Genetic Signatures

11 North America Sales progress The USA remains the largest molecular diagnostics market globally so is a focus for Genetic Signatures. The Group acquired its first customers in USA during the financial year for SARS-CoV-2 testing and this contributed $1.6m in revenue. Overall, COVID-19 testing volumes in the USA have reduced from their peak in Dec 2020 which impacted the Company's volumes in the 4th quarter. North America also includes Canada, and we were pleased to announce the appointment of Somagen Diagnostics as a distributor. Somagen Diagnostics is a leading provider of innovative technologies over the past 25 years committed to providing patient focused clinical diagnostic solutions across Canada. Genetic Signatures identified that testing for Enteric Protozoa (parasites) is an underserved market in the USA, and this offers a significant opportunity for molecular tests using our 3base ™ technology to greatly enhance this testing capability. There are an estimated 5.5 million tests done per annum and achieving a 40% market share could generate up to US$88m per annum for Genetic Signatures. Regulatory update To gain access to the Enteric Protozoan testing market Genetic Signatures needs to secure US Food and Drug Administration (510k) clearance for its EasyScreen ™ diagnostics kit. A key component of the application is provision of clinical data from 3 US trial sites and a minimum 1,500 samples. Sites have been selected and data collection is underway, though access to “live” samples has been hampered by delays due to the pandemic. The first site has almost completed its data collection, the second site is in progress, and the last site has been initiated and is ready to start. The company is still confident that a submission will be lodged by the end of the year, however this will depend on patient recruitment numbers. Market analysis is also being undertaken to determine the next products to pursue FDA clearance. Regions Commercialisation Update