GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease, provides the following trading and progress update ahead of its financial year end on 31 December 2021.
Following the successful admission to AIM in July 2021 and ramp-up in operations over the second half of this financial year, the Company is now moving towards a number of important milestones which will drive its growth and profile over the coming years.
These milestones are expected to accelerate the Company's commercial programme to lift the Standard of Care for cardiovascular disease ("CVD") by enabling more precise patient diagnosis and risk stratification to improve preventative care.
The Company is focused on delivering the plans set out in its admission document, especially around the preparation for the US launch of Cardio inCode® in 2022. In summary:
· Cardio inCode® de-novo submission for US regulatory approval with the FDA - The Company continues to have constructive and ongoing discussions with the FDA and is finalising its de-novo application. The de-novo submission is expected to be filed by the end of this year.
· Breakthrough Device Designation (FDA) for Cardio inCode® - Discussions continue to progress with the FDA to advance Cardio inCode® as a 'Breakthrough device'. Discussions have been extended partly due to FDA workload, but also resulting from a detailed assessment of GENinCode's CVD prognostic device which, in turn, has given the Company confidence to file its de-novo submission earlier than it might otherwise have planned. The Company remains well placed to complete this process over the coming months.
· Cardio inCode® launch programme with EVERSANA Life Sciences LLC for introduction to US market in 2022 - The Company is working closely with its new collaborative partner EVERSANA to finalise the programme for the Cardio inCode® launch, expected in H2 2022. The EVERSANA health team comprises of a multi-disciplined group of experts covering market access, reimbursement, regulatory and field sales, supporting the commercial development of the Company's US programme.
· CPT coding for Cardio inCode® and commencement of CMS payer and reimbursement discussions - The Company is now finalising the CPT-PLA coding draft and expects to file its coding application in Q1 2022. CMS discussions are anticipated to commence regarding reimbursement in the New Year.
· Royal Brompton & Harefield set-up and commissioning for Lipid inCode® hypercholesterolemia testing - The Company has successfully completed the validation of its hypercholesterolemia testing at the Royal Brompton Hospital Genetic Labs in London and expects to start commercial testing with UK private payers and NHS Academic Health Science Networks (AHSNs) over the coming month.
· Indiana University and New York Presbyterian collaborations - The Company is finalising collaborative agreements with both these flagship facilities to advance the clinical diagnosis of CVD. Initial collaborative work will focus on the introduction of Cardio inCode® and Thrombo inCode® products for CVD and COVID-19 clinical study assessment.
· US CLIA (Clinical Laboratory Improvement Amendments) authorised testing facility - Discussions are ongoing with a number of CLIA labs to implement Cardio inCode® genetic test service delivery for the US market. The Company expects to announce further CLIA developments over the coming months.
· UK Hypercholesterolemia study for Lipid inCode® - The NHS 'Evaluation of novel rapid genomic test (Lipid inCode®) including polygenic risk scores for the diagnosis and management of Familial Hypercholesterolaemia' study is due to report its findings in the international journal 'Global Cardiology Sciences and Practice' over the coming months. The publication is currently with the editorial board.
· First COVID-19 Thrombo inCode® evaluation study for genetic predisposition to thrombosis - St. Pau hospital, Barcelona - Preliminary data from the Company's first COVID-19 study indicates that there is a correlation between inherited thrombophilia (blood clotting) and more severe complications for individuals suffering with COVID-19. Preliminary data from a second COVID-19 study is anticipated over the coming months.
· Trading outlook - Over the H2 2021 reporting period the Company has seen increased EU product revenues in line with market guidance.
Matthew Walls, CEO of GENinCode Plc said: "Since admission in July, we have made solid progress in delivering the key milestones set out in our business plan. The business is developing swiftly and we are increasing our investment in key resources and expertise to take advantage of growth opportunities opening to us and strengthening our Board to include a greater US market presence, awareness, and expertise to reflect our long-term goals. We look forward to updating the market and our shareholders in due course."