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.
Its diagnosis may involve a physical examination to check for clinical symptoms and a test to look for autoantibodies in the blood.
The majority of patients with scleroderma test positive for antinuclear autoantibodies. They are called “antinuclear” because they attack the nucleus (center) of the cells. One such type of autoantibody is directed against RNA polymerase III, a protein responsible for synthesizing different types of RNA molecules.
RNA polymerase III autoantibodies can be used as markers for scleroderma, or systemic sclerosis (SSc). They may help not only in diagnosing, but also in predicting, how the disease may progress. Moreover, up to 70% of patients who are positive for RNA polymerase III autoantibodies may test negative for other autoantibodies linked to SSc.
The new blood tests are part of the company’s portfolio of automated EliA tests to aid in diagnosing connective tissue diseases. According to the company, the EliA RNA polymerase III test is the first fully automated RNA polymerase III test available in the U.S.
The other blood test looks for the presence of autoantibodies against ribosomal P, a protein in ribosomes. A ribosome is a structure inside cells where proteins are built up from their basic building blocks.
Ribosomal P autoantibodies are found in the blood of some patients with SLE, the most common type of lupus, a disease that causes inflammation in the connective tissue.
“The addition of RNA polymerase III and ribosomal P to the EliA connective tissue disease test menu will add considerable value to the diagnosis of SSc and SLE,” Homburger, also is a professor emeritus of laboratory medicine at Mayo Clinic College of Medicine, said.
The company hopes that the new blood tests for connective tissue diseases help provide an accurate diagnosis, allowing patients to receive the most adequate treatment sooner.
They “have been designed to improve the differentiation of SSc and SLE from other connective tissue diseases. Targeting existing diagnostic care gaps can potentially lead to earlier and more accurate diagnosis and ultimately improve clinical outcomes for patients,” Homburger said.
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