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CE Marking of Theranostic Monitoring Test Announced at 2015 AACC Annual Meeting

By LabMedica International staff writers
Posted on 27 Jul 2015
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Image: CE marking has been issued for a test to monitor levels of the fully human monoclonal antibody ustekinumab (Photo courtesy of Theradiag).
Image: CE marking has been issued for a test to monitor levels of the fully human monoclonal antibody ustekinumab (Photo courtesy of Theradiag).
A company specializing in theranostics and in vitro diagnostics took advantage of the 2015 AACC Annual Meeting & Clinical Lab Expo (Atlanta, GA, USA) venue to announce that it had obtained CE marking for its monitoring test for levels of the monoclonal antibody drug ustekinumab.

Ustekinumab (commercial name Stelara) was designed to interfere with the triggering of the body's inflammatory response through the suppression of the cytokines IL-12 and IL-23, which help activate certain T-cells. The antibody binds to the p-40 subunit of both IL-12 and IL-23 so that they subsequently cannot bind to their receptors. The drug is associated with several types of serious adverse effects. These include an increased risk of infection and the possibility of developing reversible swelling of the brain. More common side effects are upper respiratory infection, headache, and tiredness.

Theradiag (Marne La Vallee, France) is a company specializing in theranositics and diagnostics. Theranostics—a combination of the words therapeutics and diagnostics—is a proposed process of diagnostic therapy for individual patients to test them for the efficacy of taking a new medication and to tailor a treatment plan for them based on the test results.

Theradiag used the venue of the 2015 Annual AACC Meeting to announce that it had received CE marking for its ustekinumab monitoring test, the 10th biotherapy monitoring test in Theradiag’s LISA TRACKER range. The LISA TRACKER kits are rapid ELISA tests with common reagents and a three hour timeline.

“Theradiag is the only company in the world to offer such a large range of monitoring tests for the treatment of autoimmune and inflammatory diseases. To maintain our leadership on the market, we will develop monitoring kits for all available and future biotherapies in the fields of autoimmune diseases and cancer. The CE marking that we announce today, the 10th in our LISA TRACKER range, is a proof of this commitment,” said Michel Finance, CEO of Theradiag.

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