Food and Drug Administration

Immunology Devices Panel of the Medical Devices Advisory Committee


September 19, 1997

Daniel W. Chan, PhD, DABCC, FACB

Johns Hopkins University


Thank you for the opportunity to appear before the FDA Immunology Devices Panel. My name is Daniel Chan and I am the Director of Clinical Chemistry at the Johns Hopkins Hospital and Associate Professor of Pathology, Oncology and Urology at the Johns Hopkins University School of Medicine. Today, I am testifying on behalf of the American Association for Clinical Chemistry.

AACC is the principal association of clinical chemists, representing nearly 11,000 professional laboratory scientists working in hospitals, independent laboratories and the diagnostics industry nationwide. As laboratory scientists, we play an active role in the research, development and refinement of many laboratory tests, including serum tumor markers. We also use serum tumor markers for diagnostic, prognostic and monitoring purposes. And, as an Association, we strongly supported the FDA’s reclassification of serum tumor markers from Class III to Class II devices.

Given our members’ extensive involvement with tumor marker testing, AACC would like to offer the following comments on the FDA’s guidance document for the submission of tumor associated antigen premarket notifications--510(k)s--to the FDA. First, I would like to state that AACC fully supports the Agency’s September 19, 1996 "Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications to FDA." We believe this document is well-written, concise and provides appropriate guidance to manufacturers so that they may easily understand what information is required for the FDA to clear such a device for marketing. We are please to note that, as a result of this document, several additional tumor markers have been approved in the last year.

As a professional laboratory society, we believe in the full disclosure of analyte contents and testing methodologies. For example, detailed information should be provided on the nature of the antigen, the antibodies and their binding to the defined epitope(s) on the defined patient populations and with appropriate statistical analysis of the data. Test interpretation should be provided to evaluate clinical outcomes. These data are useful not only for seeking FDA approval, but also in the marketing of the product by the manufacturer. Clinical chemists routinely seek this type of information when they evaluate the performance of a particular tumor marker assay and decide which product to use. We believe that this document provides the appropriate guidance for such FDA submissions.

We would also like to briefly comment on the issue of "me-too" tumor markers. AACC agrees that such tumor markers should be subject to less stringent submission requirements. However, we encourage manufacturers to provide sufficient scientific and clinical information to prove that indeed the marker is "substantially equivalent" to the first approved marker. We realize that this is not always an easy task. For example, from time to time it may be necessary to demonstrate that common epitopes are being used for measurement. Providing the FDA with sufficient clinical data will speed up the review process, as well as the introduction of these new markers to the market.

In summary, AACC strongly supports the FDA guidance document and the reclassification of tumor markers. We believe that good scientific and clinical studies, as outlined in the guidance document, will lead to greater understanding of the use of tumor markers and, ultimately, to improved patient care. Thank you for the opportunity to speak before the panel today. And , if you have any questions, I would be happy to respond to them.

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