Genetic Technologies Limited (ASX: GTG; NASDAQ Ticker: GENE) is
delighted to announce that following substantial scientific
research and genetic product development, two new ground-breaking
cancer risk assessment tests have now been completed and validated.
The tests are branded as ‘
GeneType for Colorectal
Cancer’ and ‘
GeneType for Breast Cancer’
– see below:
Image 1, What is GeneType for Colorectal
Cancer?:
http://www.globenewswire.com/NewsRoom/AttachmentNg/a20ba1cf-ead8-4047-bb31-be67a8a91aa3
Image 2, What is GeneType for Breast
Cancer?: http://www.globenewswire.com/NewsRoom/AttachmentNg/cefef8c1-5543-430a-ab3c-c0a7144600fc
The new tests for colorectal cancer and
breast cancer are world-leading.
GTG’s polygenic risk tests combine information
from genetic markers called Single Nucleotide Polymorphisms to
assess how people’s genetic make-up affects their risk of
developing various diseases. GTG’s heavily patented approach to
incorporating further clinical risk information places them at the
forefront of the global risk assessment space.
The new breast cancer test provides substantial
improvement over GTG’s legacy breast cancer test (which was called
BREVAGenplus) by incorporating multiple additional clinical risk
factors. This test will provide healthcare providers and their
patients with a 5-year and lifetime risk assessment of the patient
developing breast cancer.
The world-first polygenic risk test for
colorectal cancer provides healthcare providers and their patients
a 5-year, 10-year, and lifetime risk assessment of the patient
developing colorectal cancer.
Importantly, GTG’s new risk tests and the
resulting detailed healthcare provider and patient reports empower
those people at increased risk to make specific lifestyle changes
to reduce their particular risks and improve ongoing early future
disease detection.
GTG Chairman and Acting CEO Dr Paul Kasian said,
“These tests allow Government Health Leaders to directly target
future screening to the most high-risk patients, thereby massively
reducing health system costs and providing much better outcomes for
patients. GTG’s proactive approach to disease management has the
potential to save both lives and money by allowing the earlier
detection of disease and focusing the use of limited healthcare
resources to those most in need.”
Dr Kasian added, “I am very proud of our
world-class scientific team. Genetic testing is a growing industry
world-wide and it is remarkable that the team has maintained
thought and product development leadership in this competitive
space. Armed with these new world class products, GTG is poised to
play its part in making predictive genetic testing a mainstream
healthcare activity – a routine part of any health check-up.”
New Product – ‘GeneType for Colorectal
Cancer’
Next generation risk assessments combine
multiple clinical and genetic risk factors to better stratify
individuals at increased risk of developing disease.
‘GeneType for Colorectal Cancer’ incorporates the
most impactful risk factors in order to define an individual’s risk
of developing colorectal cancer, so the healthcare provider can
make screening and preventative care recommendations that are
tailored to their patient’s personalised risk.
Colorectal cancer is the 3rd most commonly
diagnosed cancer in the US, yet 1 in 3 adults are not receiving the
appropriate colorectal cancer screening for their age. In addition,
rates of colorectal cancer among 20-49 year olds is steadily
increasing. Identifying patients who are most at risk for
colorectal cancer can lead to enhanced screening protocols and
better outcomes. Most individuals diagnosed with colorectal cancer
do not have a significant family history of the disease.
‘GeneType for Colorectal Cancer’ evaluates the
genometric risk of developing colorectal cancer for men and women
over age 30 who do not have a known pathogenic gene variant.
Polygenic risk identifies patients at
unusually high risk of disease
In sporadic colorectal cancer, no single gene
mutation is causal of disease. Rather, common DNA variations,
called single nucleotide polymorphisms (SNPs), each contribute a
small but measurable risk of developing disease. ‘GeneType
for Colorectal Cancer’ analyzes a patient’s DNA for 40+
SNPs that have been clinically validated in their association with
colorectal cancer. By combining the effects of all of these SNPs
into a single polygenic risk score (PRS), ‘GeneType for
Colorectal Cancer’ provides a superior risk stratification
over standard risk assessments that incorporate only clinical
factors.
