Centocor Inc. successfully petitioned the FDA for reclassification ofserum tumor markers in a move that will make approval of theproducts much easier.

The action specifically reclassifies tumor associated antigenimmunoassay systems from Class III to Class II. Now those productswill be subject to 510(k) premarket notification rather than premarketapproval (PMA) regulations, which require costly and time-consuming clinical trials.

The affected in vitro diagnostic (IVD) systems are used to identifyspecific tumor antigens and designed for use along with otherdiagnostic tools for monitoring disease progression or response totherapy, or for detection of recurrence or residual disease. Thereclassification covers use of reagents used to measure, byimmunological techniques, tumor associated antigens in body fluids.

Centocor, of Malvern, Pa., already had approval for its CA 125product for ovarian cancer, and since the reclassification has filed forclearance of the CA 15-3 breast cancer assay to monitor recurrenceof the cancer, said Bruce Carroll, manager of government affairs andpublic relations for Centocor. The company has a total of five IVDsand expects to seek clearance later for the other three, he said.

Not included in reclassification ruling are systems designed to screenfor early detection or diagnosis of cancer in the general population orhigh-risk groups, or disease staging. Also not included are tissuereceptor assays, immunohistochemical stains, or direct tests foroncogenes or other genetic markers. They will continue to requirepremarket approval as Class III devices.

Centocor petitioned the FDA for the changes in April 1995. InDecember 1995 the FDA's Immunology Devices Panel voted 9-0 infavor of the reclassification

In a letter notifying Centocor of the decision the FDA said it"determined that premarket application approval is not necessary toprovide reasonable assurance of the safety and effectiveness of thisdevice and that there is sufficient information to establish specialcontrols to provide such assurance."

Carroll said, "This issue shows if industry has a good argument for"spot" FDA reform the agency is willing to listen and take yourpoints into consideration, and in this case was willing to act on it veryquickly."

A notice announcing the reclassification order is expected to bepublished soon in the Federal Register. n

-- Jim Shrine

(c) 1997 American Health Consultants. All rights reserved.