MELBOURNE, AUSTRALIA -- (Marketwire) -- 07/26/12 -- Genetic Technologies Limited (ASX: GTG) (NASDAQ: GENE) is pleased to announce that the Laboratory Field Services Unit of the California Department of Public Health (CDPH) has granted a license to the Company's Australian-based laboratory. BREVAGen™ may now be offered forhe State of C sale into talifornia.
Based solely on incidence rates, California represents approximately 11% of the United States' total breast cancer incidents, with over 25,000 new cases of breast cancer diagnosed annually. (ACS Breast Cancer Facts & Figures 2011-12, ACS Cancer Facts & Figures 2012)
We expect Califoro be a large and significant market for BREVAGen™," said Dr. Paul MacLeman, Genetic Technologies' Chief Executive Officer. "We will be applying sales and marketing resources to drive test adoption and sales in the State in the coming weeks."
U.S. State Certification
In April 2011, Genetic Technologies successfully attained CLIA approval, allowing BREVAGen™ to be sold into 42 U.S. States (see ASX announcement dated April 27th, 2011). Following the Company's receipt of a certificate of compliance issued by the Centers for Medicare and Medicaid Services (see ASX announcement dated February 16th, 2012), the Company has submitted numerous applications for "Out of State Licensure," which allow BREVAGen™ to also be sold in Pennsylvania, Rhode Island, Nevada, Tennessee, Maryland, and now in California. The Company has also submitted a licensure application in Florida and expects to receive approval to sell BREVAGen™ in this key State shortly.
The Company has commenced serial submission of an application to submit to the New York State Department of Health, Clinical Laboratory Evaluation Program (CLEP) to offer Out of State Clinical Lab Services to New York State residents.
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