philip D., Cohen Maimon M., DeWald, Gordon W., Ledbetter, David H., Goldberg, James D., Wapner, Ronald J. Technical and clinical assessment of fluorescence in situ hybridization: An ACMG/ASHG position statement. I. Technical considerations. Genetics in Medicine: 2(6), 2000.

Barker, Peter E., Watson, Michael S., Ticehurst, John R., Colbert, Jennifer C., O’Connell, Catherine D. NIST Physical Standards for DNA-Based Medical Testing. Journal of Clinical Laboratory Analysis, vol 16 (1)- in press, pagination to be determined