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Tuesday, November 21, 2006 3:21:21 AM
"Our scientists have identified several Single Nucleotide Polymorphism (“SNP”) markers whose haploid alleles are predictive for non-response to the Taxol and Carboplatin drug combination.
The next step for OVANOME™ is to be tested in prospective clinical trials. These trials will give the final validation and determine the clinical usefulness of the predictive test. . Our Chief Medical Officer, Hector J. Gomez, MD, PhD will lead the clinical development process.
FDA rules regarding pharmacogenomics testing are still evolving and everyone in the industry is seeking additional guidance from the FDA on this issue. Until OVANOME™ is FDA approved or deemed to not require FDA approval, we plan on generating revenues by developing and testing OVANOME and similar tests for other drugs through physician guided Investigative New Drug studies. Recently, we announced that we have begun a formal evaluation of patient’s and patient samples in conjunction with the Moffitt Cancer Center and associated Groups of specialists."
Ann
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