Genetic Technologies Limited provides the update to the market on further development on the COVID-19 serious disease risk Polygenic Risk Score Test (COVID-19 PRS Test) and expansion of the Company’s offering to include Germline Testing division. Key Highlights: Total COVID-19 positive patient data analyzed exceeds 5,500 following inclusion of further 4,000 patients’ data, Predictive capabilities improved 100% over age and sex alone, Analysis confirms that the test is well calibrated, Further datasets will continue to enhance the accuracy and consistency of the algorithm, Anticipate submission for regulatory clearance via Centers for Medicare and Medicaid Services/Clinical Laboratory Improvement Amendments (CMS/CLIA) by the end of first quarter of fiscal 2021 following final validation process of expanded dataset, In active conversations on commercialization opportunities in conjunction with CLIA regulatory submission and clearance, Additionally, as previously announced, the Company has commenced with equipment calibration along with specialized inhouse training of the scientific team to establish the Germline Testing division for hereditary cancer risk with initial focus on: BRCA testing to be offered in conjunction with GeneType for Breast Cancer, and Lynch Syndrome testing to be offered in conjunction with GeneType for Colorectal Cancer COVID-19 PRS Test. Product Advancements Leveraging Genetic Technologies’ core expertise in predictive risk modelling, the Company utilized the initial dataset of 1,500 patients known to have a positive COVID-19 diagnosis from the UK biobank to develop a comprehensive predictive model to identify those patients most likely to require hospitalization should they become infected with the COVID-19 virus. The UK biobank released a further dataset on COVID-19 positive patients consisting of ~4,000 confirmed COVID-19 infected patients in November 2020. Following further assessment the Company utilized this data to further update and validate the COVID-19 PRS Test. This has resulted in enhanced validation of the predictive capabilities of over 100% than disease risk severity based on age and gender alone and the test has been confirmed to be well calibrated. 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 First Quarter 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 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). 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.