GENE Genetic Technologies Ltd

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 Risk Test.

Key highlights

• New findings submitted to peer-reviewed journal and medRxiv on GTG’s predictive model outlined in the technical paper, ‘An integrated clinical and genetic model for predicting risk of severe COVID-19’
• Findings include:° Model accuracy predictions of severe COVID-19 with a 111% better discrimination of the disease severity than age and gender alone ° Leveraged over 1,500 UK Biobank participants aged over 50 with clinically confirmed COVID-19
• Submission of amended patent to incorporate additional findings on genetic risk stratification

Genetic Technologies has outlined additional findings in relation to its COVID-19 Risk Test. The COVID-19 Risk Test model incorporating the single-nucleotide polymorphism (SNP) score and clinical risk factors was applied to the UK Biobank data consisting of data on over 1,500 individuals over the age of 50 with clinically confirmed COVID-19. The findings from the model included a 111% better discrimination of the disease severity than age and gender alone. These results further highlight that continuing to rely on age and gender to determine risk of severe COVID-19 may unnecessarily classify healthy older people as being at high risk and will fail to accurately quantify the increased risk for younger people with comorbidities.

Further details on the performance characteristics of the test and description of the underlying research are outlined in the technical paper submitted to the preprint server for Health Sciences, medRxiv and have also been submitted for peer-review. Available here: https://www.medrxiv.org/content/10.1101/2020.09.30.20204453v1.full.pdf

Richard Allman, Genetic Technologies’ Chief Scientific Officer said: “As we move to reopen our economy across Australia it is critical that we are able to undertake this process as safely as possible. The ability to assess the risk in the general population to develop a severe case of COVID-19 by genetic risk factors in contrast to age alone would have the potential to enable the economy to return to normal more rapidly by empowering individuals to make informed decisions on their risk profile.”

GTG’s risk prediction test for severe COVID-19 in people aged 50 years or older has great potential for wide-reaching benefits in managing the risk for essential workers, in healthcare settings and in workplaces that seek to re-open safely. The test will also enable individuals to make informed choices based on their personal risk. However, key to understanding the performance of our risk prediction test will be validation in independent data sets, work that GTG intend to undertake in the near term.

Patent UpdateGTG has submitted an update to the previously filed provisional patent for its COVID-19 Risk Severity Test with IP Australia (2020901739 – Methods of assessing risk developing a severe response to Coronavirus infection) as submitted on 27 May 2020. The amendments were filed on 30 September 2020 and incorporated GTG’s latest findings as outlined in the technical paper.

The provisional patent covers the specific SNP algorithm designed by GTG to calculate the Polygenic Risk Severity (PRS) and the testing model that combines the PRS test and the clinical risk factors that together constitute the COVID-19 Risk Test.

Background on GTG’s PRS test for COVID-19Genetic Technologies is developing a PRS test for COVID-19, which may enable the risk assessment 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.

The test is intended to provide risk stratification information which may help personal and population management in two ways:

• Guiding quarantine measures on a personal, local, and national scale
• Prioritising vaccination if and when a vaccine becomes available

Further updates will be provided to the market as the Company progresses product validation.

Released on behalf of the Board of Directors Genetic Technologies Limited.

Investor Relations (AUS)	Investor Relations and Media (US)
Stephanie Ottens	Mr Dave Gentry RedChip Office:
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E: stephanie.ottens@marketeye.com.au	E: dave@redchip.com

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