Theradiag’s Biotherapy Monitoring Test Gets CE Mark

Theradiag’s Stelara biotherapy monitoring test, which offers theranostic biotherapy tools for autoimmune disease patients, has earned a CE mark, the company said Wednesday.

A fully human monoclonal antibody, Stelara (ustekinumab) targets the cytokine IL-12 and IL-23 proteins and is meant for patients suffering from moderate to severe plaque psoriasis and psoriatic arthritis, the French diagnostics maker said. The tests monitors patients’ performance on the drug.

Theradiag claims to be the only company in the world to offer a wide range of monitoring tests for the treatment of autoimmune and inflammatory diseases. The Stelara monitoring test is the tenth in the company’s Lisa Tracker line.

Psoriasis afflicts 2 percent to 3 percent of the world’s population.

Sales of Stelara were $1.3 billion last year, the company said. — Jason Scott