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De Novo update

Oxford, UK. GENinCode Plc (AIM: GENI), the genetics company focused on the prevention of cardiovascular disease, announces an update on its Food and Drug Administration (FDA) De Novo submission. The FDA has provided full feedback on the application and determined that there remains certain outstanding elements, including deficiencies in relation to clinical validation, that need to be addressed.

The Company has initiated a Supervisory Review with the FDA to address these elements and is holding ongoing discussions and in-person meetings with the FDA to resolve these deficiencies. The Board does not believe that there are any elements that it cannot address, however there can be no certainty that the information provided will be sufficient. The Company will provide a further update at the Preliminary Results at the end of May 2025.

Early detection and prevention of ACAD

The prevention of ACAD must begin with early detection

and modification of risk factors. If behavioural and

metabolic risk factors, such as smoking, hypertension,

high cholesterol, and poor diet, were eliminated or

controlled early in life, the global burden of ACAD could

be dramatically reduced. Eliminating these risk factors

by 2050 could decrease the rate of ACAD deaths by

82·1%, potentially saving 8·7 million lives annually.

Public health initiatives should emphasise lifestyle

changes and the management of metabolic disorders to

prevent the onset of atherosclerosis.

Early detection and effective prevention remain a

challenge. The implementation of screening strategies to

identify individuals at risk of developing ACAD is crucial.

Targeted screening programmes, integrated into health-

care systems, can detect early signs of atherosclerosis

and enable timely intervention. Such interventions, if

applied early, have the potential to halt, delay, or even

reverse the progress of the disease, reducing the risk of

cardiovascular events in later life.

Addressing the global burden of ACAD

ACAD is not a uniform problem across the globe.

Disparities exist between high-income countries and

low-income to middle-income countries in terms of

prevention, diagnosis, and treatment. These differences

contribute to variations in health outcomes. Between

2022 and 2050, mortality rates from ACAD are forecasted

to increase by 19·2% in lower-middle-income countries

and 4·2% in upper-middle-income countries. This global

disparity underscores the importance of equitable access

to prevention, diagnosis, and treatment to reduce the

global burden of ACAD.

Health-care systems must be designed to prioritise

prevention and early detection of ACAD rather than

simply treating advanced disease. This prioritisation

requires a fundamental shift in the education and

training of health-care providers, with a focus on the

early stages of the disease and the integration of

prevention strategies into clinical practice.

Https://www.sciencedirect.com/science/article/abs/pii/S0140673625000558

Executive summary

Coronary artery disease has long been understood through the paradigm of epicardial coronary artery obstruction, causing myocardial ischaemia (a mismatch between myocardial blood supply and demand). However, this model, which focuses on diagnosing and managing coronary artery disease based on ischaemia and cardiovascular events, is flawed. By the time ischaemia manifests, it is often too late for optimal intervention, limiting the effectiveness of treatment options.

Scope and aims

With this Commission, we aim to shift the focus towards ACAD, to consider the risk factors and continuum of systemic atherosclerosis, and to move away from the historical attention on late sequelae of the disease in terms of obstructive epicardial coronary stenoses and ischaemia. We identify areas of need for future research with an overarching goal of reducing the global burden of ACAD and related morbidity and mortality. We will focus on the risk factors, prevention, diagnosis, and treatment

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00055-8/abstract

The Lancet Group Commission on rethinking coronary artery disease, authored by some of the world’s leading cardiologists.

“The key message: we must shift from reacting to often deadly ischaemic events to preventing atheroma, the plaque that silently builds in arteries long before symptoms appear.

It’s a bold, forward-looking change: from reacting to heart attacks, to preventing them at the root.

And it raises a crucial question:

- Is there a better tool than polygenic risk scores (PRS) to identify individuals at high risk of plaque formation, early and accurately before any syntoms appear?

PRS is often compared to coronary calcium score (CAC), but there's a key difference: CAC detects the disease once it's already progressing. PRS, on the other hand, gives physicians the chance to intervene before atheroma develops, perfectly aligned with this shift proposed by The Lancet working group.

PRS was even described as the “first risk factor” in a 2018 JACC commentary by Pradeep Natarajan, a powerful statement that underscores the role of genomics in truly proactive prevention, as it reveals risk before traditional markers can.

The future of cardiology is about fighting atheroma early, not waiting for ischaemia.

This is how we can win the battle against heart disease.”

FDA take note. - CARDIO inCode® - GENI

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