Health
FDA OKs new cancer predictor
NEWS IN BRIEF — Posted Feb. 26, 2007
The Food and Drug Administration on Feb. 6 approved a test that helps determine the likelihood of breast cancer returning within five to 10 years after a woman's initial cancer. It is the first such molecular test, which profiles individual genetic activity, to be approved for sale by the agency.
Called the MammaPrint, the test relies on microarray analysis to predict whether existing cancer will metastasize, thus helping to guide treatment decisions.
Other similar tests are available at certain venues, but none have been approved by the FDA. The agency had announced its intention several months ago to change its regulatory scope and include tests developed and performed by a single laboratory. MammaPrint's approval is the result. Previously, the agency had reviewed tests offered for sale to hospitals, physicians and labs.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2007/02/26/hlbf0226.htm.