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Genetics and Health

Archive for the ‘FDA’ Category

January 15th, 2008

FDA approves breast cancer genetic test

 
The U.S. Food and Drug Administration (FDA) has approved a test that helps in assessing the risk of tumor recurrence and long-term survival for patients with relatively high-risk breast cancer. The TOP2A FISH pharmDx is the first approved device to test for the TOP2A (topoisomerase 2 alpha) gene in cancer patients.
The TOP2A gene plays a […]

By Elaine -- 0 comments

December 15th, 2007

Mammaprint breast cancer test validated in node positive tumors

Further to my articles on FDA approved Mammaprint, Agendia BV, world leader in the rapidly evolving field of molecular diagnostics, announced that an independent international consortium has demonstrated the prognostic power of its MammaPrint breast cancer prognosis test in patients who have 1-3 positive lymph nodes. The data show that MammaPrint can accurately identify a low […]

By Elaine -- 0 comments

October 30th, 2007

Agendia’s Mammaprint® breast prognostic test wins innovation award

Following my article on latest prognostic tests for breast cancer, Dutch firm Agendia BV are leading the field again!  Their Mammaprint®  test is the first microarray to gain FDA approval and now they have won a prestigious award for innovation in the field of breast cancer.
The 2007 Frost & SullivanEuropean Product Innovation Award in the field of biomarker-based […]

By Elaine -- 0 comments

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