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SkylineDx diagnostic tests conquer Europe

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SkylineDx diagnostic tests conquer Europe

The Rotterdam biotech company SkylineDx was established in 2013 and was a relaunch of precursor Skyline Diagnostics. A new trail was blazed and all of the company’s energy was channelled into MMprofiler, a diagnostic test for a form of blood cancer.

Business development manager Nicky Vogels said, ‘Having recently obtained CE-IVD registration, we are now able to sell MMprofiler on the European market. This is an important step forwards for us.’

SkylineDx is based on the 18th floor of the Erasmus MC Incubator, the number one place for start-ups to develop. Vogels: ‘We have grown quickly since then. Our scientific, commercial and support team now consists of more than 25 people.’ The breakthrough product – the MMprofiler – is a diagnostic test that uses a patient’s genetic profile to predict how his/her illness will progress, by establishing whether the patient has a high or standard risk profile. A high risk profile goes hand in hand with a poorer prognosis. The disease in question is a life-threatening type of blood cancer: Multiple Myeloma (MM). ‘We work closely in this case with the Department of Haematology at the Erasmus MC.’

Relaunch
When investor Van Herk Investments became involved in the relaunch, focus shifted to the MMprofiler and brought success. In the autumn of 2015, the company gained European approval (CE-IVD marking) to sell the test on the European market, which was an important development. ‘We use a so-called decentralised business model, which involves us supplying complete diagnostic kits that enable local laboratories to use their standard equipment to carry out the tests themselves. The patient’s tissue sample – bone marrow in this case – doesn’t need to leave the lab to perform the test, which is something that hospitals consider a major advantage.’

The United States
The company is working hard to broaden its product portfolio by developing tests for other types of disease: ‘Although we are primarily interested in oncology, we are also exploring other areas. In principle, we have everything we need to develop diagnostic tests for other diseases. There is a great demand for new biomarkers and diagnostic tests that contribute to the concept of so-called personalised medicine. Although this market has huge potential, relatively few diagnostic tests are being launched right now. We have now opened an office on the west coast of the United States. The object is to put the MMprofiler on the market there too.’ V.O. and Vogels are working together to decide which patent strategy to pursue: ‘What we will do in which country when applying for and managing our patents.’

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