Molecular diagnostics company Genetic Technologies Ltd (ASX: GTG;
NASDAQ: GENE, “Company”), provides the following update to the
market on the development of the Company’s COVID-19 Severity Risk
Test.
Prototype Development
Genetic Technologies is developing a Polygenic Risk
Score (PRS) test for COVID-19, which may enable an assessment of
risk of an individual developing a serious disease should they
contract the COVID-19 virus. The test is intended to predict
‘disease severity’ using a combination of genetic and clinical
information.
- First successful working prototype developed on a data sample
of approximately 3,000 patients
- Options for clinical risk model currently being evaluated
- The Company is in discussions with several international
biobanks and clinical laboratories to source an independent
cross-validation dataset
The Company has established strong relationships
with international biobanks that enable them to secure additional,
current COVID-19 patient data to continuously refine the COVID-19
Severity Risk Test. This data is crucial to the completion of the
development and validation of the COVID-19 Severity Risk Test.
Implementation
Genetic Technologies has commenced ordering its
first SNP array panel from US-based Thermo Fisher Scientific, the
world leader in genetic testing and Genetic Technologies’
manufacturing partner for GeneType products. The SNP array panel is
a key reagent that is required to process the polygenic risk test
portion of the COVID-19 Severity Risk Test, which is intended to
categorize individuals as being of high, average or low risk of
developing life-threatening conditions due to COVID-19.
“We see ourselves playing a very important part in
responding to COVID-19 and we’re moving quickly to mobilise our
partners to develop the right tools and technology to manage this
pandemic,” said Genetic Technologies Chief Executive Officer Dr
George Muchnicki. “We believe that the COVID-19 Severity Risk Test
has the potential to play a critical role in how companies,
governments and entire countries understand and manage preventative
protocols moving forward.”
Furthermore, Genetic Technologies has confirmed
capacity to scale up production for a global-roll out of the
COVID-19 Severity Risk Test (reagent and SNP array panel) with
major manufacturers, including Thermo Fisher Scientific. The
product uses technical components that are already being produced
by healthcare manufacturers for other genetic-based tests, which
will support the Company’s plans to accelerate production to meet
anticipated global demand. Genetic Technologies’ Australian
facilities will have the capacity of producing up to 250,000 tests
per year. The scale-up of manufacturing will require global
distribution partnerships if COVID-19 Severity Risk Test is widely
adopted.
In anticipation of high demand, Genetic Technology
expects to make its data pack for the COVID-19 Severity Risk Test
available to global labs.
Regulatory Approval
Discussions held with Centres for Medicare and
Medicaid Services (CMS) and National Association of Testing
Authorities, Australia (“NATA”) for regulatory Approval for
COVID-19 Severity Risk Test in the United States and Australia.
- A complete technical package will be submitted to the Centres
for Medicare and Medicaid Services (CMS) for review and
approval
- Clinical Laboratory Improvement Amendments (CLIA) turn-around
time for approval expected to be approximately 45 days from
submission
- The submission of the technical file to include scientific
literature, algorithm validation, lab wet-work validation and
laboratory procedural documentation
- NATA assessment to be provided upon internal review of final
independent data set for test validation
Intended Use
“The COVID-19 Severity Risk Test can play a
critical role for many healthcare systems as they work through
their pandemic management plans over the next year,” said Dr
Muchnicki.
“We expect that the COVID-19 Severity Risk Test,
once fully developed and distributed, will ultimately support
public health initiatives globally and that all countries will
benefit from deploying the test.”
The test is intended to provide risk stratification
information which may help personal and population management in
two ways:
- Providing risk stratification to guide quarantine measures on a
personal, local, and national scale
- Providing risk stratification to prioritize vaccination if and
when a vaccine becomes available
“While scientists move forward with developing a
vaccine for coronavirus, the COVID-19 Severity Risk Test is
intended to empower individuals, their employers and governments by
identifying personalized preventative protocols for each person as
they navigate shifting restrictions and best public health
practices,” said Dr Muchnicki.
“If and when a vaccine is created, governments will
benefit from having a strong understanding of risk stratification
for COVID-19 in their populations to assist with resourcing. There
will be a category of people who are at high risk of
life-threatening complications should they contract the virus. If
they are identified beforehand, those most at risk can be
prioritized to receive the vaccine.”
Intellectual Property
Genetic Technologies has filed a provisional patent
for its COVID-19 Severity Risk Test with IP Australia (2020901739 –
Methods of assessing risk developing a severe response to
Coronavirus infection). The provisional patent covers the specific
SNP (Single Nucleotide Polymorphism) algorithm designed by the
Company to calculate a PRS and the testing model that combines PRS
and the clinical risk factors that together constitute the COVID-19
Severity Risk Test.
“The Company holds an existing patent for the
GeneType platform (polygenic risk test and clinical risk factors)
that is the base of two genetic testing products already available
in the USA and Australia,” said Dr Muchnicki. “The COVID-19
Severity Risk Test uses the same platform, which gives the Company
confidence that the test contained in the provisional patent for
the COVID-19-specific model will be successful.”
Dr George Muchnicki, Acting CEO; and Justyn
Stedwell, Company SecretaryOn behalf of the Board of
DirectorsGenetic Technologies Ltd+61 3 9412 7000
Investor Relations and
Media: (USA)Dave Gentry, CEORedChip
CompaniesOffice: 1 800 RED CHIP (733 2447)Cell: US 407 491
4498dave@redchip.com
(AUSTRALIA)Trevor ChappellWE
CommunicationsEmail: tchappell@we-worldwide.comT: +61 407 933
437
About Genetic Technologies
Limited
Genetic Technologies Limited (ASX: GTG; Nasdaq:
GENE) is a diversified molecular diagnostics company. GTG offers
cancer preventative 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 has capacity for COVID-19
testing and is developing a pipeline of risk assessment
products.
For more information, please visit
www.gtglabs.com.
Forward-Looking Statements
This press release may contain forward-looking
statements about the Company’s expectations, beliefs or intentions
regarding, among other things, statements regarding the expected
use of proceeds. In addition, from time to time, the Company or its
representatives have made or may make forward-looking statements,
orally or in writing. Forward-looking statements can be identified
by the use of forward-looking words such as “believe,” “expect,”
“intend,” “plan,” “may,” “should” or “anticipate” or their
negatives or other variations of these words or other comparable
words or by the fact that these statements do not relate strictly
to historical or current matters. These forward-looking statements
may be included in, but are not limited to, various filings made by
the Company with the U.S. Securities and Exchange Commission, press
releases or oral statements made by or with the approval of one of
the Company’s authorized executive officers. Forward-looking
statements relate to anticipated or expected events, activities,
trends or results as of the date they are made. Because
forward-looking statements relate to matters that have not yet
occurred, these statements are inherently subject to risks and
uncertainties that could cause the Company’s actual results to
differ materially from any future results expressed or implied by
the forward-looking statements. Many factors could cause the
Company’s actual activities or results to differ materially from
the activities and results anticipated in such forward-looking
statements as detailed in the Company’s filings with the Securities
and Exchange Commission and in its periodic filings in Australia
and the risks and risk factors included therein. In addition, the
Company operates in an industry sector where securities values are
highly volatile and may be influenced by economic and other factors
beyond its control. The Company does not undertake any obligation
to publicly update these forward-looking statements, whether as a
result of new information, future events or otherwise, except as
required by law.
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