Genetic Technologies Provides Operational Update - Successful Prototype Polygenic Risk Score for COVID-19 Created
May 22 2020 - 04:05PM
Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE) (the
“Company”) provides the following operational updates:
- Normal commercial operations will
recommence from 1 June 2020
- Confirmed that a prototype
polygenic risk score can successfully discriminate between COVID-19
patients who required hospitalization from those who did not
require hospitalization
- Continued discussions with third
parties around use of existing CLIA and NATA accredited laboratory
for performance of COVID-19 testing
Normal commercial operations will recommence
from 1 June 2020 following confirmation that the Company can resume
importation of samples from the USA. To accompany that process, the
Company will be working with its Consumer Initiated Testing (CIT)
platform supplier to generate online product content to support
sales activities in the USA.
Leveraging Genetic Technologies’ core expertise
in predictive risk modelling, the Company has also now completed
analysis of the early, available genomic and phenotypic data from
1,500 COVID-19 patients. From this data, the Company has developed
a first “proof of concept” analysis, which has confirmed that a
prototype polygenic risk score successfully discriminated between
those COVID-19 patients who required hospitalization from those who
did not require hospitalization.
The next stage in the product development
process will be to confirm and improve upon the initial
observations as more patient data becomes available. On completion
of that review of the additional patient data (anticipated over the
next 30 days), the Company intends to seek CLIA registration of the
product as a new polygenic risk score (PRS) test to predict an
individual’s risk of developing life-threatening complications
should they become infected with COVID-19.
CEO of Genetic Technologies Dr George Muchnicki
commented, "We are now confident that a person's reaction to
catching COVID-19 and their risk of hospitalisation is also
affected by their genes rather than just their age. We have a
strong model that will be the basis of a useful test, which can be
used to stratify an individual's risk and may even assist in
supporting natural herd immunity."
“As more data becomes available in the coming
weeks, we plan to further strengthen the model,” added Dr Richard
Allman, Chief Scientific Officer of Genetic Technologies. “The
results from the initial prototype analysis are very encouraging,
and our team is now focused on rapidly executing ongoing
development efforts that we hope will ultimately bring this
much-needed test to market.”
The Company notes that it continues to have
discussions with third parties around use of its existing CLIA and
NATA accredited laboratory for performance of COVID-19 testing and
will provide updates as developments progress on both PRS models
for COVID-19 and COVID-19 testing.
About new predictive risk
modelling
Development of a new predictive COVID-19 test
carries substantial risks and there is no guarantee that GENE will
be able to successfully produce a test that allows for the
assessment of predictive risk in a timely manner, if at all.
Additionally, an effective test depends upon the ability to rapidly
produce the test results. Further if COVID-19 is effectively
contained or the risk of infection is materially diminished or
eliminated - there may be no demand for a predictive modelling of
COVID-19. Please note that a commercial COVID-19 predictive test is
subject to regulation in the USA by CLIA and other domestic and
international governmental, public health agencies, regulatory
bodies or non-governmental organizations. The process of obtaining
required approvals or clearances for a potential new product varies
according to the nature of and uses for a specific product.
About Genetic Technologies
Limited
Genetic Technologies Limited is a diversified
molecular diagnostics company which 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.
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.
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
Genetic Technologies (NASDAQ:GENE)
Historical Stock Chart
From Feb 2024 to Mar 2024
Genetic Technologies (NASDAQ:GENE)
Historical Stock Chart
From Mar 2023 to Mar 2024