Genetic Technologies (ASX: GTG) has entered into an agreement with US-based Translational Genomics Research Institute (TGen) to develop and commercialise a suite of polygenic risks tests for the American market.
While exact terms of the agreement are confidential, the companies disclosed today that they would work together to establish fundraising mechanisms needed to achieve the commercialisation strategy and infrastructure development.
The latter will include the priority establishment of a co-managed Clinical Laboratory Improvement Amendments (or CLIA) lab and provision of the polygenic test portfolio to a major US health provider.
CLIA regulations were introduced to the US in 1988 to regulate the standards for laboratory testing performed on specimens from humans for the purpose of diagnosis, prevention, or treatment of disease or assessment of health.
The US-based lab will offer Genetic Technologies’ existing and future tests including oncology polygenic risk tests for melanomas as well as breast, colorectal and prostate cancers.
Non-oncology tests will also be offered for cardiovascular disease and diabetes.
Speed to market
Genetic Technologies is developing and commercialising a suite of clinically-validated genetic risk assessment (or polygenic) products aimed at preventing morbidity and mortality across a range of life-threatening diseases.
The company partners with world-leading research hospitals to develop the clinical use of polygenic risk scores in treatment decisions.
“Speed to market” is critical in the genomics field and Genetic Technologies’ established network of academic collaborators in Australia and the US is positioned to rapidly accelerate the clinical validation process and introduce new products to market.
Arizona-based TGen specialises in unravelling the genetic components of common and complex diseases including cancer, neurological conditions and rare childhood disorders.
The research group is affiliated with California’s City of Hope medical centre – a world-renowned independent research and treatment centre for cancer, diabetes and other serious diseases.
Polygenic tests could well be the future of predictive medicine, promoting a focus on disease risk identification coupled with medically-supervised, patient-focused preventative actions.
Genetic Technologies’ first-to-market genetic risk test for colon cancer is scheduled to be commercialised later this year.
Colon and colorectal cancers are a leading cause of cancer death and disability in Australia and the US.
In 2018, they represented 12.3% of all new cancers diagnosed in Australia.
At midday, shares in Genetic Technologies were steady at $0.007.