Benzinga | Jul 9, 2021 08:39AM EDT

UPDATE: Genetic Technologies Offers 6 Key Highlights Related To Development Of Its Predictive Risk Test for Multiple Cancers, Morbidities

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.