Genincode Regulatory News (GENI)

GENinCode Plc

("GENinCode" or the "Company")

Collaboration with Indiana University School of Medicine

Study for testing Cardio inCode-SCORE for the risk of onset of cardiovascular disease

Oxford, UK. GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease, announces its collaboration with the Indiana University School of Medicine ("IU"). IU is the largest medical school in the US and will undertake a 'Proof of Concept' study using Cardio inCode-SCORE for the risk assessment of patients for onset of atherosclerotic cardiovascular disease ("ASCVD"). ASCVD accounts for over 85% of all cardiovascular disease deaths and is the leading cause of morbidity and mortality in the US and globally.

According to the Centres for Disease Control and Prevention ("CDC"), cardiovascular disease ("CVD") is the number one cause of death in the United States and the decades‐long trend towards lower cardiovascular mortality rates has begun to reverse, with an increase in total mortality during recent years: https://www.cdc.gov/heartdisease/facts.htm.

CVD disproportionately affects people of lower socioeconomic status, and those of non‐white ethnicity. Early identification of subclinical disease in the population can lead to better primary prevention of heart attack and stroke. Current American College of Cardiology ("ACC") guidelines call for risk stratification using validated instruments, such as the US National Heart Lung and Blood Institute ("NHLBI") pooled risk cohort equation, drawing on clinical parameters readily available such as blood pressure and cholesterol levels. In addition, the guidelines endorse the use of "risk enhancing factors" such as the Coronary Artery Calcium ("CAC") score, undertaken using computerised tomography ("CT") imaging of the coronary arteries.

Whilst acknowledging family history as a risk factor, current guidelines have not yet incorporated the potential of genetic risk assessment in the prediction of ASCVD. Cardio inCode-SCORE provides an opportunity to apply advanced polygenic testing to improve patient risk assessment and prognosis, in a widely available form and at reduced cost compared with other test modalities.

The primary aim of the IU study is to evaluate the association between the Cardio inCode-SCORE genetic risk score ("GRS") and the presence of subclinical coronary atherosclerosis evaluated by CAC.

CVD is a broad disease classification which encompasses conditions such as coronary artery disease (causing angina, heart attacks, heart failure), cerebrovascular disease (causing stroke, and some dementia), peripheral vascular disease (causing limb ischemia, and some chronic kidney disease) and venous thromboembolism. CVD is the leading cause of death and disability worldwide accounting for one in every four deaths in the United States. According to the US National Institutes of Health ("NIH"), by 2030, the global cost of CVD is set to rise to US$1,044 billion, from approximately US$863 billion in 2010, and is both a major health issue and global economic burden.

GENinCode has a vision to assist clinicians and inform patients about cardiovascular risk, and to improve public health using the predictive capability of genomics. High genetic risk patients are assisted in making lifestyle choices and can receive targeted treatment to improve outcomes. Over the past 15 years, GENinCode has made a substantial investment in its research, bioinformatic data, technology, and product development to assess disease risk, in order to help clinicians and patients prevent the onset of CVD.

Matthew Walls, CEO, GENinCode said: "We are delighted to work with the IU School of Medicine and to introduce Cardio inCode-SCORE to the IU health community. The IU study follows on from our recently published US clinical performance studies showing the substantive predictive capability of the Cardio inCode-SCORE product for the risk assessment of patients for the onset of cardiovascular disease. We look forward to working closely with the IU team to successfully deliver the programme."

Richard Kovacs MD, Q.E. and Sally Russell Professor of Cardiology in the Division of Cardiovascular

Disease at IU School of Medicine commented: "The GENinCode and IU collaboration offers the potential to improve the prediction of ASCVD and better assess patient risk of future CVD events. GRS's provide an opportunity to enhance assessment of risk based on 'classic' CVD risk factors and help physicians identify patients at higher inherited genetic risk, thereby targeting improved treatment and reduction in future CVD events. IU welcomes this approach and we look forward to working with Cardio inCode-SCORE to advance preventative CVD care."

For more information visit www.genincode.com

About GENinCode:

GENinCode Plc is a UK based company specializing in genetic risk assessment of cardiovascular disease. Cardiovascular disease is the leading cause of death and disability worldwide.

GENinCode operates business units in the UK, Europe through GENinCode S.L.U, and in the United States through GENinCode U.S. Inc.

GENinCode predictive technology provides patients and physicians with globally leading preventative care and treatment strategies. GENinCode CE marked invitro-diagnostic molecular tests combine clinical algorithms and bioinformatics to provide advanced patient risk assessment to predict disease onset.

About Indiana University School of Medicine

IU School of Medicine is the largest medical school in the United States. Comprised of five basic science departments and 20 clinical departments, IU School of Medicine offers exceptional training for students wishing to pursue a medical degree. With the Class of 2020, the school implemented a new medical education curriculum that better reflects the modern U.S. health care environment and delivery models, readying students to practice medicine in a team-based, interdisciplinary setting.

· Statewide medical education centers on six core competencies.

· Access to diverse patient populations reflects true state of care today.

· Updates align innovations in medical science and education.

· Global outreach, clinical education programs foster active learning.

· Collaborative teaching and learning forges interprofessional bonds.

· Academic advising and career counseling support and guide students.

About Cardiovascular Disease (CVD or Heart Disease) in the US: Centres for Disease Control Prevention information (CDC)

· Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States.

· One person dies every 36 seconds in the United States from cardiovascular disease.

· About 659,000 people in the United States die from heart disease each year-that's 1 in every 4 deaths.

· Heart disease costs the United States about $363 billion each year from 2016 to 2017.2 This includes the cost of health care services, medicines, and lost productivity due to death.

Coronary Artery Disease/Coronary Heart Disease

· Coronary heart disease is the most common type of heart disease, killing 360,900 people in 2019.

· About 18.2 million adults age 20 and older have CAD (about 6.7%).

· About 2 in 10 deaths from CAD happen in adults less than 65 years old.

Heart Attack

· In the United States, someone has a heart attack every 40 seconds.

· Every year, about 805,000 people in the United States have a heart attack.  Of these,

o 605,000 are a first heart attack

o 200,000 happen to people who have already had a heart attack

o About 1 in 5 heart attacks is silent-the damage is done, but the person is not aware of it.