FDA Clears Thermo Fisher’s Tests for Scleroderma, Lupus Diagnosis

The U.S. Food and Drug Administration (FDA) has cleared Thermo Fisher Scientific to market its blood tests for diagnosing scleroderma and systemic lupus erythematosus (SLE), two autoimmune diseases.
“Autoimmune diseases can be a challenge to diagnose. Reliable and accurate laboratory tests that provide clinical clarity are essential tools for clinicians managing these patients,” Henry Homburger, MD, who directs Thermo Fisher’s Phadia Immunology Reference Laboratory, said in a press release.

Scleroderma is caused by an overactive immune system that makes autoantibodies that mistakenly attack the body’s own tissues. This causes inflammation that can damage the skin and the connective tissue that support and give structure to other tissues in the body.

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