Foley Hoag Client Genetic Technologies Obtains Approval for U.S. Launch of Breast Cancer Risk Test
June 10, 2011
Foley Hoag LLP client Genetic Technologies Limited has gained certification of its Australian laboratory under the U.S. Clinical Laboratories Improvements Amendments (CLIA), marking the end of preparations required for the Australian company’s U.S. launch of the BREVAGen™ breast cancer test.
The BREVAGen™ test informs clinicians about their patients’ individual, non-familial, sporadic risk of breast cancer. The test helps to better classify women at moderate risk of breast cancer who would potentially benefit from preventive therapy or more intensive monitoring, and it meets the recommendations from the American Cancer Society and the American Society of Clinical Oncologists to determine the five-year and lifetime risk of getting breast cancer.
Certification under CLIA will allow Genetic Technologies Limited’s Australian laboratory to offer compliant high-complexity medical testing services to U.S. patients through its wholly owned U.S. subsidiary Phenogen Sciences Inc. The company also may add further cancer management products in development to its test menu without additional regulatory applications.
“We congratulate Genetic Technologies on securing U.S. approval for this important breast cancer risk test,” said Foley Hoag partner Colin Zick. “This test will be an important component in the early detection of breast cancer risk, and we look forward to working with Genetic Technologies in the future as it continues to develop other new and innovative technologies.”
Genetic Technologies expects to offer the BREVAGen™ test to U.S. physicians and their patients in the coming weeks.
About Genetic Technologies Limited
Genetic Technologies Limited was an early pioneer in recognizing important new applications for “non-coding” DNA (Deoxyribonucleic acid). The company has since been granted patents in 24 countries around the world, securing intellectual property rights for particular uses of non-coding DNA in genetic analysis and gene mapping across all genes in all species. Its business strategy is the global commercialization of its patents through an active out-licensing program and the global expansion of its oncology and cancer management diagnostics portfolio. Genetic Technologies is an ASX and Nasdaq listed company with operations in the USA and Australia. For more information, please visit www.gtglabs.com.
About Foley Hoag LLP
Foley Hoag provides innovative, strategic legal services to public, private and government clients across the globe. We have premier capabilities in the life sciences, healthcare, technology, energy, professional services and private funds fields, and in cross-border disputes. The diverse backgrounds, perspectives and experiences of our lawyers and staff contribute to the exceptional service we deliver to clients ranging from startups to multinational companies to sovereign states. For more information, visit www.foleyhoag.com or follow @FoleyHoag on Twitter.