SkylineDx

The Rotterdam biotech company was established in 2013 from a restart of the former Skyline Diagnostics. They changed course and all energy was put into the MMprofiler, a diagnostic test for a form of blood cancer.

Business development manager Nicky Vogels: “With the recently acquired CE-IVD registration, we can now sell the MMprofiler on the European market, an important step.” SkylineDx is located on the 18th floor of the Erasmus MC Incubator, a place where startups can develop. Vogels: “Since then, we have grown fast. We now have over 25 scientific, commercial and support staff.” The breakthrough product, the MMprofiler, is a diagnostics test that can predict the genetic profile of a patient over the course of their illness by establishing whether this patient has a high- or standard-risk profile. A high risk profile is coupled with a poorer prognosis. It involves the life-threatening disease Multiple Myeloma (MM), a form of blood cancer. “We are working closely with the Hematology department at Erasmus MC.”

‘With the recently acquired CE-IVD registration, we can sell the MMprofiler on the European market, an important step.’

Nicky Vogels – SkylineDx

Restart

When investor Van Herk Investments joined the restart, the focus shifted to the MMprofiler. With success. In autumn of 2015, they followed the important European approval process (CE-IVD Marking) to sell the test on the European market. “We use a so-called decentralized business model, which means we supply complete diagnostic kits so local labs can run the tests on their standard equipment. The patient’s tissue sample, in this case bone marrow, doesn’t have to leave the lab and the hospitals see that as a major advantage.”

United States

The company is also working hard on expanding their product portfolio by developing tests for other disease groups. “We are focused on oncology but we are also exploring areas beyond that. In principle, we have everything we need to develop diagnostic tests for other diseases. There is a dire need for new biomarkers and diagnostic tests which contribute to the concept of personalized medicine. This market has high potential and yet relatively few diagnostic tests are marketed. We have since opened a branch on the west coast of the United States with the goal to also enter the market there with the MMprofiler.” Vogels is working with V.O. on the patent strategy they will pursue: “What will we do in each country in relation to applying for and managing our patents?”