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Protagen Receives CE Mark for BICD2 Systemic Sclerosis Marker

NEW YORK (GenomeWeb) – Protagen said today that it has received the CE mark for its Multilisa BICD2 test for diagnosing systemic sclerosis, enabling the firm to market the test in the European Union and other countries that accept the CE mark.

The announcement follows the release last month of Protagen's CE-marked Multilisa CENP-B and Multilisa Scl70 assays, giving the company what CEO Stefan Müllner called "a comprehensive assay portfolio for the improvement of [systemic sclerosis] diagnosis and patient care."

Systemic sclerosis is an autoimmune disease that causes progressive fibrosis of the skin and internal organs. The BICD2, Scl70, and CENP-B autoantibodies are associated with disease progression and outcomes and as such can be used for clinical management of the condition.

BICD2 is the first proprietary biomarker discovered by Protagen using its SeroTag platform, which simultaneously measures autoantibody levels for thousands of antigens to detect expression patterns linked to disease. The company's diagnostic development strategy has been to identify such signatures and use them to detect disease and track a patient's response to particular therapies.

"The launch of the CE-marked Multilisa BICD2 underscores the high performance of the SeroTag platform in delivering novel biomarkers and diagnostic assays," Müllner said in a statement.