Singapore, Feb 16, 2012: Genetic Technologies received the Certificate of Compliance for its Australian laboratory under the US Clinical Laboratories Improvements Amendments (CLIA) regulations as administered by the Centers for Medicare and Medicaid Services (CMS). The Certificate of Compliance follows the successful survey conducted by CMS inspectors of the Company’s Melbourne laboratory in November, 2011. Genetic Technologies’ Melbourne laboratory is the only laboratory in the Southern Hemisphere with a CLIA Certificate of Compliance.
Genetic Technologies received CLIA registration for the Melbourne laboratory in April 2011, enabling BREVAGen™ to enter the 42 US states which do not require additional “out of state licensure”. However, initial registration did not enable entry into the two key markets of California and Florida which, on a population basis alone, represent a significant percentage of the US breast cancer market. The Certificate of Compliance marks a key milestone in clearing the path to market BREVAGen™ into the eight remaining US states: California, Florida, Maryland, Nevada, New York, Pennsylvania, Rhode Island, and Tennessee.
“We are very pleased to receive the Certificate of Compliance for the Melbourne laboratory from the CMS,” said Dr Paul MacLeman, Genetic Technologies’ chief executive officer. “The certificate is an essential component of our business strategy, and we are particularly excited to enter Florida and California as these large markets will enable us to potentially improve clinical outcomes for large populations of women who are at risk of developing breast cancer,” added Dr MacLeman.
Launch preparations for BREVAGen’s™ market entry in California and Florida are now underway with the Company’s wholly-owned US subsidiary, Phenogen Sciences Inc. currently in the process of finalizing sales logistics in these regions. The next significant launch milestone for BREVAGen™ will be to enter New York State, which will require a submission under the Clinical Laboratory Evaluation Program (CLEP) to the New York State Department of Health. The Company is now commencing this process and will update the Market on progress, as appropriate.
The Company’s Australian laboratory is already NATA/RCPA accredited to European ISO standards and thus is now able to service patients in all target markets globally.