New Blood Test Measures Scleroderma Biomarker Linked to Gastrointestinal Issues and Pulmonary Hypertension

A new blood test measures autoantibodies called anti-vinculin, which have been found to be higher in scleroderma patients and have also been associated with gastrointestinal complications and pulmonary hypertension.

The test, called sclero-smart, was developed through a partnership with the Medically Associated Science and Technology (MAST) program at Cedars-Sinai Medical Center in Los Angeles, and is commercially available from Gemelli Biotech.

Vinculin is an intracellular cytoskeketal protein, present in many different types of tissues, that plays a role in cell structure and growth.

The prevalence of the most commonly measured autoantibody markers known to be associated with scleroderma — namely anti-centromere, anti-Scl-70, and anti-RNA-pol-III — ranges between 10% and 30%.

In contrast, up to 38% of scleroderma patients tested positive for autoantibodies against vinculin, according to an abstract published recently by the American College of Rheumatology, making these autoantibodies more prevalent than other biomarkers for scleroderma.

In addition, an association has been reported between the presence of anti-vinculin autoantibodies and gastrointestinal complications or pulmonary hypertension, suggesting that the new biomarker could help rheumatologists predict the risk of these conditions developing in scleroderma patients.

Scleroderma commonly affects the gastrointestinal tract of patients, therefore markers of GI complications are needed. In fact, researchers believe there is a link between scleroderma and the gut microbiome.

“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, executive director of the MAST program and co-founder of Gemelli Biotech, said in a press 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,” he added.

According to Gemelli, sclero-smart is the first and only commercially available test to measure the levels of anti-vinculin autoantibodies in the blood.

“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. As a potential catalyst for such a breakthrough, this test is an important development for helping patients with scleroderma,” said Matt Mitcho, CEO of Gemelli.