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Feb 21, 2008 07:56PM
I'm sorry, Urbie--I was wrong. The FDA has not approved Oncotype DX, at least from what I could find on the web today.
I had read that the Amer. Society of Clinical Oncology added Oncotype DX to its guidelines for diagnosis of BC in Oct. 2007; and the National Comprehensive Cancer Network (www.nccn.org) added it to the latest version of their guidelines, issued Jan. 2008.
I had also read some optimistic news from Genomic Health (no surprise!) about increasing numbers of insurance companies providing reimbursement for the test. For example:
which says insurers covering 70% of insured people in the U.S. now reimburse for Oncotype DX. That statement was part of the 4th quarter 2007 financial report from Genomic Health.
Since I am hoping my own insurance company covers the test, I guess I extrapolated all those recent approvals and inferred that the FDA had approved it. Apparently, the company does not even have to have FDA approval in order to market the test, since it's a "clinical laboratory reference service" and is exempt from FDA approval.
FWIW, there was an oncogene test approved by the FDA last year (Feb. 2007): the MammaPrint test. That test is done by Agendia, a company in Amsterdam. I haven't heard anybody here talking about results of that test, though.
Darn. I just hope my onco sent it out anyway. It would really peeve me if they've held off for the past week, waiting for BCBS approval. I'll write 'em a darn check, for pete's sake. My life is at stake here!
2008, IDC, Stage Ia, Grade 2, 0/3 nodes, ER+/PR-, HER2-