Molecular diagnostics company Genetic Technologies Limited (ASX:
GTG, NASDAQ:GENE) (“Genetic Technologies” or the "Company") 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 virus. The test is intended to
predict ‘disease severity’ using a combination of genetic and
clinical information. The Company is pleased to provide the
following update on the test development program:
- Completed development of a prototype Polygenic Risk Score
- Completed development of a clinical risk model
- Completed evaluation of the combined (clinical + polygenic)
comprehensive risk model
- Sourced cross validation data (expected late September / early
October)
- Filed provisional patent
- Identified potential partner for pilot scale implementation
study and commenced discussions
- Completed preliminary analysis of “Workforce Management by
Polygenetic Testing”
Genetic Technologies utilized existing
relationships with international biobanks and health studies to
secure the requisite patient data to develop its COVID-19 Disease
Severity Risk Test. The Company is extremely pleased with the early
performance characteristics of the prototype test. Crucial to
the completion of the test is a cross validation of the model in an
independent dataset. Although the State of Victoria in Australia
has experienced a significant second wave of COVID-19 cases, the
requisite data is not available locally at this time. To complete
the test development process, the Company has sourced additional
data from Europe that is expected to be available in late September
/ early October.
The Company expects to submit the test
validation studies for publication in the mainstream medical
literature and make the data publicly available at the same
time.
Genetic Technologies has designed and ordered
its first SNP (Single Nucleotide Polymorphism) array panel from
US-based Thermo Fisher Scientific Inc, a world leader in genetic
testing and GTG manufacturing partner for GeneType products. The
first batch of prototype arrays are expected to be delivered to the
Company’s laboratory during the week of September 21, 2020 and will
be used to validate and verify the laboratory process prior to
submission of the test for regulatory approval.
As reported in the Company’s Quarterly
Activities Report on July 29, 2020, the Company has held
discussions to confirm procedural information with the Centres for
Medicare and Medicaid Services (CMS) and National Association of
testing Authorities, Australia (“NATA”) for regulatory Approval for
the COVID-19 Disease Severity Risk Test in the United States and
Australia.
The submission of the technical file (to include
scientific literature, algorithm validation, lab wet-work
validation and laboratory procedural documentation) will be made to
both organisations.
Genetic Technologies has filed a provisional
patent application for its COVID-19 Disease 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 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 Disease
Severity Risk 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; and
- Providing risk stratification to prioritise vaccination if and
when a vaccine becomes available
In preparation for the requirement to
demonstrate supporting clinical utility of our approach, the
Company has commenced a collaborative study to model the impacts on
workforce protection through the use of the COVID-19 severity risk
test.
Employers cannot afford to close every time
infections arise without significant damage to their businesses.
The current modelling studies are designed to provide tailored
workforce policies based on individual employee risk profiles
provided by Genetic Technologies’ COVID-19 Disease Severity Risk
Test.
Genetic Technologies prototype COVID-19 test
combining demographic factors, health indicators and polygenetic
characteristics is able to identify individuals most at risk of
hospitalisation if they are infected with COVID-19. Based on the
characteristics of the prototype test, individuals in the top
decile of polygenetic scores are more than three times as likely to
require hospitalisation as those with average polygenetic
scores.
More accurate identification of individuals at
highest risk could enable employers to tailor return to work and
work at home policies that provide most protection. Modelling work
undertaken by Sam Lovick Consulting using results from the
prototype shows that tailored work from home policies based on the
test, when combined with precautions against infection for
home-based workers, could reduce workforce hospitalisations by
between 20% and 65% (depending upon the proportion of home-based
workers and the extent of infection in the community); a company
with 10,000 employees could potentially reduce hospitalisations by
290 resulting in 10 fewer deaths.
Preliminary discussions have been held with
potential collaborating organizations to test this approach within
a real workplace and will be announced in due course.
On 11 September 2020 GTG announced that initial
sales of its GeneType for Breast Cancer Risk Assessment commenced
in the United States via an online health platform, elicity by
InTeleLabs, an independent telehealth and personalised medicine
company.
The Company will now expand this online sales
capability by making the COVID-19 Disease Severity Risk Test
available to US customers, targeted as a Q4 2020 release.
Dr George Muchnicki Acting CEO and Justyn
Stedwell Company SecretaryOn behalf of the Board of
DirectorsGenetic Technologies Limited+61 3 8412 7000
Investor Relations and Media (US)
Dave Gentry, CEO RedChip Companies Office: 1 800 RED CHIP (733
2447) Cell: US 407 491 4498 dave@redchip.com
AustraliaTrevor ChappellWE
CommunicationsEmail: tchappell@we-worldwide.comT: +61 407 933
43
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
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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