NEW YORK (GenomeWeb News) – Genetic Technologies today said that it has received a CLIA Certificate of Compliance for its Australian lab from the US centers for Medicare and Medicaid Services.
The firm said its lab in Melbourne, where the firm also is based, is the only lab in the Southern Hemisphere with a CLIA Certificate of Compliance. The lab had received CLIA registration in April 2011.
Genetic Technologies markets its BrevaGen test, a risk stratification panel for determining an increased risk for developing breast cancer, to 42 states in the US that don't require additional out-of-state licensure, it said. The firm added that the certificate of compliance clears a path to market the test in the remaining eight states, which includes the key states of California, Florida, and New York.
Genetic Technologies said that launch preparations are underway in Florida and California through its US subsidiary, Phenogen Sciences. It added that the "next significant milestone" for the BrevaGen test is entering the New York market, which will require clearance from the New York State Department of Health.
"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," Genetic Technologies CEO Paul MacLeman said in a statement.