‘GeneType for Colorectal
Cancer’ is clinically validated for men and women 30 years
of age or older and for individuals of Caucasian descent. Genetic
Technologies will provide updates as we continuously improve our
test and add fully validated models for additional
ethnicities.
New Product – ‘GeneType for Breast
Cancer’
Germline genetic testing for mutations in BRCA1
and BRCA2 allows for the identification of individuals at
significantly increased risk for breast and other cancers. However,
such mutations are relatively rare in the general population and
account for less than 10% of all breast cancer cases.
The remaining 90% of non-familial or sporadic breast cancer have to
be defined by other genetic/clinical markers common to the
population at large and this is where Genetic Technologies has
focused its attention.
The
newly developed ‘GeneType for Breast Cancer’ test
is aimed at risk detection of non-BRCA related sporadic breast
cancer (that is, for those women who do not have an identified
family history of breast cancer). Importantly, this means
that Genetic Technologies’ test covers 95% of women - see
below:
Image 3, Detecting non-BRCA related sporadic breast
cancer: http://www.globenewswire.com/NewsRoom/AttachmentNg/6bb27727-a78f-4934-8782-964edbb2b4bb
The key features of Genetic Technologies’ new
‘GeneType’ tests are as follows:
- they are based upon world-leading science
- patients identified as being at increased risk can be offered
increased ongoing targeted screening, protecting them against the
poor health outcomes and high costs from late diagnosis of
disease
- GTG’s scientific team has perfected concise patient
questionnaires, so as to minimize clinical consultation times for
busy health practitioners (lengthy time-consuming questionnaires
have been a widespread weakness with non-Genetic Technologies
sourced polygenic risk score tests
- unlike many other genetic tests, GTG’s products are modest in
price, making them affordable to all so that they can become a key
part of regular healthcare provider health checks and a core
component of Government health cost reduction programs
- importantly, the tests also empower healthcare providers to
work with patients on lifestyle changes which can reduce both
colorectal and breast cancer risk
- the Intellectual Property is supported by a strong global
(including the US) patent portfolio
Commercialization and Product
Distribution Plans
GTG intends to introduce the new
‘GeneType for Colorectal Cancer’’ and
‘GeneType for Breast Cancer’ genetic tests to
healthcare providers through a global network of distribution
partners. The Company has already announced it is working with TGen
in the United States and also Chinese partners connected to the
Hainan Free-Trade Zone. More announcements are anticipated in this
regard in coming months as GTG moves to commercialize its suite of
world-leading genetic tests.
Following the successful completion of the
‘GeneType for Colorectal Cancer’ and
‘GeneType for Breast Cancer’ genetic tests, GTG’s
Scientific and Product Development Team will refocus on the future
pipeline of exciting new tests detailed below and as previously
announced to the market.
Image 4, New Test Pipeline:
http://www.globenewswire.com/NewsRoom/AttachmentNg/8aeb5a80-3cea-4066-9fd6-e27e7b6e0e8f
FOR FURTHER INFORMATION PLEASE CONTACT
Dr Paul KasianChairman and CEOGenetic
Technologies+61 3 8412 7000
Mr Paul VineyCOO, CFO and Company
SecretaryGenetic Technologies+61 438 072 616
Investor Relations and Media (Australia)Ms
Karinza PhoenixStocksDigital+61 428 981
074karinza@stocksdigital
Investor Relations and Media (US)Mr Dave
GentryRedChipOffice: 1 800 RED CHIP (733 2447)Cell: 407 491
4498dave@redchip.com
About Genetic Technologies
Limited Genetic Technologies Limited (ASX: GTG;
Nasdaq: GENE) is a diversified molecular diagnostics company. GTG
offers cancer predictive testing and assessment tools to help
physicians proactively manage patient health. The Company lead
products GeneType for Breast Cancer and
‘GeneType for Colorectal Cancer’ are clinically
validated risk assessment tests for non-hereditary breast cancer
and are first in class.
Genetic Technologies is developing a pipeline of
risk assessment products.
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. 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. 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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