Sunday, June 13, 2010
The Food and Drug Administration is issuing regulatory letters for Genomic Test
WASHINGTON -- 46th DIA (Drug Information Association) Annual Meeting -- The Food and Drug Administration is regulatory letters for Genomic Test. This is the first sign that the government is recognizing companies like Hybrid Pharmaceutical Inc that use DNA samples to predict Breast Cancer and inheritable diseases.
The FDA letters state that genomics tests are considered
medical devices and must be federally approved as safe
and effective.This is great news for Hybrid Pharmaceuticals
and the nascent personal genomics industry and our customers.
Washington DC has the highest Stage IV Breast Cancer Rate
in the US. A genomic test looks looks at 21 genes in a
patient's breast tumor and how active they are. Our focus is
on Genomic Trials. Genomics Science looks at groups of genes
and how active they are. This activity can influence how
a cancer is likely to grow and respond to treatment. Unlike
a genetic test, that provide information about a person’s
inherited genetic make-up. Instead,Hybrid Pharmaceuticals
looks at 21 genes in a patient’s breast tumor trials to
understand how these genes interact and influence the tumor’s
behavior.
85% of Breast Cancer Patients that get a Genomics Personalized
test will enable Oncologist to recommend that right treatment.
instead of the 50% of Breast Cancer Patients that get Toxic
Chemotherapy.
BR Graham Editor
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