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Blood test for scleroderma, systemic sclerosis biomarkers launched
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Specialty biotechnology company Gemelli Biotech has announced the launch of a blood test that measures anti-vinculin levels to help physicians identify the risk of gastrointestinal or vascular complications among patients with scleroderma and systemic sclerosis, according to a press release.
The blood test, called Sclero-smart, will be the first and only commercially available test that measures levels of the autoantibody anti-vinculin, the company said. A recent study published by the American College of Rheumatology (ACR) showed that anti-vinculin is elevated in patients with scleroderma and is associated with gastrointestinal complications.
“We know from a substantial volume of research that bacterial infection in the gut can cause an autoimmune response that involves the abnormal production of anti-vinculin,” Mark Pimentel, MD, co-founder of Gemelli Biotech and executive director of the Medically Associated Science and Technology (MAST) program at Cedars-Sinai, said in the release. “The connection between anti-vinculin and scleroderma means that the gut microbiome could help us answer many of the questions we still have about diagnosing and treating scleroderma.”
Sclero-smart, an ELISA blood test, was developed through a partnership with the MAST program.
According to an abstract published by the ACR, 38% of patients with scleroderma tested positive for elevated levels of anti-vinculin antibodies. This suggests that anti-vinculin is more prevalent in scleroderma populations than any other biomarker currently used for testing, Gemelli said in the release. Further, the abstract noted that patients with scleroderma with elevated anti-vinculin levels experienced greater gastrointestinal symptom severity, an association no other marker provides.
Another ACR abstract found that anti-vinculin was also associated with pulmonary hypertension. According to Gemelli, few markers have an association with this serious vascular complication.
“Given how common the antibody appears to be in the patient population, this test could provide us with a more detailed understanding of the disease's underlying causes,” Matt Mitcho, CEO of Gemelli, said in the release. “As a potential catalyst for such a breakthrough, this test is an important development for helping patients with scleroderma.” – by Jason Laday