Genetic Technologies Continues to Break New Ground as it Advances Development of its Predictive Risk Test for Multiple Cancers & Morbidities

Rhea-AI Summary

Genetic Technologies Limited (NASDAQ: GENE) announced progress on its Predictive Panel Risk Test, designed to assess risks for six common cancers, accounting for approximately 70% of annual morbidity. Patent-backed innovations enhance predictive capabilities, particularly in prostate and melanoma testing. The test aims for flexibility in risk assessment, combining hereditary cancer genes and polygenic risks. Future iterations will expand to include cardiovascular disease and Type 2 diabetes. The rollout strategy targets reimbursable cancers in Australia and the U.S., potentially affecting 30% of annual mortality rates.

Positive

• The Predictive Panel Risk Test targets six cancers, covering ~70% of annual morbidity.
• Advancements in prostate cancer and melanoma tests may improve predictive accuracy.
• New device approved by TGA, FDA, and European authorities for multiple jurisdictions.
• Integration of cardiovascular disease and Type 2 diabetes testing in future iterations.

Negative

• None.

MELBOURNE, Australia, July 09, 2021 (GLOBE NEWSWIRE) -- Genetic Technologies Limited (ASX: GTG, NASDAQ: GENE, "Company", "GTG"), a diversified Genomics and AI driven preventative health business, today announced updates on the development of its Predictive Panel Risk Test designed to cover six different cancers including breast and colorectal cancer, prostate and ovarian cancer, pancreatic cancer and melanoma.

Key Highlights:

• Predictive Panel Risk Test to cover six common cancers which account for ~70% of annual morbidities.
• Leverages foundational IP – Methods for Genetic Analysis (US Patent 7,127,355)
• New advances in Prostate Cancer and Melanoma tests may enhance predictive capabilities
• Integrates cardiovascular disease, Type 2 diabetes, and germline testing in future iterations of the test
• The new device that will accompany this test has been designed and approved by the TGA, FDA and Europe for use in multiple jurisdictions
• In discussion with Global distribution partners

“We have made notable progress on our Predictive Risk Test with advancements across a number of the included disease panels, providing improvements in the predictive accuracy of our product, stated Simon Morriss, CEO of Genetic Technologies. “Our panel test has been designed with the end physician and patient in mind with a strong focus from the outset on a clear path to commercialization. We are extremely encouraged by the strong progress we have seen over the past few months, and with clarity on our roll out strategy, we are confident we can generate significant interest in the test.”

Predictive Risk Test Update

The Predictive Risk Test combines clinical patient information with genetic information to maximize test accuracy, leveraging the Company’s foundational IP (US Patent 7,127,355 Methods for Genetic Analysis) to enable the best health risk assessment test available.

Recent advances in our prostate cancer and melanoma tests have identified informative polygenic risk scores that could enhance predictability with the Company intending to release the results by the end of the calendar year. The polygenic risk components of the breast cancer and colorectal cancer GeneType tests have also been improved via updated genetic risk factors.

Genetic Technologies plans to incorporate new clinical risk models into the polygenic tests which are currently under development and undergoing validation in large-scale cohort studies. Polygenic risk scores for ovarian cancer and pancreatic cancer are in late stage development with product launch scheduled for this current calendar year.

The Predictive Risk Test is designed to offer maximum flexibility for physicians administering the test. It will allow for a targeted risk assessment of single diseases with combined assessment of hereditary cancer genes and polygenic risk or can allow for a broader “multi-test” risk assessment to provide risk profiling across multiple disease types simultaneously.

Predictive Risk Test Strategy

The overall strategy for the Company’s Predictive Risk Test is focused on precise risk assessments for the most common preventable diseases. Future iterations of the test will include cardiovascular diseases and Type 2 diabetes along with the Company’s germline hereditary cancer testing products which are currently under development. The addition of the germline hereditary testing panel will be incorporated into the GeneType Predictive Risk Test this year.

When test development is completed, in addition to polygenic and clinical risk, physicians and patients will have their complete risk available for the leading cancer, cardiovascular and diabetes outcomes.

Program rollout is focused on major cancers which are reimbursable for germline testing, both in Australia and the US. With the addition of cardiovascular disease and Type 2 diabetes, the test will cover up to 70% of chronic disease morbidity, with the potential to have a significant impact on patients and physicians through targeted screening and disease prevention to allow for behavior modification and early prophylactic interventions. As a group, the diseases covered by the Predictive Risk Test account for approximately 30% of annual mortality.

Investor Relations (AUS)	Investor Relations and Media (US)
Stephanie Ottens	Dave Gentry
Market Eye	1 800 RED CHIP (733 2447)
M: +61 434 405 400	Cell: 407 491 4498
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 

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.

FAQ

What recent updates did Genetic Technologies Limited (GENE) announce regarding their Predictive Panel Risk Test?

Genetic Technologies Limited announced advancements in their Predictive Panel Risk Test for assessing risks for six common cancers, with plans to integrate more diseases in future iterations.

How does the Predictive Panel Risk Test from Genetic Technologies Limited work?

The test combines clinical patient information with genetic data to maximize accuracy in risk assessments for hereditary cancers and polygenic risks.

When is the product launch for Genetic Technologies Limited's ovarian and pancreatic cancer tests scheduled?

The product launch for ovarian and pancreatic cancer tests is set for the current calendar year.

What is the expected impact of the Predictive Panel Risk Test on disease prevention?

The test is expected to significantly impact disease prevention strategies, potentially allowing for early interventions in targeted diseases accounting for 30% of annual mortality.

What regulatory approvals has the new device for the Predictive Risk Test received?

The new device has been approved by TGA, FDA, and European authorities, allowing its use in multiple jurisdictions.