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Genetic Technologies Provides Update on COVID-19 Disease Severity Test Development

Genetic Technologies Ltd
·7-min read

MELBOURNE, Australia, Sept. 15, 2020 (GLOBE NEWSWIRE) -- 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 Secretary
On behalf of the Board of Directors
Genetic 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

Australia
Trevor Chappell
WE Communications
Email: tchappell@we-worldwide.com
T: +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.