FORM 6-K
U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE
SECURITIES EXCHANGE ACT OF 1934
dated June 22, 2011
Commission File Number 0-51504
GENETIC TECHNOLOGIES LIMITED
(Exact Name as Specified in its Charter)
N/A
(Translation of Registrants Name)
60-66 Hanover Street
Fitzroy
Victoria 3065 Australia
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x |
Form 40-F o |
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): o
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): o
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes o |
No x |
If Yes is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): Not applicable.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused the Report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: June 22, 2011
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GENETIC TECHNOLOGIES LIMITED | ||
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By: |
/s/ Thomas Howitt | |
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Name: |
Thomas Howitt |
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Title: |
Chief Financial Officer |
Exhibit 99.1
ASX ANNOUNCEMENT
20 June 2011
Genetic Technologies Launches BREVAGen Breast Cancer Risk Test in US
· A New Breast Cancer Predictive-Risk Genetic Test first mover in substantial market
· Launch by subsidiary Phenogen Sciences Inc in targeted US metro-markets
Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE), through its North American division, Phenogen Sciences Inc., has launched the new BREVAGen genetic test for assessing non-familial breast cancer risk.
Phenogen Sciences will target its promotion campaign on womens health clinics in over 20 US metro-markets. The company has deployed its sales force to service select markets based on high volume use of the BRCA genetic test, currently available for the rarer familial form of breast cancer. The BREVAGen test has an attractive gross margin and an estimated addressable market in excess of $600 million per annum in the US.
The US launch of BREVAGen is the culmination of substantial investment in development encompassing large scale genomic investigations and substantial support in medical literature. It is the first phase of the companys five year strategy to build a global cancer diagnostics business, said Dr. Paul MacLeman, CEO.
Over this same period, GTGs core business has been streamlined; cutting costs, culling poor performing products and delivering its maiden half year profit. GTG has a clear focus on providing the best possible cancer diagnostics in major world markets. The US launch of BREVAGen follows the establishment of core commercial capability in the US and the achievement of CLIA certification for the companys now globally accredited laboratory.
GTG is now also actively assessing new synergistic M&A opportunities with a view to a possible transaction during the coming financial year.
The new BREVAGen genetic test will be combined with individual risk factors to assess a patients five-year and lifetime risk for the more frequent forms of sporadic/non-hereditary breast cancer that represent over 90 per cent of all breast cancer cases in the US.
BREVAGen represents an important advance towards identifying more women who may be at increased risk for developing non-hereditary breast cancer, said Burton S. Brodsky, MD, a practicing OBGYN physician and senior partner at the prestigious da Vinci Obstetrics & Gynecology clinic located in Detroit, Michigan.
Over coming months womens health clinics will begin using BREVAGen tests to collect genetic samples via a simple cheek swab and submit these to GTGs CLIA-certified Melbourne laboratory. Within 2-3 weeks of a swab, physicians will receive a comprehensive and confidential report assessing a patients risk based on genetic and individual risk factors. This will enable the health care provider to develop a more personalized breast cancer prevention plan than has previously been possible.
We are excited to introduce BREVAGen here in the United States and believe this new predictive risk test will significantly enhance a healthcare providers breast cancer prevention strategy, stated Lewis Stuart, President and General Manager for Phenogen Sciences Inc.
About BREVAGen
The BREVAGen breast cancer risk stratification test is a novel genetic test panel that examines a patients blood sample to detect the absence or presence of certain common genetic variations (SNPs) associated with an increased risk for developing breast cancer. The test is designed to help physicians assess aggregate breast cancer risk from these genetic markers, plus factors from a standard clinical assessment based on a patients family and personal history, thus giving a clearer picture of an individual womans risk of developing breast cancer. The BREVAGen(TM) test may be especially useful for women at intermediate risk of developing breast cancer, including those who have undergone breast biopsies, as the test will provide information that can help physicians recommend alternative courses of action, such as more vigilant, targeted surveillance or preventive therapy, on a personalized patient-by-patient basis.
About Genetic Technologies Limited
Genetic Technologies 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.
Safe Harbor Statement
Any statements in this press release that relate to the Companys expectations are forward-looking statements, within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Since this information may involve risks and uncertainties and are subject to change at any time, the Companys actual results may differ materially from expected results. Additional risks associated with Genetic Technologies business can be found in its periodic filings with the SEC.
FOR FURTHER INFORMATION PLEASE CONTACT
Dr. Paul D. R. MacLeman |
Rudi Michelson (Australia) |
Seth Lewis (USA) |
Chief Executive Officer |
Monsoon Communications |
Trout Group Inc. |
Genetic Technologies Limited |
(03) 9620 3333 |
(646) 378 2952 |
Phone: +61 3 8412 7000 |
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Genetic Technologies Limited ABN 17 009 212 328 · Website: www.gtglabs.com · Email: info@gtglabs.com
Registered Office · 60-66 Hanover Street Fitzroy Victoria 3065 Australia · Postal Address P.O. Box 115 Fitzroy Victoria 3065 Australia
Phone +61 3 8412 7000 · Fax +61 3 8412 7040
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