Genetic Technologies’ breast cancer test gets clearance for sale in Florida, shares rally
Shares of the company were ahead 19.58 per cent as at about 11:30 a.m. ET, trading at $4.01.
Genetic’s BREVAGen breast cancer risk stratification test examines a patient's DNA to detect the absence or presence of certain common genetic variations (SNPs) associated with an increased risk for developing breast cancer.
The company said the test is designed to help physicians assess breast cancer risk from these genetic markers, plus factors from a standard clinical assessment based on a patient's family and personal history, thus giving a clearer picture of an individual woman's risk of developing the disease.
Genetic said that the clearance came following the grant of a permit to the company’s Australian-based laboratory by the Florida Agency for Healthcare Administration (AHCA).
In July, the company said it received clearance of BREVAGen for sale into California.
“Combined, Florida and California represent between 15 and 20 per cent of breast cancer incidence in the U.S.,” the company said in a statement Tuesday.
Genetic said that a regional business manager has already been trained and put into place in Florida by the company’s U.S. subsidiary, Phenogen Sciences Inc.
Having pre-qualified several key accounts in the territory already, the company said it expects to immediately start sales in the region.
Genetic has successfully attained approval allowing BREVAGen to be sold into 42 U.S. States. It said it has also has submitted numerous applications for "out of state licensure”, which allows BREVAGen to now also be sold in Pennsylvania, Rhode Island, Nevada, Tennessee, Maryland, California and Florida.
The company has submitted an application along with supporting test documentation to the New York State Department of Health, to offer out of state clinical lab services to New York State residents.
Genetic said that the application is under review, and once New York State approval is granted, the BREVAGen test will have been cleared for sale in all 50 U.S. States.
The company said the test may be “especially useful” for women predisposed to hormone dependant breast cancer, including those who have undergone breast biopsies.
The test will provide information that can help physicians recommend alternative courses of action, such as more vigilant, targeted surveillance or preventive therapy, on a personalized patient-by-patient basis.
Genetic Technologies is a diagnostics company focused on the commercialization of its patent portfolio through an active out-licensing program and the global expansion of its oncology and cancer management diagnostics assets.
Its U.S. subsidiary, Phenogen Sciences, offers predictive testing and assessment tools to help physicians proactively manage women's health.