Genetic Technologies Announces New Partnership and geneType COVID-19 Risk Test Patent Allowance from the USPTO

MELBOURNE, Australia, Dec. 09, 2021 (GLOBE NEWSWIRE) -- Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”, “GENE”), a global leader in genomics-based tests in health, wellness and serious disease confirms that the Company’s US patent application for its novel geneType COVID-19 Risk Test has been accepted:

• New partnership agreement signed with IBX and 1health expands patient access in US
• Patent accepted by United States Patent and Trademark Office (“USPTO”) for the geneType COVID-19 Risk Test
• Cross validation of the geneType COVID-19 Risk Test completed in an independent cohort confirms test performance
• Spread of new and emerging variants including Omicron highlight the importance of understanding the risk of developing serious symptoms

GENE confirms our patent attorneys received a USPTO Notice of Allowance on December 8, 2021, in connection with the referenced application. Formalities will be reviewed and a formal report provided within the next 10 days which will include the US patent number for the Granted Patent.

The Company is also pleased to announce a new partnership to expand access to the COVID-19 Risk Test in the US through GENE’s agreement with IBX and 1health on their ‘Vitagene’ platform directly from https://genetype.com/for-individuals/COVID-19/. 1health is a leading US-based cloud platform service provider for diagnostic test management. 1health has built infrastructure that helps laboratories, such as IBX and their customers, connect patients to testing and care. 1health’s services will be managed in partnership with IBX under our three-year co-exclusive licence agreement announced on March 3, 2021.

GENE has continued to expand and develop the geneType COVID-19 Risk Test, having recently completed a cross-validation study on a European data set confirming the test performance metrics. A paper describing the study has now been submitted to a peer-reviewed journal and will be released upon publication. The emergence of the Omicron variant underscores the importance of being able to identify those patients, whether vaccinated or not, who are at greater risk of developing severe disease.

GENE’s CEO, Simon Morriss, noted, “The geneType COVID-19 Risk Test is now available through our US partners, IBX and 1Health, and customers should consider this as an optional ‘add on’ request for a COVID-19 polymerase chain reaction (PCR) test. Genomics is commonly used to determine the various COVID strains and origins but here at GENE we are harnessing the power of genomics to manage the risk of serious disease. This will greatly enhance the understanding of the disease status of patients and equip them with actionable insight to understand their individual risk. There remains a significant market for COVID-19 PCR tests in the US with over 900,000 tests performed daily in early December 2021¹.”

The geneType COVID-19 Risk Test is designed to predict disease severity in people aged 18 and older, using genetic and clinical information providing a risk score that can be used to understand a person’s risk of contracting a serious case of COVID-19. In addition, employers, governments, and other public health entities may use the data to make informed decisions about disease risk, treatment options, and importantly guiding vaccination and booster priorities. According to the Centers for Disease Control and Prevention, only 71.2% of the US population is fully vaccinated leaving approximately 95 million Americans unvaccinated. The geneType COVID-19 Risk Test could assist these people to better understand their risk of severe disease, while providing those who are vaccinated (approximately 235 million people) with an incentive to obtain a booster if they are at high risk of severe disease.

Authorised for release by the Board of Genetic Technologies Limited

About Genetic Technologies Limited
Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”, “GENE”) is a diversified molecular diagnostics company. GENE 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 including its multi test covering over 70% of the most prevalent mortalities and morbidities. For more information, please visit www.genetype.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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¹ https://ourworldindata.org/grapher/covid-19-daily-tests-vs-daily-new-confirmed-cases?tab=table&country=BHS~CAN~JAM~MEX~PAN~KNA~VCT