French IVD company Biomedical Diagnostics reported the achievement of a CE mark for its LISA TRACKER Premium kits. CE Mark approval means the products will be commercially available throughout Europe. The LISA TRACKER Premium kits are designed for monitoring patients undergoing treatment for autoimmune diseases. They enable the simultaneous assay of TNFalpha, anti-TNF therapeutics including infliximab, Etanercept, and adalimumab, and neutralizing antidrug antibodies.
BMD claims correlation of the three parameters measured by the LISA TRACKER kits is essential for defining and predicting a patient's treatment response. In combination with clinical data, the assay results are designed to help physicians establish an individual patient's resistance profile and optimize the management of a range of autoimmune diseases, including chronic rheumatoid arthritis and ankylosing spondylitis in rheumatology, Crohn disease and hemorrhagic colitis in gastroenterology, and psoriatic arthritis in dermatology.
BMD already markets 10 kits in its FIDIS® range for the diagnosis of autoimmune diseases, and 30 ELISA and DOT assays.