Genetic Technologies gains access to full US market for BREVAGen

Updated 21-02-12

Genetic Technologies Group (ASX:GTG) has cleared a roadblock on the path to allowing its BREVAGen breast cancer risk assessment test to be sold in all 50 states of the USA.

The company has received a CLIA (Clinical Laboratories Improvements Amendments) Certificate of Compliance for its Melbourne laboratory from the US Centers for Medicare and Medicaid Services (CMS).

The facility is the only laboratory in the Southern Hemisphere to have received a CLIA compliance certificate.

The CLIA certificate was required to launch products developed by the laboratory in eight US states, including the key breast cancer diagnostics markets of California and Florida.

Genetic Technologies received initial CLIA registration for the laboratory in April last year, which grants its products access to the remaining 42 states.

The company next plans to pursue a launch in New York State, which will require additional approvals from the state's Department of Health. The laboratory is already NATA/RCPA accredited to European ISO standards.

BREVAGen is an oral swab test designed to calculate an individual's genetic risk of breast cancer by detecting differences in certain genetic variants.

Genetic Technologies stirred up controversy in 2008 when it announced it would begin enforcing its exclusive rights to conduct BRCA1 and BRCA2 breast cancer diagnostic tests in Australia. Although the company later revealed it would suspend all enforcement activities, the ensuing scandal led to the replacement of then-CEO Michael Ohanessian and several directors.

In 2010, the company filed a patent infringement suit against nine US biotech companies relating to non-coding DNA technologies. That same year, the validity of Genetic Technologies' and other companies' patents relating to genetic material was challenged in court.

A court case challenging the patents held by Genetic Technologies and Myriad Genetics began yesterday in the Federal Court in Sydney, brought by Yvonne D'Arcy and Cancer Voices Australia. Genetic Technologies is the exclusive license holder of the patent concerning the BRCA1 gene in Australia.

The case challenges the patents held by the companies on the grounds they are discoveries not inventions. The hearing is expected to last a week.

Genetic Technologies (ASX:GTG) shares fell 3.7% in Friday's trading at $0.130.