Genetic Technologies Provides Operational Update - Successful Prototype Polygenic Risk Score for COVID-19 Created

MELBOURNE, Australia, May 22, 2020 (GLOBE NEWSWIRE) -- 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.

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