VICTORIA, Australia,
May 31, 2011 /PRNewswire/ -- Genetic
Technologies Limited (ASX: GTG; NASDAQ: GENE) has received and
processed its first BREVAGen™ clinical sample from a US
patient. This follows last month's receipt of certification
of its Australian laboratory under the US Clinical Laboratories
Improvements Amendments (CLIA) (42 U.S.C. 263a).
The sample was received by Phenogen Sciences, the Company's new
North American subsidiary, where the cheek swab sample was
bar-coded and entered into the Laboratory Information Management
System, before being priority shipped to Australia for processing. Subsequently
the results were made electronically accessible to the Company's
North Carolina offices for
immediate distribution to the requesting physician. All
systems functioned as expected and no infrastructure hurdles remain
to full market availability.
The results enabled the patient's physician to better understand
the personalized risk of non-familial breast cancer, allowing
better management and prevention of disease. The patient is
one of an estimated 1.3 million new patients annually in the US who
could benefit from such a test.
"64 percent of the target patient population will have their
breast cancer risk re-classified as a result of using the
BREVAGen™ test, providing a more personalized and actionable
assessment. Many women will have their peace of mind improved
by being re-classified to a lower risk group while for others, they
will be re-classified to a higher risk group, enabling decisions
regarding increased surveillance or even cancer preventive
therapy," said Mr. Lewis Stuart,
Phenogen Sciences President and General Manager.
Concurrently, Phenogen Sciences has now hired its initial sales
team in preparation for the imminent launch of BREVAGen™.
Now at their inaugural sales symposium, the sales team has
been reviewing all available literature, technical details and
benefits of the test. This has involved Company experts,
external medical faculty and key opinion leaders. Speakers
are part of a more extensive Key Opinion Leader network the company
has been building over the last 12 months. Located in leading
oncology institutions, this network of practicing physicians and
academics will be utilized to strongly position and support the
launch of BREVAGen™ and build the Company's sales.
About BREVAGen™
The BREVAGen™ breast cancer risk stratification test is a novel
genetic test panel that examines a patient's buccal (cheek) swab 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, together with
factors from a standard clinical assessment based on a patient's
family and personal history. These factors combine to give a
clearer picture of an individual woman's risk of developing breast
cancer. The BREVAGen™ test may be especially useful for women at
intermediate risk of developing breast cancer, including those who
have undergone breast biopsies. 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
Company's expectations are forward-looking statements, within the
meaning of 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 Company's 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
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Dr Paul D R MacLeman
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Rudi Michelson
(Australia)
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Seth Lewis (USA)
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Chief Executive
Officer
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Monsoon
Communications
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Trout Group Inc.
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Genetic Technologies
Limited
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+61 3 9620 3333
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+1 646 378 2952
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Phone: +61 3 8412
7000
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SOURCE Genetic Technologies Limited