Genincode Regulatory News (GENI)

GENinCode Plc

("GENinCode" or the "Company")

Positive Thrombo inCode clinical results

Case study carried out with the Karolinska Institute

GENinCode Plc (AIM: GENI), Oxford, UK, the cardiovascular disease company focused on predictive genetics for the prevention of cardiovascular disease, announces the publication of its Thrombo inCode® prospective case-control study performed at the Karolinska Institute, Sweden.

The study returned positive clinical results which strengthen Thrombo inCode® as a leading diagnostic product for the diagnosis of inherited thrombophilia and venous thromboembolism ("VTE") risk assessment. The Karolinska Institute is one of the world's leading medical universities with a vision to advance knowledge about life and strive towards better health for all. 

Thrombo inCode® is CE Marked and one of the Group's three primary products of commercialisation focus over the immediate term. Thrombo inCode® is focused on the diagnoses of genetic thrombophilia and assesses thrombotic risk. Thrombophilia is a condition where there is an imbalance in naturally occurring blood clotting proteins or clotting factors giving rise to the formation of blood clots. Inherited thrombophilia arises from genetic factors which affect the blood clotting mechanism, with clotting events increasingly recognised as a significant source of cardiovascular events, mortality and morbidity.

In the Karolinska study, Thrombo inCode®'s performance was tested against the current diagnostic Standard of Care for thrombophilia, including Factor V Leiden and Prothromobin, and a combination of genetic and clinical risk scores. The Thrombo inCode®results showed Thrombo inCode®'s predictive capacity was superior to the current Standard of Care, with a much higher sensitivity allowing the identification of 2.5 times more patients with hereditary thrombophilia. The study publication can be viewed at https://www.thieme-connect.com/products/ejournals/pdf/10.1055/s-0041-1729626.pdf 

There is a growing increase in patients with cardiovascular diseases ("CVD") and cancer risk owing to adoption of smoking, alcohol, increasing obesity, lack of physical activity and consumption of high cholesterol food. CVD and cancer patients also have a high risk of VTE, with cancer patients having a higher risk of developing blood clots with associated treatment procedures along with their inherited genetics. The growing incidence in CVD and cancer and other contributing risk factors means the demand for VTE diagnosis and treatment is growing. VTE treatment market size exceeded USD $950 million in 2020 and is expected to expand at over 8.7% CAGR from 2021 to 2027.

Thrombo inCode® clinical utility has also been proven and validated in a Southern European group (Soria et al., JAHA 2014) and in Afro-Americans (McInnes et al., Human Mutation 2019), where it is increasingly recognised as the Gold-Standard for VTE risk prediction.

Matthew Walls, CEO, GENinCode Plc said: "The Karolinska Institute study provides further evidence for Thrombo inCode® and the importance of understanding the genetic characteristics of the patient to properly assess risk and precisely align appropriate therapeutic treatment. We are delighted by the study results and grateful to the team at the Karolinska Institute for their significant contribution."

About Thrombo inCode®

The Thrombo inCode® genetic test analyses genetic variants related to hereditary thrombophilia and the risk of venous thromboembolism (VTE). Thrombo inCode® genetic diagnosis has been published in a number of scientific journals and the Company's test has begun to be implemented in hospitals and laboratories in Europe. Thrombo inCode® provides individuals who have a family history of thrombosis with detailed information regarding hereditary thrombophilia to help prevent the occurrence of thrombosis and identify treatment pathways, as well as reduce the risk of recurrence.

The symptoms of thrombosis include swelling, localised warmth, pain and reddening of the affected area, caused by a clot that blocks blood flow. It generally occurs in the deep veins of the lower limbs and is also known as deep vein thrombosis (DVT). The most severe complication of thrombosis is a pulmonary embolism, caused by a clot that affects blood flow in the pulmonary arteries. By carrying out a thrombophilia test, it is possible to determine whether an individual's genetic profile increases their risk of thrombosis. At present, two genetic variants are usually measured as the Standard of Care, Factor: V Leiden; and Prothrombin. However, there are other thrombosis-related genetic variants that can be considered which are captured by the Thrombo inCode® test. Studies have highlighted that a clinical-genetic score integrating the variants of Thrombo inCode® has good predictive capacity to identify patients with a high risk of thrombosis recurrence.

The Thrombo inCode® test personalises therapy options for patients, including oral anticoagulants, such as Warfarin, Xarelto, Eliquis and/or Heparins.

About GENinCode plc

GENinCode plc (AIM: GENI) is engaged in the risk assessment, prediction and prevention of cardiovascular disease ("CVD"). CVD is the leading cause of death worldwide accounting for approximately 18 million deaths annually. The Company's products and technology have been developed with the aim of predicting the onset of CVD and providing a personalised treatment pathway for patient management. Its products have been the subject of clinical studies on over 75,000 patients to assess and predict the onset of CVD.

The Company was incorporated in September 2018 to acquire the assets, intellectual property and know-how of the Ferrer inCode and Gendiag.exe businesses, which were then part of Grupo Ferrer Internacional S.A., a large Spanish multinational private pharmaceutical and healthcare company. The technology and products acquired included Cardio inCode®, Lipid inCode®, Thrombo inCode® and Sudd inCode®. The Directors believe that approximately €50 million has been invested in the research and development of these products since 2007. The Company has begun to commercialise these products in Europe and is now targeting the UK and US.