The "signals are very positive" regarding Centocor Inc.'s petition tohave tumor markers reclassified in a way that would make theirapproval easier, a company spokesman said Tuesday.
Last year Centocor petitioned the FDA to change the requirementsfor its tumor markers from Class III, requiring premarket approval, toClass II, which requires the easier 510(k) premarket notification. TheMalvern, Pa., company also sought the reclassification of specialpurpose reagents into Class I status, which means they would besubject only to good manufacturing practices.
In December the FDA's Immunology Devices Panel voted 9-0 infavor of Centocor's petition to reclassify tumor markers to Class II.Centocor has six antibody-based tumor markers for monitoringcancers, but only one is on the market in the U.S.
The panel's recommendation becomes effective after finalization of adraft guideline and publication of a final rule in the Federal Register.
A special advisory panel met last week and recommended the policyof reclassifying special purpose reagents, said Bruce Carroll,Centocor's manager of government relations.
That policy would cover antibodies, antigens and other activeingredients of in vitro diagnostic systems. Presently the reagents arelabeled for research use only. Reclassification would allow Centocorand others to sell the individual ingredients on the market.
Only five in vitro diagnostics (IVD) are approved for use in the U.S.,one of them Centocor's CA 125 for ovarian cancer. Dozens of IVDsare available on the worldwide market.
Final approval would ease the industry's ability to make theseproducts available to the public, Carroll said.
"Research into products like these are building blocks to therapeuticproducts. It's important to have that type of science encouraged in theU.S."
Carroll said current Class III regulations for tumor markers make itdifficult on financial and scientific levels, where studies to documentclinical utility can take years and cost millions. "We keep making thecase that the regulations don't fit the technology. We're talking abouta laboratory test," he said.
In addition to working on reclassification of tumor markers andspecial purpose reagents, Centocor's third push is in the legislativearea, bringing the issue to the attention of House and Senate memberswho are considering FDA reform legislation, Carroll said.
Centocor has no information on timelines for the proposed changes,Carroll said.
David Holveck, Centocor's president and CEO, said of the tumormarkers recommendation: "This vote represents something of anhistoric change in the regulation of in vitro diagnostic products. Forthe first time in 22 years, FDA will have the opportunity to apply aflexible and appropriate level of regulation to these tests." n
-- Jim Shrine
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