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Genetic Technologies Lab Gets Regulatory Approvals in US, Australia

NEW YORK — Genetic Technologies said on Tuesday that its lab has received regulatory approvals in Australia and the US that will enable the commercial launch of its GeneType risk-assessment test for certain cancers and other diseases in those markets.

The test is designed to analyze an individual's personal clinical, family, and genetic data to determine their likelihood of developing breast, colorectal, prostate, and ovarian cancers, as well as coronary artery disease and type 2 diabetes.

The Melbourne, Australia-based company said that its lab has recently received accreditation from Australia's National Association of Testing Authorities and CLIA certification from the US Centers for Medicare & Medicaid Services, clearing the way for a commercial release of the test for healthcare professionals in the two countries this week.

"There is a substantial market opportunity for this [test], and we are excited to leverage our expanded sales and marketing platform to bring this product to market," Genetic Technologies CEO Simon Morriss said in a statement. "This test will provide a proactive assessment test for patients and clinicians with the aim to improve patient outcomes in the long term."

In September, Genetic Technologies partnered with Washington University's Institute for Public Health on a study designed to expand the predictive capability of its GeneType for breast cancer in women of African descent.