Genetic Technologies has received its clinical laboratory permit from the New York State Department of Health (DoH).
Genetic Technologies received a positive Laboratory Evaluation Report with "No significant deficiencies" following an audit of its Melbourne laboratories under New York’s DoH Clinical Laboratory Evaluation Program in July 2013.
With this new permit, Genetic Technologies has now secured permission to provide testing services in all 50 US states.
The company can now test BREVAGen from residents of New York State and cater to the requests from New York physicians to provide the breast cancer test to patients as part of their clinical practice.
Genetic Technologies CEO Alison Mew said this is a wonderful endorsement of the quality of company’s laboratory systems and the validation package provided by its highly qualified staff.
"Importantly, it also allows women across the United States access to BREVAGen™ to deliver comprehensive breast health care," Mew added.
Genetic Technologies’ US subsidiary Phenogen Sciences may appoint its representatives shortly covering New York, with a special focus on New York City.
The company believes that the addition of New York will augment the current market adoption of BREVAGen.
BREVAGen is a first in class, clinically validated risk assessment test for non-familial breast cancer.