Dutch biotech firm SkylineDx has received CE-IVD Mark approval from the European Competent Authority for its MMprofiler prognostic test to determine the level of risk of a patient with multiple myeloma (MM).
The company is focused on developing and commercialising new gene signature-based tests to accurately determine the type or status of the disease, as well as to predict the patient’s response to a specific treatment.
Multiple myeloma is a type of blood cancer, which originates from plasma cells, a type of white blood cell that is made in the bone marrow.
MMprofiler allows physicians to use the SKY92 high-risk gene signature to more accurately measure the prognosis of a patient with multiple myeloma by classifying them into a high or standard risk group.
The company noted patients with a high risk classification will have poor prognosis compared to patients with a standard risk profile, irrespective of treatment.
SkylineDx CEO Dharminder Chahal said: "Receiving this CE-IVD Mark is our first and most significant commercialisation milestone for MMprofiler.
"We are one step closer to fulfilling our commitment to advancing the use of innovative gene signature-based tests to help physicians make better informed personalised treatment decisions for patients with multiple myeloma worldwide."
According to the firm, the performance of the SKY92 gene to risk stratify these patients exceeds current standard clinical parameters such as serum albumen levels and FISH, which is used in myeloma.
In the US, the company is providing MMprofiler for research use only, as it is not approved for clinical diagnostic use.