Genetic Technologies Limited (ASX: GTG, NASDAQ: GENE) today
reported early insights from the US regional launch of BREVAGen™,
its new, easy-to-use, predictive risk test for the tens of millions
of women at intermediate risk of developing breast cancer. The
Company’s US-based subsidiary, Phenogen Sciences Inc.,
(http://www.phenogensciences.com) began its progressive roll-out of
BREVAGen™ to obstetricians and gynecologists in eight metropolitan
areas in the third quarter of 2011, with anticipated territory
expansion in the coming months. BREVAGen™ is the first clinically
validated breast cancer predictive risk assessment tool that
combines a woman’s genetic information with clinical data to assist
physicians in developing personalized risk management plans.
Mr. Lewis J. Stuart, President of Phenogen Sciences Inc., said
“The early response to BREVAGen™ has been positive, particularly in
those practices with a strong orientation toward breast cancer
prevention. We are adjusting the way physicians think about breast
cancer risk and how it relates to all women, not just those with
known high-risk genes. While this requires additional education,
BREVAGen™ has been designed to fit nicely into current clinical
risk assessment guidelines, simplifying in-office implementation of
the test.”
Over the first 90 days, the Phenogen sales team made more than
2,800 sales calls, reaching 800 physicians, representing good
penetration into its initial tier one targets. During this same
timeframe, 600 test kits were placed in targeted accounts,
resulting in early adopter BREVAGen™ use within two weeks of
launch.
The Company has commenced processing re-imbursements on initial
BREVAGen™ test sales. As part of a longer term insured lives
contracting and credentialing strategy, the Company has also
commenced the credentialing process with the US’ top-10 preferred
provider organizations (PPO), which represent more than 60 percent
of covered lives in the US. In the last two weeks, the first PPO
contract was finalized with additional contracts anticipated to be
completed by the end of the quarter.
Added Stuart, “Experience from the initial roll-out has allowed
us to validate and refine our marketing strategy and proceed into
the broader market with greater certainty.”
“For the first time, BREVAGen™ allows clinicians to make
informed decisions for the vast majority of patients with
non-familial or sporadic risk of breast cancer based on their
personal genetics, not simply a statistical risk score,” said Dr.
Eric Jacoby, Senior Partner at Personalized Women’s Healthcare, in
Plano, Texas. Dr. Jacoby added, “The results I receive from the
BREVAGen™ test are making it much easier for the patient and I to
decide on an appropriate level of monitoring and, if necessary, a
more intensive surveillance plan of action including Magnetic
Resonance Imaging or chemoprevention.”
According to Dr. Owen Winsett, Founder and General Surgeon at
The Breast Center of Austin, Texas, “Practices that are proactive
in measuring breast cancer risk will welcome the addition of this
in-office individualized risk assessment tool. We are passionate
about breast cancer prevention, and BREVAGen™ provides a critical
piece of the risk assessment puzzle. BREVAGen™ is an easy to
perform and interpret test to give us information on whom we should
provide closer monitoring and screening.”
How BREVAGen™ works
The BREVAGen™ predictive risk test is administered in a
physician’s office using a simple, non-invasive “cheek-swab”.
Following analysis in a CLIA-certified laboratory, physicians
receive a comprehensive predictive risk assessment report to review
with the patient. The patient’s risk of breast cancer is calculated
by combining their relative risk score from seven genetic markers,
called SNP’s (single nucleotide polymorphisms), with their Gail
score (factors that comprise the patient’s clinical make-up
including current age, age at menarche, age at live first birth,
race/ethnicity, etc.).
The BREVAGen™ test provides five-year and lifetime predictive
risk assessments to more accurately evaluate the patient’s risk for
developing breast cancer, regardless of family history or previous
indeterminate test results.
Clinically validated, proven superior risk assessment
BREVAGen™ has been proven superior in determining breast cancer
risk compared to the Gail score alone.1 In the U.S. Women’s Health
Initiative (WHI) Clinical Trial, 3,300 women underwent breast
cancer assessment utilizing the BREVAGen™ test. Of those 3,300
women, 1,664 were diagnosed with breast cancer and 1,636 were in
the breast cancer-free control group.
BREVAGen™ is clinically validated to reclassify approximately
64% of women in the intermediate Gail breast cancer risk group
(being those with a 1.5% to 2.0% five-year risk), with
approximately 28% being reclassified as higher risk candidates for
breast cancer.1 A preventive treatment plan based on this would
prevent about 50% of cancers in this group. In addition, more than
36% in this group will be re-stratified down, avoiding unnecessary
treatment, side effects and costs. Therefore, approximately one in
two patients in the intermediate Gail risk group will have their
standard of care changed for the better.
About Phenogen Sciences Inc.
Phenogen Sciences Inc., the US division of Australia-based
Genetic Technologies Limited, is a pioneer in personalized
healthcare. Phenogen provides physicians and patients with
personalized medical information, risk assessments and insights for
patient-specific health management in the areas of oncology and
women’s health. Phenogen’s lead product, BREVAGen™, is the first
predictive test that combines clinical information and genetic
factors to categorise a woman’s personal risk of developing breast
cancer. For more information, visit
http://www.phenogensciences.com.
1 Mealiffe M., Stokowski R.P., Rhees B.K. et. al. J Nat Cancer
Inst. 2010; 102(21): 1618-1627
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 (USA)
Any statements in this press release that relate to the
Company’s expectations are forward-looking statements, within the
meaning of the United States 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 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.
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