BREVAGen receives approval to sell in California

Melbourne-based Genetic Technologies (ASX:GTG) has been given the go ahead to sell its breast cancer diagnostic, BREVAGen, in the US state of California.

This adds a key state to the company’s plan to sell BREVAGen throughout the United States, with California representing over 10 per cent of the country’s total breast cancer incidence.

“We expect California to be a large and significant market for BREVAGen,” said Dr Paul MacLeman, Genetic Technologies’ CEO. “We will be applying sales and marketing resources to drive test adoption and sales in the State in the coming weeks.”

BREVAGen is an oral swab test that identifies genetic variations that are commonly associated with increased breast cancer risk. It focuses on somatic mutations, rather than hereditary mutations, as does the BRACAnalysis test from Myriad Genetics.

The company gained CLIA (Clinical Laboratories Improvements Amendments) to sell into 42 US states in April last year, and has since posted increased growth in sales for BREVAGen.

It is currently targeting Florida with an Out of State Licensure and expects to receive approval to sell BREVAGen in that state soon, and is in the process of seeking approval to sell in New York.