Benzinga | Apr 26, 2021 05:28AM EDT

Genetic Technologies Announced its Covid- 19 Risk Test Approved for Commercial Release; Commercial Release Is Expected to Occur No Later Than the End of May

: Genetic Technologies Limited (NASDAQ:GENE) "Company", "GTG"), a diversified Genomics and AI driven preventative health business provides an update to the market on the progress of the US commercial availability of the Company's COVID-19 Serious Disease Risk Test (COVID-19 Risk Test') via US Based Infinity BiologiX LLC (IBX'), (ref: ASXAnnouncement 3 March 2021). The Company confirms the submission of the COVID-19 Risk Test regulatory pack to the regulators1 In conjunction with prior correspondence with the regulators this submission enables the commercial release within the United States Final steps in the technical interface are being built with additional capabilities for the telehealth platform to enable sales of GTG's COVID-19 Risk Test and further products2 within markets outside of the United States. The Company will provide further updates on regional releases as and when they are confirmed.

The commercial release is expected to occur no later than the end of May once the technical interface for the United States telehealth platform is completed by IBXs telehealth partners. Simon Morriss stated: "We are excited to be at the precipice of the commercial release of our COVID-19 Risk Test. With IBXs testing capacity of ~100,000 SARS CoV-2 Tests undertaken per day we look forward to seeing this rolled out and informing individuals of their risk of developing a serious case of COVID-19. Additionally, broadening the opportunity set by building a platform that can enable sales beyond the United States will be critical in streamlining market expansions and future product launches."

The Company will provide further details on the updated launch date for the COVID-19 Risk Test once confirmed between GTG, IBX and their telehealth partner.-ENDCOVID-19 Risk Test Approved for Commercial ReleaseMelbourne, Australia, [21] October 2020: Molecular diagnostics company GeneticTechnologies Ltd ((ASX: GTG, NASDAQ:GENE, "Company")), provides the following update to themarket.Key highlights Final testing and validation underway on the Company's COVID-19 Polygenic RiskSeverity (PRS) test with expected completion in the next four weeks Late stage discussions occurring with a US based laboratory to enhance potentialcapacity and provide large scale population testing for COVID-19 across the US Launch of the Australian Consumer Initiated Testing (CIT) platform for the sale ofGeneType for Breast Cancer and Colorectal Cancer Confirmation of submission of technical paper, An integrated clinical and genetic modelfor predicting risk of severe COVID-19', to a peer-reviewed journal for publicationGenetic Technologies confirms receipt of the Thermo Fisher arrays required for the final stagetesting of the COVID-19 PRS test. The laboratory validation has now commenced in GTG's CLIAAccredited lab in Australia and the Company anticipates that this process will be completedover the next four weeks. The testing will be based on pre-existing laboratory procedures forlab validation in accordance with our breast cancer and colorectal cancer protocols.Additionally, the Company has received confirmation that, subject to the completion of thefinal stage testing, that the COVID-19 PRS test kits will be able to be sold commercially in theUSA. As such, GTG has engaged in active discussions with a US based laboratory that will enablethe Company to significantly enhance capacity within the US allowing for large scale populationtesting. Further improvements to the utility of the tests are also underw