New bone fragility diagnostic device approved for sale in Europe

A new diagnostic device for bone fragility invented by the University Hospitals of Geneva (HUG) and the University of Geneva (UNIGE) has obtained marketing authorization in the European Economic Area and in Switzerland. Licensed by Northern Irish company ProAxsis, it launched this summer. The device is based on a new approach for assessing bone quality by blood sampling. This test is much more specific than current techniques and will significantly improve diagnosis and advance the development of new treatments for osteoporosis.

Bone fragility is a major public health problem. The first cause is osteoporosis, which affects 30% of the Swiss population. Type 2 diabetes, which affects 10% of the population, is a risk factor because it almost doubles the probability of fracture.

With the aging of the population, osteoporosis and fragility fractures are expected to increase by 23% in EU countries, from 2.7 million in 2017 to 3.3 million in 2030. In Switzerland, the annual number current 82,000 fragility fractures is expected to rise to nearly 105,000 in 25 years.

Bone fragility must be diagnosed before a fracture occurs, because depending on the age of the person and the bone involved, a fracture can lead to severe chronic pain and even increase the risk of death.

Read fracture risk in a drop of blood

The basis of this invention lies in the properties of the periosteum, a membrane that covers the bones and plays an essential role in their growth and repair. It secretes a key protein that controls the diameter of the bone and therefore its resistance: periostin. During the process of bone resorption, the enzyme cathepsin K degrades it. The fragment of digested periostin, called k-POSTN, is also found in the blood and thus reflects bone fragility. The interest of this fragment lies in its bone specificity, unlike intact periostin, known to scientists for a long time, but which can also increase in cardiovascular diseases and cancers. After a blood sample is taken, the amount of k-POSTN is measured in the laboratory using an ELISA test, a widely used method for measuring molecules in a biological sample.

Improving diagnosis

The new device has the potential to help healthcare professionals identify and monitor those most at risk of developing osteoporotic fractures as well as those with other bone-weakening conditions, including type 2 diabetes. In addition, it allows therapeutic intervention at an early stage, before a fracture occurs, which should undoubtedly reduce the burden of bone diseases on health systems and significantly improve the quality of life of patients.

A race with great potential

This device is intended to complement bone densitometry, which is the imaging technique currently used to assess bone fragility.

This is a process that can unfortunately be skewed in the case of type 2 diabetes. The increase in weight and fat mass typical of diabetes blurs the measurement of bone mineral density, which can appear normal even if a bone tissue fragile is present. The new device overcomes these limitations.”


Serge Ferrari, Head of the Bone Diseases Department at HUG, Full Professor in the Department of Medicine of the UNIGE Faculty of Medicine and co-inventor

Measuring k-POSTN improves the prediction of bone fragility by increasing the accuracy and specificity of techniques currently used to identify people at risk for bone fracture. “Our diagnosis will enable researchers and pharmaceutical laboratories involved in the development of new osteoporosis treatments to obtain precise, specific and quantitative measurements of the effect of their pilot products”, specifies Serge Ferrari.

A unique development process

This discovery is the fruit of the work of Professor Serge Ferrari and Nicolas Bonnet, a liberal physician in the Department of Medicine of the UNIGE Faculty of Medicine.

They first discovered this new process based on the direct measurement of a product of the biochemical process of natural bone degradation. They then started the development of the ELISA test in 2014. The HUG and the UNIGE filed a first patent in 2016, following which, the potential and the quality of the test interested the company ProAxsis Ltd, based in Northern Ireland, for a license in 2021. test received CE marking in June 2022 for marketing in Europe.

“It is rare for a product developed in a university hospital to be marketed. And even less in such a short time! We owe it to the excellent collaboration with our partners”, concludes Serge Ferrari.

Source:

Geneva University Hospitals (HUG)