GTG developing a genetic test in the fight against COVID-19

Dual-listed Genetic Technologies (ASX:GTG | NASDAQ: GENE) is fast-tracking development of a genetic test that will determine if people are at a high risk of contracting COVID-19.

The company is to commence accelerating development of a polygenic risk score (PRS) test to predict an individual’s risk of developing life-threatening complications should they become infected with COVID-19.

Knowing a person’s risk of contracting COVID-19 and complications can have a huge impact on the community and the economy, in terms of saving lives, better utilising medical resources, getting people back to work, and ensuring that those who most need protection are protected properly.

The company anticipate approximately a three-month development timeline for the review of data and the potential design of a predictive risk model and would then seek to obtain CLIA and potentially other approvals of the laboratory derived test.

Once developed, Genetic Technologies’ COVID-19 test will have global application. A vaccine for COVID-19 is expected to still be a long while off, so this genetic test will be another bullet in the armoury to fight the virus until a vaccine arrives.

The diversified molecular diagnostics company has already developed similar genetic tests for breast cancer and colorectal cancer. Its 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. It was also involved in the first major study of the human genome.

Genetic Technologies CEO Dr George Muchnicki said "GENE [GTG] has secured a data set of over 1,500 patients who experienced COVID-19 and we intend on leveraging our core expertise in predictive risk modelling, to analyse the early, available genomic and phenotypic data from those COVID-19 patients with a view to developing a comprehensive predictive model to identify those patients most likely to require hospitalisation, should they become infected with the COVID-19 virus."

Dr Richard Allman Chief Scientific Officer said "Our core-strength is in the design and construction of novel risk algorithms for common, complex diseases. We anticipate that the design of a new predictive test will utilise similar concepts to those used in our existing core GeneType risk assessment products.

“We are fast-tracking analysis of the data set we have received and then we are commencing the development process with the aim of having sufficient understanding of that data to develop and validate a prototype test in the shortest time period possible.

“Of course, until we complete that analysis there is no guarantee that the genetic markers we are looking for will provide sufficient statistical evidence to support predictive risk modelling test."

Further to the above, the company provided a market update on 18 May. This included news that a NASDAQ hearing panel granted full extension for continued listing and details of recent Board changes, plus the following updates.

Further validation of the GeneType for breast cancer and colorectal cancer tests

Two R&D studies are nearing completion which provide further important validation data supporting the GeneType for breast and colorectal cancer tests.

The results are expected to be submitted for publication in peer-reviewed medical journals in the next quarter. The content of these publications is crucial in driving physician acceptance of our tests.

Importantly, the analyses which are derived from large-scale cohort data, include prospective data analysis and set the stage for progressing our plans to develop clinical utility evidence in support of our reimbursement strategy.

Type-2 Diabetes test progressing

In further positive progress, the company has completed development of a prototype test for Type-2 Diabetes. The Melbourne laboratory is implementing the internal work flows and verification procedures prior to commercial launch.

The test is designed to incorporate a polygenic risk score in combination with a clinical risk algorithm to better predict the risk of developing Type-2 Diabetes.

Consumer Initiated Testing (CIT) platform Agreement Signed

After an extensive search and review the company has signed with its preferred CIT platform provider to enable sales of tests to be initiated directly by consumers in the United States.

The company’s current CLIA and NATA accredited laboratory will be utilised for the provision of tests across its current GeneType for Breast and GeneType for Colo-Rectal cancer and will have the capacity to provide additional tests as they come to market. The Platform is expected to go live within 60 days.