Protagen’s Diagnostic Test for Scleroderma, Multilisa BICD2, Receives CE Mark from EU

Protagen AG announced that Multilisa BICD2, its proprietary biomarker to diagnose scleroderma, has been given CE marking, meaning it meets all European Union (EU) requirements —safety, health, legal, and environmental — for a product available across the European Economic Area.

Most diagnostic tests look for the presence of specific antibodies in the blood. These are special immune system proteins that normally recognize invaders, such as viruses or bacteria, and mark them for destruction. The antibodies used in most diagnostic tests, however, are not always present in people with scleroderma.

Protagen’s Multilisa BICD2 test detects a molecule called BICD2 that is able to activate the immune system in scleroderma patients. BICD2 autoantibodies are found in about 30 percent of all systematic scleroderma (SSc) patients, and are highly associated with the limited form of SSc. This test, together with existing tools, increases the chances of properly diagnosing the condition.

BICD2 was discovered as a molecule associated with scleroderma through Protagen’s SeroTag technology platform. With the SeroTag technology, autoantibodies against several different molecules from blood samples from thousands of people can be measured spontaneously. The technology allows for the discovery of new biomarker candidates that can be used in tests to diagnose autoimmune diseases, such as scleroderma.

“The launch of the CE-marked Multilisa^® BICD2 underscores the high performance of the SeroTag^® platform in delivering novel biomarkers and diagnostic assays. We understand the high medical and diagnostic need for SSc, and that’s why we’ve chosen to target this disease with our first Dx (diagnostic) assay portfolio,” Dr. Stefan Müllner, CEO of Protagen, said in a company press release.

Scleroderma, also called systemic sclerosis or SSc, is an autoimmune disease of the connective tissue characterized by the hardening of the skin. In severe cases, the condition can also affect internal organs, such as the heart, blood vessels, kidneys, and lungs, and cause serious complications. The condition results from the body’s immune system attacking itself, but the underlying cause is not known.

There is currently no cure for scleroderma, but treatments to manage the condition exist, once it is properly diagnosed.