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Genetic Technologies Receives Approval to Sell BrevaGen in California

NEW YORK (GenomeWeb News) – Genetic Technologies today announced it has been granted a license from California allowing the Australian firm to sell its BrevaGen breast cancer test in that state.

The Laboratory Field Services Unit of the California Department of Public Health has granted a license to Genetic Technologies' Australian-based laboratory, the firm said. The state represents about 11 percent of the total number of breast cancer incidents in the US with more than 25,000 new cases of breast cancer diagnosed annually, it added.

Genetic Technologies received CLIA registration in April 2011, allowing it to sell BrevaGen in 42 states in the US. In February, it received a CLIA Certificate of Compliance for its Australian lab from the US Centers for Medicare and Medicaid Services, clearing the path to market the test in the eight remaining states.

In addition to California, of the other eight states, Genetic Technologies is cleared to sell BrevaGen in Pennsylvania, Rhode Island, Nevada, Tennessee, and Maryland.

It submitted a licensure application in Florida and said it anticipates approval to sell BrevaGen there shortly and has begun the application process for New York, it said.

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