GENE Embarks on Breakthrough African American Collaboration for Breast Cancer as Part of Its Commitment to Ethnic Diversity

Study to focus on women of African American descent for expanded polygenic risk test

MELBOURNE, Australia, Sept. 28, 2021 (GLOBE NEWSWIRE) — Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”, “GTG”), a diversified Genomics and AI driven preventative health business today announced that they have entered into a strategic collaboration with the Institute of Public Health in St Louis USA for the purpose of expanding the predictive capabilities of the GeneType for Breast Cancer product to include women of African descent.

Highlights:

• GENE self-funding collaborative study to enable expanded risk testing for populations of African descent as part of our commitment to ethnic diversity
• Addressing underlying and underserved need to include diverse population studies within risk testing protocols and applications
• Designed to enable identification of high-risk individuals with benefit and application for the 47 million individuals of African descent residing in the United States
• In line with strategic objective to invest to expand testing to provide inclusive polygenic risk scores for multi-ethnic populations
• Study will be in collaboration with Professor Graham Colditz, a world-renowned figure in breast cancer epidemiology and risk modelling on women of African American descent

Genetic Technologies have committed to fully fund a collaborative study with Professor Graham Colditz, Deputy Director of the Institute for Public Health. The purpose of the study is to incorporate further research and data on women of African descent to provide expanded testing capabilities for the GeneType for Breast Cancer product. There exists a significant unmet need for polygenic risk testing for ethnically diverse populations where risks of mortality from Breast Cancer is estimated to be 40% higher in African American women than Caucasian women¹. Polygenic risk models are required to be validated for use with multiple ethnicities and therefore GENE will be validating samples which have both genotype information and the relevant clinical information to cover this expanded population.

This investment will be self-funded by GENE with costs partially offset by an R&D tax rebate estimated to be 43.5% of the costs associated with the study which is expected to contribute ~1,000 samples. The collaboration is anticipated to require around 9 months of research and processing at GTG’s Melbourne Laboratory.

Commenting on the study, CEO Simon Morriss stated: “Expanding our capabilities to include those of African descent is a critical element of our long-term strategy. To fully address the growing burden of common complex diseases on our healthcare systems we need to be able to provide predictive risk tests for all individuals to empower them with the information to proactively manage their health and understand their risk. This is the first step in our response to address the unmet demand for tests that have been validated on multi population datasets. We will continue to assess our product portfolio to ensure we are expanding our addressable population and providing inclusive polygenic risk scores for multi-ethnic populations.”

Professor Colditz is a world-renowned figure in breast cancer epidemiology and risk modelling, with notable genotype datasets on the African American population held by the Institute for Public Health. Given the multi-ethnic landscape (particularly in the USA) in which risk models may be used in clinical practice, it is important to understand how the risk model performs in these populations. The lifetime probability of developing non-hereditary breast cancer is 11.5% (1 in 9) for the African American population in the USA¹.

Dr Richard Allman, GTG’s Chief Scientific Officer, will be heading the initiative and stated, “Our aim is to develop the best practical risk assessment tool for breast cancer. We hypothesise that a risk prediction model that is easy to answer while containing important risk-predicting information such as a polygenic risk score, a mammographic density risk score, and an absolute-risk, based on family history and selected clinical risk factors will provide better risk discrimination than any of the currently available individual risk models that do not incorporate all of these risk factors.”

This study demonstrates Genetic Technologies commitment to provide risk tests for whole populations to provide proactive predictive risk assessments. GENE have made significant advancements in its products and continues to invest in further research and development of both existing and future products. The Company continues to advance its strategic objective to provide the most comprehensive preventative risk tests for common complex disease.

Authorised for release by the Board of Genetic Technologies Limited

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

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.

^{_____________________________
1} American Cancer Society: Cancer Facts & Figures for African Americans 2019-2021