Researchers are set to begin clinical trials of a blood test that can easily distinguish between severe multiple sclerosis (MS) and a benign form of the disease.

Up to 25 percent of those diagnosed with MS have a benign form of the disease and may be in remission for ten years or more. But because there is no way to identify benign MS in the early stages, those patients needlessly take medications and experience anxiety for years. Conversely, identifying those with severe MS means that they could receive aggressive treatment at the outset.

“What is needed is an inexpensive, easily obtained barometer for monitoring disease activity in these patients,” says Stuart Cook, professor of neuroscience at the University of Medicine and Dentistry of New Jersey and the trial's lead investigator. Most methods are either too expensive or not sensitive enough, he says.

What is needed is an inexpensive, easily obtained barometer for monitoring disease activity., Stuart Cook, University of Medicine and Dentistry of New Jersey

The test, developed by Israeli company Glycominds, is based on glycans—the sugars found inside and on the surface of human cells—which play a crucial role in autoimmune and inflammatory diseases. Using the company's library of glycans, the researchers identified an antibody to a certain glycan that is elevated in the cells of people with MS and determined its level in more than 200 patients. “We proved that we have a specific marker [for MS severity] based on the level of [specific] antibodies on these specific sugars,” says Glycominds chief executive Avinoam Dukler.

The claim will be tested in 385 people at 80 centers across the US, Canada and Israel and is the largest trial of patients with 'clinically isolated syndrome'—in which they exhibit the first signs of MS and magnetic resonance imaging indicates they have a high possibility of MS—who have not begun treatment.

Participants will not receive any treatment for six months. “We will predict from taking their blood at the first presentation whether there will be a second presentation within six months,” says Dukler. Participants will then be monitored for a further eighteen months, with blood taken every six months.

An accurate test could be invaluable to MS patients, but researchers must proceed carefully, says Jack Burks, chief medical officer of the Multiple Sclerosis Association of America. If the test wrongly diagnoses patients as having only benign disease, for instance, they would miss the necessary treatment, he notes. “The brain cells they lose by foregoing treatment are lost forever.”

If the blood test proves accurate at the first six-month point, a product could be on the market as early as 2006. Glycominds is also working on a glycan-based test for distinguishing between Crohn's disease, ulcerative colitis and irritable bowel syndrome.