Research by the UB Department of Medicine’s Julian Ambrus and Long Shen has resulted in a new test for early diagnosis of one of the most prevalent autoimmune disorders.

Researchers Awarded Patent for Sjogren’s Syndrome Test

Published November 13, 2014

Researchers in the University at Buffalo’s Department of Medicine have been awarded a patent for a test that allows physicians to diagnose the autoimmune disease Sjogren’s syndrome earlier than ever before.

The new biomarker-based test means that people with Sjogren’s disease — characterized by painfully dry eyes and mouth — can receive treatment when they’re more likely to benefit from it.

The new biomarker-based test means that people with the condition — characterized by painfully dry eyes and mouth — can receive treatment when they’re more likely to benefit from it.

It grew out of breakthrough research led by Julian L. Ambrus Jr., MD, associate professor of medicine, and Long Shen, research assistant professor.

Test Developed from Discovery of Novel Antibodies

In 2012, the UB researchers reported that they’d discovered novel antibodies in 45 percent of patients who met most of the clinical criteria for Sjogren’s syndrome except the two antibodies typically required for a diagnosis.

These two antibodies — called “Ro” and “La” — appear late in the disease.

The team found at least one of the new antibodies in 76 percent of patients with symptoms lasting less than two years, but without the Ro and La antibodies.

Their findings were published as a highlighted article in the journal Clinical Immunology with an editorial by Robert I. Fox, MD, considered one of the world’s top Sjogren’s scientists.

More recently, Ambrus and Shen reproduced their findings in a study conducted with colleagues from the National University of Athens, Greece.

These findings were published in August, also in Clinical Immunology.

Late Diagnosis, Little Relief for Patients

Although Sjogren’s syndrome is one of the three most common autoimmune diseases, it is not well known.

The condition often takes years to diagnose, according to Ambrus.

 “Sjogren’s patients get diagnosed too late,” he says, noting that 90 percent of patients are women.

“They go to the doctor because their eyes are dry or they can’t swallow, but by that time, their salivary or tear glands are already dead. They’re way past the point where they can generally benefit from treatment.”

In addition to the chronic pain resulting from an inability to produce tears or saliva, patients often cannot taste anything and have serious tooth decay.

The condition is also associated with mild kidney and lung disease. Five to 10 percent of people with Sjogren’s syndrome develop lymphoma.

Research Resulted in Animal Model Used Globally

The discovery of the novel Sjogren’s antibodies grew out of a collaboration between UB and the locally based company Immco Diagnostics that in 2006 resulted in a superior animal model for the syndrome that’s used in labs worldwide.

“Our animal model has completely changed how people think about this disease,” Ambrus says.

“Sjogren’s disease in our animal model marches along in exactly the same way that the human disease does, reproducing every stage of the disease.”

Once scientists detected the new antibodies in mice, they started testing patients at Buffalo General Medical Center, finding the same antibodies, even at early stages of the disease.

Locally Developed Test, International Impact

UB has licensed the technology for its biomarker-based test to Immco, which develops autoimmune disease diagnostics and reagents.

Scientists there created a diagnostic tool based on the research that has significant proprietary value.

Because Sjogren’s syndrome presents with various symptoms, the test will be marketed to several different types of physicians, including oral surgeons, ophthalmologists, rheumatologists and dentists.

 “This is a very good example of how research and industry collaborate to produce something that will bring a lot of good to the health care industry—and it’s happening here in Buffalo,” says Immco CEO William Maggio.