Mind to Market

Wednesday, February 07, 2007

FDA Approves Breast Cancer Test

As I was writing yesterday's blog, the FDA announced the approval of a genetic prognostic test for breast cancer recurrence. The test MammaPrint was developed by the Dutch company Agendia and is the first in vitro diagnostic multivariate index assay (IVDMIA) device to be cleared by the FDA.

MammaPrint uses a microarray chip to measure the activity of a set of 70 genes the pattern of which will predict whether the cancer will metastasize. Many women who have their tumors removed undergo chemotherapy on the theory that it will reduce their chances of recurrence. Studies have shown however, that most will not experience recurrence and don't need the chemo. However, it was unclear as to which patients would benefit from chemo and which would not forcing many women to needlessly undergo the treatment and its painful side effects. This test promises to make the decision easier and has shown to be 96.7% accurate.

Genomic Health also markets a genetic breast cancer prognosis test called Oncotype DX. Oncotype DX profiles 21 genes using RT-PCR technology. Both tests run between $3,200 and $3,500 and health insurers and Medicare are initiated coverage of Oncotype DX.

The FDA will hold a public meeting tomorrow to discuss its draft guidance describing its regulatory approach to this type of test.

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