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Florida Clears Genetic Technologies' BrevaGen for Sale

NEW YORK (GenomeWeb News) – Genetic Technologies today said that its BrevaGen breast cancer risk stratification test has been cleared by Florida for sale in the state.

The Clinical Laboratory Unit of the Florida Agency for Healthcare Administration cleared the test, following similar action by California authorities in July. This leaves New York as the only state where BrevaGen has not been cleared for sale. Genetic Technologies said that it has submitted to the New York State Department of Health, Clinical Laboratory Evaluation Program to offer Out of State Clinical Laboratory services to New York residents, and its application is being reviewed.

Genetic Technologies received CLIA registration last year for its lab.

Citing statistics from the American Cancer Society, Genetic Technologies said Florida has about 15 percent of all breast cancer incidents in the US. The Australian firm's US subsidiary, Phenogen Sciences, has trained and put into place in Florida a regional business manager, and Genetic Technologies expects to start selling BrevaGen immediately in the state.