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With the support of new EHTEL member, Amgen.

Amgen, a new EHTEL member, is a world leader in biotechnology. The company’s European Hub is based in Rotkreuz (Zug) in Switzerland.

Given EHTEL’s interest in the Medical Devices Regulation, Amgen told the association about its FH Score tool.

Developing a scoring tool

Back in 2017/18, Amgen was already focused on software as a medical device. The company’s first software to be recognised as a medical device – Software as a Medical Device – was its ‘FH Score.

‘FH Score’ is scoring tool that helps healthcare professionals to diagnose patients with familial hypercholesterolemia (FH). FH is an inherited genetic disorder that benefits from DNA testing of individuals and their at-risk relatives. Today, some 85% of people with the disorder have not yet been diagnosed. On average, the disorder affects one person in 500 – in some European countries this is as many as one in 250.

The FH Score tool has been endorsed by the European Atherosclerosis Society. More than 10 other medical associations from as far and wide as Australia to Slovenia also support the tool.

How does the tool work?

FH Score demonstrates the need to develop a robust system for identification and management of FH patients in primary care.

The FH Score tool identifies high-risk patients with cardio-vascular conditions through use of a range of materials: educational tools; speaker training; a sample audit tool based on data extracted from electronic medical records; and a tool to undertake a ‘voluntary audit’.

The initiative can flag up patients who are either at risk of FH or who have it. The fact that these patients can get access to preventative treatments earlier leads to better overall outcomes for them.

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Working together is important

An initiative like FH Score often needs many partners who work together collaboratively. Among Amgen’s partners in this venture were people in an EIT Health consortium. Included were the University of Maastricht (Netherlands), medical societies in both the Netherlands and Spain, and the Irish College of General Practitioners.

Ultimately, the ambition is for FH Score to be used by health care professionals in at least 12 countries. Used with more than 48,000 patients to date, it has helped to identify some 35,000 patients at risk of or who have the condition.

FH Score clearly highlights the importance of genetics and genomics. This is just one reason that EHTEL plans to cover genetic challenges in its 2021 Thought Leaders Symposium. The association looks forward to learning more about biotechnology through its collaboration with Amgen.

For more info on FH:

  • DigitalHealthEurope, a project in which EHTEL is involved, explored the importance of genomics.
  • One country took the FH Score work further. Public Health England developed detailed guidance on the condition.



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