20 Medical centers across 8 US states set to offer Breast Cancer Test
Molecular diagnostics company Genetic Technologies Limited (ASX:
GTG, NASDAQ: GENE) is pleased to advise that its third-generation
breast cancer test (GeneType for Breast Cancer) is on track for
commercial release in the Unites States (US) in Q1 2020.
Genetic Technologies expects to take advantage
of the growing confidence and interest in genomic testing, and its
first to market status in the US market. GeneType for breast cancer
(BC) is on track for release in the US in Q1 (2020) via a soft
launch across 20 centres in 8 States, which demonstrates the strong
support from practitioners for the introduction of the company’s
third generation test incorporating mammography data. The Company
anticipates a full launch in Q2 (2020).
CLIA Accreditation across 50
Following a successful CLIA audit in December
2019, the Company now has continuing CLIA certification for its
laboratory developed tests in all 50 States in the US and also
maintains licenses in all individual States that require
supplemental accreditation including New York. In addition, the
company’s current 35,000 test laboratory capacity has the ability
to be scaled up in line with demand.
There is now significant maturity in industry
acceptance of polygenic risk scores as a tool for measuring the
risk of cancer and other common complex diseases. Over 300 papers
have been published in the past 12 months - up from one in 2012,
which was GTG's original paper which stemmed from its involvement
in the human genome project.
BC polygenic risk was originally identified in
Genome Wide Association studies (GWAS) comparing hundreds of
thousands of BC cases to controls (no BC). This work has since then
been cross validated in numerous international consortia consisting
of tens of thousands additional women (case/controls cohorts).
Only 1 in 500 women carry a BRCA mutation,
representing 0.2% of the population. GeneType for BC will help
classify the other 99.8% of women into risk categories. Women
identified as high risk will, together with their practitioners,
now have the opportunity to choose supplemental screening and
prevention options to meet their breast health needs.
The company’s test is uniquely placed to
accurately predict BC risk, with the ability to identify low (1/5
of average risk) as well as high (5 x average risk) risk patients
from the age of 35.
Furthermore, the addition of mammography data to
the GeneType for BC test enables the ability to better stratify
women with dense breast tissue. Dense breast tissue presents unique
challenges due to the increased risk of BC and poor visualization
of breast tissue abnormalities, a phenomenon known as masking.
The use of the cheek swab and a significant
uptake across millions of genetic ancestry users has resulted in a
massive increase in interest in Genomics, and in Health Genomics to
achieve affective personal medical outcomes.
2019 represented a tipping
2019 represented a tipping point for the
Genomics industry, with the call from KOLs and industry leaders for
the introduction of Polygenic Risk Score (PRS) into clinic
guidelines. Terms such as “powerful, accurate, better outcomes,
lower mortality, better use of medical resources” are a mantra that
has never before been stated so boldly or so often.
GeneType for BC is well positioned to take
advantage of this change and provides a best in class genomic
solution for the identification of BC risk, as well as better
stratification of risk in the nearly 50% of women who have
heterogeneous or extremely dense breast tissue. With the recent US
federal mandate surrounding breast density notification, GeneType
for BC is positioned to support clinicians in managing patient risk
of developing BC in the context of dense breast tissue.
The company anticipates strong interest in its
test which has been discovered and cross-validated in GWA studies
and large consortia cohorts, respectively. This data includes
hundreds of thousands of women, with and without breast cancer,
underscoring the significance of polygenic risk in the risk
stratification of sporadic breast cancer.
Cost effective and
BC continues to strike at an alarming rate, with
268,000 new invasive and 62,000 non-invasive BC cases projected to
be diagnosed in women in the US in 2019. GeneType for BC is able to
create a cost-effective solution to better identify at-risk women
that are currently being overlooked in the general population.
GeneType for BC will be available at US$249 per
test, and the reduction in the cost (from US$3000 per test in 2011)
and the addition of mammography data is expected to remove a major
hurdle in the adoption and management of risk and BC for women.
The company’s relationship with TGen (The
Translational Genomics Research Institute) in the US is progressing
very well, with the first studies around the best way to implement,
reimburse and distribute GeneType for BC due to commence in Q1
2020. TGen is a trusted independent biomedical institute which is
tasked with the implementation of new Genomic discoveries into the
clinic. Successful studies are expected to result in new commercial
opportunities with major US health networks.
The Company plans to present its latest
technology and world leading tests at the 2020 JP Morgan Healthcare
Conference in January 2020 and will be actively looking to
establish distribution channels to support its market entry
strategy into the US market.
Dr George MuchnickiActing CEO and Justyn Stedwell Company
Secretary On behalf of the Board of DirectorsGenetic Technologies
Limited 7 January 2020
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’s lead products
GeneType for Breast Cancer for non-hereditary breast cancer and
GeneType for Colorectal Cancer are clinically validated risk
assessment tests and are first in class. Genetic Technologies is
developing a pipeline of risk assessment products. For more
information, please visit www.gtglabs.com
Investor Relations and Media (US) Dave Gentry,
CEO RedChip Companies Office: 1 800 RED CHIP (733 2447) Cell: US
407 491 4498 firstname.lastname@example.org
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