Genetic Technologies Provides Update on its COVID-19 Disease Severity Risk Test and Expansion into Germline Testing - Seite 2

Further datasets are expected to be made available over the coming months and will be included in the platform to continue to enhance the predictive capabilities of the algorithm but will not impact on the current regulatory submission to CMS/CLIA by the end of Q1 CY21. These datasets will also enable further cross-validation and scientific publications based on the increased data and anticipated expansion of age assessment capabilities.

Laboratory Implementation
Laboratory reagents for performing the test commercially have been designed and are currently being validated in preparation for regulatory submission to CMS/CLIA with a view to targeting sales in the USA initially. The test is being validated as a multi-platform test, including as a Next Generation Sequencing Test, Mass array test with further platforms in development, to mitigate supply chain risk associated with the required reagents allowing for a de-risked commercialization pathway. This is also expected to provide greater flexibility for potential distribution partners. The laboratory reagents are being independently cross validated at the Australian Genome Research facility (AGRF).

Planned Commercialization
First-stage commercial distribution is intended to focus on engagement with key distributors in the US. The COVID-19 test was originally conceived as a personal and population-based risk management tool. Additional applications, now evident, may enable the ability to provide a test to assist in the prioritization of who will receive the vaccine first given the supply constraints and time for widespread access and a risk assessment tool for individuals given the rapid introduction of vaccines. The Company also anticipates that the knowledge gained may provide valuable insight for the development of a broadly applicable infectious-disease susceptibility model in the future.

Germline Testing Division
Expanding the scope of the GeneType Tests

As previously outlined, Genetic Technologies established the Germline Testing division following the strategic decision to offer hereditary testing for inherited cancer. The initial product focus for the division will be on BRCA testing to align with the Company’s GeneType for Breast Cancer product and Lynch Syndrome testing to align with the Company’s GeneType for Colorectal Cancer. This approach provides several strategic benefits, being the ability to identify cancer risk across the whole spectrum of cancer causation, from hereditary cancers caused by monogenic mutations to sporadic cancers with a polygenic, multifactorial cause.