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

MELBOURNE, Australia, Jan. 21, 2021 (GLOBE NEWSWIRE) -- Molecular diagnostics company Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”), provides the following 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
    º  Predictive capabilities improved 100% over age and sex alone¹
    º  Analysis confirms that the test is well calibrated²
    º  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 Q1 CY21 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:
    º  BRCA testing to be offered in conjunction with GeneType for Breast Cancer, and
    º  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%³ than disease risk severity based on age and gender alone and the test has been confirmed to be well calibrated⁴.