Genomic Health’s Oncotype DX is a laboratory test that quantifies the likelihood of breast cancer recurrence in women with certain types of early-stage invasive breast cancer. The coverage decision covers women with node-negative breast cancer who have estrogen-receptor-positive tumors. The test must be used within 6 months of diagnosis. Intent to treat or not treat with adjuvant chemotherapy should be contingent, at least in part, on the test results. Coverage is scheduled to become effective for claims deriving from services performed on or after February 27, 2006.
The decision was issued by the National Heritage Insurance Company (NHIC), the contractor administering Medicare programs in California. Medicare bills for Oncotype DX are billed through NHIC because the test is conducted by Genomic Health in its Redwood City, CA, clinical reference laboratory.
Genomic Health announced on January 27 that the FDA has invited the firm to a meeting in order to discuss the regulatory status of the company’s technology. Oncotype DX entered the market in 2004. The FDA had indicated in December 2004 and in 2005 that it was evaluating whether Oncotype DX was subject to premarket regulatory review.

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