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Australia's Genetic Technologies Restructures to Focus on US MDx Space

NEW YORK (GenomeWeb) – Australian molecular diagnostic firm Genetic Technologies today announced a restructuring aimed at ramping up its US molecular diagnostic operations and commercializing the new version of its BrevaGen breast cancer risk test.

As part of the restructuring, its board has approved the sale and/or divestment of the company's non-core assets, as well as the "realignment of internal cost structures through a disciplined approach to cost management and capital allocation," the company said. Also, the board has been restructured and new directors have been appointed to support and enhance Genetic Technologies' US strategy, and the company may change its name to reflect a molecular diagnostic focus.

The company said it plans to complete the changes during the next quarter.

In support of its plans, Genetic Technologies has finalized commitments for a A$2.15 million (US$1.94 million) financing from the issuance of unlisted secured debt notes to existing and new Australian institutional and wholesale investors. Proceeds from the financing will go toward Genetic Technologies' short-term capital requirements in support of its US molecular diagnostic plans. Lodge Corporate was the exclusive placement agent for the transaction.

The company said that it anticipates additional funding and cost benefits over the next quarter from the planned sale of non-core assets, which it did not identify.

Genetic Technologies also said that it plans to launch the next generation of its BrevaGen test next month. The company acquired the original test as part of Genetic Technologies' buy of Perlegen's assets in 2010 and launched the assay the following year. BrevaGen is currently for use only for Caucasian women.

In October, the company plans to launch the new version of the test called BrevaGenplus, which would have use for African-American and Hispanic women, as well as Caucasian women, the company said. The test was developed with US and Australian academic and research centers "and provides a more reliable and accurate assessment of a patient's breast cancer risk."

Genetic Technologies estimates the US addressable market for BrevaGenplus to be greater than 7 million women, and the company plans to conduct clinical utility studies to demonstrate the test's benefits to patients, clinicians, and insurers. The studies will be designed to provide data to expand the test into clinical practices.

In a statement, Genetic Technologies CEO Alison Mew said BrevaGenplus "will deliver improved outcomes over our first-generation test and will, very importantly, be applicable for each of the major ethnic groups in the United States. Not only will this make physicians more likely to use and recommend the test, but it will also greatly simplify the sales and marketing efforts required to support the enhanced product."

The company, which has brought patent infringement litigation against numerous firms during the past few years, said that it will "maintain its patent assertion program based on its non-coding patent estate, in a revised, targeted and cost-effective manner."

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