Genetic Technologies (ASX: GTG, NASDAQ: GENE) is a genetic testing business which, together with an extensive range of international patents and allied research activities, aims at uncovering the impact of DNA on health.
Genetic Technologies (ASX: GTG, NASDAQ: GENE) can now roll out its BREVAGen™ test for sale in the large Californian market with the granting of a licence by the Laboratory Field Services Unit of the California Department of Public Health.
BREVAGen™ is a novel genetic test panel that examines a patient's DNA to detect the absence or presence of certain common genetic variations associated with an increased risk for developing breast cancer.
The test is designed to help physicians assess aggregate breast cancer risk from these genetic markers, plus factors from a standard clinical assessment based on a patient's family and personal history, therefore giving a clearer picture of an individual woman's risk of developing breast cancer.
Based solely on incidence rates, California represents about 11% of the United States’ total breast cancer incidence, with over 25,000 new cases of breast cancer diagnosed annually.
Genetic Technologies will be applying sales and marketing resources to drive test adoption and sales in California 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.
Following the receipt of a certificate of compliance issued by the Centers for Medicare and Medicaid Services, the company has submitted numerous applications for “Out of State Licensure,” which allows BREVAGen™ to also be sold in Pennsylvania, Rhode Island, Nevada, Tennessee, Maryland, and now in California.
Genetic Technologies has also submitted a licensure application in Florida and expects to receive approval to sell BREVAGen™ in this key state shortly.
U.S. breast cancer market – compelling opportunity
The U.S. breast cancer market is around US$600 million and growing, with the incidence of breast cancer to increase by 20% by 2020.
BREVAGen™ is the first clinically validated predictive sporadic breast cancer risk assessment test.
Proactive Investors is a market leader in the investment news space, providing ASX “Small and Mid-cap” company news, research reports, StockTube videos and One2One Investor Forums.