Approval of California state license and CLIA certification opens US market
Oxford, UK. GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease (“CVD”), announces California state licensing approval and CLIA certification of its Irvine laboratory in California, enabling the provision of its products for the risk assessment of CVD to patients across 49 states in the United States.
The approval of the California state license by the California Department of Public Health and CLIA certification from the Centers for Medicare and Medicaid Services (CMS) marks a major milestone in the commercialisation of the Company’s ‘first in class’ polygenic CVD products CARDIO inCode® and LIPID inCode®, which can now to be sold across the US and serviced from the Company’s California CLIA lab.
CARDIO inCode® measures an individuals inherited genetic risk of coronary heart disease with the complementary FDA 510K submission for a CARDIO inCode® kit (for use by other CLIA labs) to be filed shortly. LIPID inCode® measures an individuals inherited genetic inability to metabolise LDL-C cholesterol (LDL-C is often referred to as ‘bad cholesterol’) giving rise to accelerated onset of heart disease. CARDIO inCode® and LIPID inCode® are now being prepared for entry into Early Access Programs with US revenue growth forecast from 2023.
According to the US Centres for Disease Control (CDC), heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States.1 One person dies every 34 seconds in the United States from cardiovascular disease.1 About 697,000 people in the United States died from heart disease in 2020 – which is one in every five deaths.1,2 Heart disease cost the United States about $229 billion each year from 2017 to 2018.3 This includes the cost of health care services, medicines, and lost productivity due to death.
CARDIO inCode® measures the coronary genetic risk of a patient suffering a heart attack or cardiovascular event. This new genetic information allows physicians to gain insight to a patient’s coronary genetic risk score allowing more effective and earlier treatment to prevent heart disease. Physicians can now advise patients on their genetic risk of a coronary event and establish necessary changes to their lifestyle (e.g. reducing smoking, drinking or improving eating habits) as well as prescribing therapeutic treatment (e.g. statins, PCSK9i or other cholesterol lowering drugs) to prevent heart disease.
Matthew Walls, Chief Executive Officer of GENinCode Plc said: “The approval of the California state license and CLIA certification enables us to begin to sell our products across the US market. There has been a tremendous work effort to deliver these approvals representing a major advance in the Company’s commercial programme. We continue to work closely with our US partner collaborators on launch planning and advancing our Early Access Programs in preparation for commencement of US revenues in 2023.”
For more information visit www.genincode.com
Matthew Walls, CEO www.genincode.com or via Walbrook PR
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GENinCode Plc is a UK based company specialising 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, in the United States through GENinCode U.S. Inc and in Europe through GENinCode S.L.U.
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 Cardiovascular Disease
Cardiovascular disease (CVD) is the leading cause of death globally, taking an estimated 17.9 million lives each year. CVD is a group of disorders of the heart and blood vessels that include coronary heart disease, cerebrovascular disease, rheumatic heart disease and other conditions. More than four out of five CVD deaths are due to heart attacks and strokes, and one third of these deaths occur prematurely in people under 70 years of age.
The most important behavioural risk factors of heart disease and stroke are unhealthy diet, physical inactivity, tobacco use and harmful use of alcohol. The effects of behavioural risk factors may show up in individuals as raised blood pressure, raised blood glucose, raised blood lipids, and overweight and obesity. These “intermediate risks factors” can be measured in primary care facilities and indicate an increased risk of heart attack, stroke, heart failure and other complications.
Cessation of tobacco use, reduction of salt in the diet, eating more fruit and vegetables, regular physical activity and avoiding harmful use of alcohol have been shown to reduce the risk of cardiovascular disease. Health policies that create conducive environments for making healthy choices affordable and available are essential for motivating people to adopt and sustain healthy behaviours.
Identifying those at highest risk of CVDs and ensuring they receive appropriate treatment can prevent premature deaths. Access to noncommunicable disease medicines and basic health technologies in all primary health care facilities is essential to ensure that those in need receive treatment and counselling.
CVD causes a quarter of all deaths in the UK and is the largest cause of premature mortality in deprived areas and is the single biggest area where the NHS can save lives over the next 10 years. CVD is largely preventable, through lifestyle changes and a combination of public health and NHS action on smoking and tobacco addiction, obesity, tackling alcohol misuse and food reformulation.
Genetic risk assessment can help early detection and treatment of CVD to help patients live longer, healthier lives. Many people are still living with undetected, high-risk conditions such as high blood pressure, raised cholesterol, and atrial fibrillation (AF). Progress continues in the NHS to identify and diagnose people routinely knowing their ‘ABC’ (testing and monitoring of AF, Blood pressure and Cholesterol) set out in the NHS 10 Year plan.
Coronary heart disease (CHD) is the most common type of heart disease in the US, killing 382,820 people in 2020. About 20.1 million adults age 20 and older have CHD (about 7.2%).2 In 2020, about 2 in 10 deaths from CHD happen in adults less than 65 years old.2 Early Action Is Important for Heart Attack.
In the US, someone has a heart attack every 40 seconds.2 Every year, about 805,000 people in the US have a heart attack.2 Of these,
- 605,000 are a first heart attack2
- 200,000 happen to people who have already had a heart attack2
- About 1 in 5 heart attacks are silent—the damage is done, but the person is not aware of it.2
- Centers for Disease Control and Prevention, National Center for Health Statistics. About Multiple Cause of Death, 1999–2020. CDC WONDER Online Database website. Atlanta, GA: Centers for Disease Control and Prevention; 2022. Accessed February 21, 2022.
- Tsao CW, Aday AW, Almarzooq ZI, Beaton AZ, Bittencourt MS, Boehme AK, et al. Heart Disease and Stroke Statistics—2022 Update: A Report From the American Heart Association. Circulation. 2022;145(8):e153–e639.
- Agency for Healthcare Research and Quality. Medical Expenditure Panel Survey (MEPS): household component summary tables: medical conditions, United States. Accessed April 8, 2021.