The Centers for Medicare and Medicaid Services (CMS) has granted clinical laboratories improvements amendments (CLIA) certificate of compliance to Genetic Technologies' Melbourne, Australia laboratory.
The company said in April 2011, it received CLIA registration for the Melbourne laboratory, enabling its BREVAGen to enter the 42 US states which do not require additional out of state licensure.
Genetic said however, the initial registration did not enable REVAGen breast cancer risk stratification test’s entry into the two key markets of California and Florida.
The certificate of Compliance now enabled the company to market its BREVAGen into the eight remaining US states including California, Florida, Maryland, Nevada, New York, Pennsylvania, Rhode Island, and Tennessee.
Genetic Technologies CEO Paul MacLeman said the certificate is an essential component of their business strategy, and they are particularly excited to enter Florida and California as these large markets will enable them to potentially improve clinical outcomes for large populations of women who are at risk of developing breast cancer.
Genetic Technologies’ subsidiary Phenogen Sciences is in the process of finalizing sales logistics in launch preparations for BREVAGen’s in California and Florida.
The BREVAGen is a genetic test panel which 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.