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XTEK Limited (ASX:XTE) (“XTEK” or the “Company”) is pleased to announce it has signed an exclusive distribution agreement with KeyOptions Pty Ltd (“KeyOptions”) for the sale and support of Virolens® in Australia, New Zealand and the Pacific independent states.

Key highlights 

–  XTEK has signed an exclusive distribution agreement with KeyOptions for the sale and support of Virolens

–  The initial term of the agreement is two years

–  Virolens screens for SARS-CoV-2, that causes the disease called COVID-19, in approximately 20-30 seconds

–  The Virolens product has been accepted by the UK MHRA for registration as an in vitro diagnostic (IVD) Medical Devices Directive 98/79/EC; and an application has been lodged with the TGA for registration as a Class 1 IVD medical device

XTEK has signed an agreement with KeyOptions, a master agent for Virolens. The agreement appoints XTEK as the exclusive distributor in Australia, New Zealand, the Pacific independent states and specific named accounts outside the Australian region. The initial term of the agreement is two years, with year-to-year automatic renewal thereafter. Exclusivity is subject to minimum sales requirements in year 1. Subject to regulatory and other relevant approvals, XTEK will supply Virolens products, consumables, training and maintenance to end users, third party service providers and others who will carry out testing at sites.

Virolens is designed to screen for SARS-CoV-2 in approximately 20-30 seconds (98.1% sensitivity [true positive], 99.7% specificity [true negative] based on results of an internal in-vitro validation study – 184 samples). Virolens is made by a UK start-up, i-Abra, and manufactured by a listed company in the UK.

The Virolens product has been accepted by the UK Medical and Healthcare product Regulatory Agency (MHRA) and an application has been lodged by KeyOptions with the Therapeutic Goods Administration (TGA) in Australia.

Revenues to XTEK from the sale of Virolens are subject to the TGA approval and are dependent on potential end customers converting expressions of interest into firm orders. There continues to be a wide range of potential commercial outcomes and hence no certainty as to the financial impact on XTEK.