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• • AvactaⓇ Avacta Group plc ( " Avacta " , the " Company " or the " Group " ) 30 September 2021 Interim Results for the Period Ended 30 June 2021 and Business Update Transformative period for both Diagnostics and Therapeutics Divisions Avacta Group plc ( AIM : AVCT ) , a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre | CISION ™ platforms , announces its interim results for the period ended 30th June 2021 and business update . Operating Highlights Avacta Diagnostics • Transformation of Diagnostics Division to become an ISO 13485 accredited in - vitro diagnostic ( IVD ) products business , and first sales ( post - period ) of its high performance AffiDX® SARS - CoV - 2 antigen lateral flow test . Global profile of Avacta and the AffimerⓇ diagnostic reagents platform substantially increased over the period . Clinical validation study of Avacta's AffiDX® SARS - CoV - 2 antigen lateral flow test carried out on 98 positive COVID - 19 samples ( 31 with Ct < 26 ; 65 with Ct 26-30 and 2 with Ct 30-31 ) and 102 negative samples demonstrates clinical sensitivity of 98.0 % and clinical specificity of 99.0 % . Additional data obtained post - period end from a further 134 negative samples has further defined the clinical specificity to be 99.6 % . AffiDXⓇ SARS - CoV - 2 antigen lateral flow test shown to detect the Delta variant of the SARS - CoV- 2 virus in clinical samples and to outperform two lateral flow antigen tests that are widely commercially available in Europe . The test has also been shown to detect the Alpha , Beta and Gamma variants in an earlier study . Declaration of conformity for CE mark for professional use of AffiDX® SARS - CoV - 2 antigen lateral flow test submitted to Medicines and Healthcare products Regulatory Agency ( MHRA ) . Product registration received , in both the UK and EU , for the professional use AffiDXⓇ SARS - CoV- 2 antigen lateral flow test . • Multiple collaborations and commercial partnerships entered into during the period and post- period end : • O Royalty bearing license agreement with Biokit , a Werfen Company , to develop and commercialise an undisclosed AffimerⓇ - based in - vitro diagnostic test . ○ Collaboration agreement with Bruker Corporation to evaluate the clinical utility and commercial potential of a mass spectrometry - based SARS - CoV - 2 antigen test developed with Adeptrix Inc. Global distribution agreement with ABCAM plc ( AIM : ABC ; NASDAQ : ABCM ) to sell the Group's recently developed AffiDX® SARS - CoV - 2 research ELISA AffimerⓇ reagents . Non - exclusive distribution agreement with Calibre Scientific Inc. ( " Calibre " ) , a global provider of life science products , for Avacta's AffiDXⓇ SARS - CoV - 2 antigen lateral flow test for professional use in the UK and European Economic Area ( EEA ) . Post - period Highlights ISO13485 certification attained by Avacta Diagnostics Division . • Shipment of AffiDX® SARS - CoV - 2 antigen lateral flow test commenced .