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 Severity Risk Test.

Prototype Development

Genetic Technologies 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 COVID-19 virus. The test is intended to predict ‘disease severity’ using a combination of genetic and clinical information.

  • First successful working prototype developed on a data sample of approximately 3,000 patients
  • Options for clinical risk model currently being evaluated
  • The Company is in discussions with several international biobanks and clinical laboratories to source an independent cross-validation dataset

The Company has established strong relationships with international biobanks that enable them to secure additional, current COVID-19 patient data to continuously refine the COVID-19 Severity Risk Test. This data is crucial to the completion of the development and validation of the COVID-19 Severity Risk Test.

Implementation

Genetic Technologies has commenced ordering its first SNP array panel from US-based Thermo Fisher Scientific, the world leader in genetic testing and Genetic Technologies’ manufacturing partner for GeneType products. The SNP array panel is a key reagent that is required to process the polygenic risk test portion of the COVID-19 Severity Risk Test, which is intended to categorize individuals as being of high, average or low risk of developing life-threatening conditions due to COVID-19.

“We see ourselves playing a very important part in responding to COVID-19 and we’re moving quickly to mobilise our partners to develop the right tools and technology to manage this pandemic,” said Genetic Technologies Chief Executive Officer Dr George Muchnicki. “We believe that the COVID-19 Severity Risk Test has the potential to play a critical role in how companies, governments and entire countries understand and manage preventative protocols moving forward.”

Furthermore, Genetic Technologies has confirmed capacity to scale up production for a global-roll out of the COVID-19 Severity Risk Test (reagent and SNP array panel) with major manufacturers, including Thermo Fisher Scientific. The product uses technical components that are already being produced by healthcare manufacturers for other genetic-based tests, which will support the Company’s plans to accelerate production to meet anticipated global demand. Genetic Technologies’ Australian facilities will have the capacity of producing up to 250,000 tests per year. The scale-up of manufacturing will require global distribution partnerships if COVID-19 Severity Risk Test is widely adopted.

In anticipation of high demand, Genetic Technology expects to make its data pack for the COVID-19 Severity Risk Test available to global labs.

Regulatory Approval

Discussions held with Centres for Medicare and Medicaid Services (CMS) and National Association of Testing Authorities, Australia (“NATA”) for regulatory Approval for COVID-19 Severity Risk Test in the United States and Australia.

  • A complete technical package will be submitted to the Centres for Medicare and Medicaid Services (CMS) for review and approval
  • Clinical Laboratory Improvement Amendments (CLIA) turn-around time for approval expected to be approximately 45 days from submission
  • The submission of the technical file to include scientific literature, algorithm validation, lab wet-work validation and laboratory procedural documentation
  • NATA assessment to be provided upon internal review of final independent data set for test validation

Intended Use

“The COVID-19 Severity Risk Test can play a critical role for many healthcare systems as they work through their pandemic management plans over the next year,” said Dr Muchnicki.

“We expect that the COVID-19 Severity Risk Test, once fully developed and distributed, will ultimately support public health initiatives globally and that all countries will benefit from deploying the 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
  • Providing risk stratification to prioritize vaccination if and when a vaccine becomes available

“While scientists move forward with developing a vaccine for coronavirus, the COVID-19 Severity Risk Test is intended to empower individuals, their employers and governments by identifying personalized preventative protocols for each person as they navigate shifting restrictions and best public health practices,” said Dr Muchnicki.

“If and when a vaccine is created, governments will benefit from having a strong understanding of risk stratification for COVID-19 in their populations to assist with resourcing. There will be a category of people who are at high risk of life-threatening complications should they contract the virus. If they are identified beforehand, those most at risk can be prioritized to receive the vaccine.”

Intellectual Property

Genetic Technologies has filed a provisional patent for its COVID-19 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 (Single Nucleotide Polymorphism) 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 Severity Risk Test.

“The Company holds an existing patent for the GeneType platform (polygenic risk test and clinical risk factors) that is the base of two genetic testing products already available in the USA and Australia,” said Dr Muchnicki. “The COVID-19 Severity Risk Test uses the same platform, which gives the Company confidence that the test contained in the provisional patent for the COVID-19-specific model will be successful.”

Dr George Muchnicki, Acting CEO; and Justyn Stedwell, Company SecretaryOn behalf of the Board of DirectorsGenetic Technologies Ltd+61 3 9412 7000

Investor Relations and Media:  (USA)Dave Gentry, CEORedChip CompaniesOffice: 1 800 RED CHIP (733 2447)Cell: US 407 491 4498dave@redchip.com

(AUSTRALIA)Trevor ChappellWE CommunicationsEmail: tchappell@we-worldwide.comT: +61 407 933 437

About Genetic Technologies Limited

Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE) is a diversified molecular diagnostics company. GTG offers cancer preventative 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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