The test uses a polygenic risk score (PRS) to predict an individual’s risk of developing life-threatening complications should they become infected with COVID-19.
Genetic Technologies CEO Dr George Muchnicki said: "GENE 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 hospitalization, should they become infected with the COVID-19 virus."
Predictive test design
Genetic Technologies chief scientific officer Dr Richard Allman 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."
The polygenic risk score (PRS) predicts an individual’s risk of developing life-threatening complications if they contract COVID-19
Dr Muchnicki said: "We anticipate approximately 3-month development timeline for the review of that data and the potential design of a predictive risk model and then we would need to obtain Clinical Laboratory Improvement Amendments (CLIA) and potentially other approvals of the laboratory-derived test."
Once developed, the test will have global application, however, the company acknowledges that 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 and that if COVID-19 is effectively contained (or the risk of infection is materially diminished or eliminated) there may be no demand for the tests.
Validation of GeneType product
Two research and development studies are nearing completion for Genetic Technologies GeneType test for breast and colorectal cancer tests.
The results are expected to be submitted for publication in peer-reviewed medical journals in the next quarter and set the stage to progress the company’s plans to develop clinical utility evidence as well as driving physician acceptance of the tests.
The company has also completed development of a prototype test designed to incorporate a polygenic risk score in combination with a clinical risk algorithm to better predict the risk of developing Type-2 Diabetes.
The Melbourne laboratory is currently implementing the internal workflows and verification procedures prior to commercial launch.
The company's breast and colorectal cancer products are market ready
CIT platform agreement signed
Genetic Technologies has signed with its preferred Consumer Initiated Testing (CIT) platform provider to enable sales of tests to be initiated directly by consumers in the United States.
The company’s current CLIA and National Association of Testing Authorities (NATA) accredited laboratory will be utilised for the provision of tests across 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.
Board and management changes
The board has confirmed that Dr Jerzy Muchnicki will maintain his current position as interim CEO and current director Peter Rubinstein will assume the role of chairman.
GTG also welcomes a new chief operating officer in Stan Sack, who has spent 15 years in large listed entities in executive positions managing large business divisions.