About 400,000 Americans have multiple sclerosis, a chronic central nervous system disease that can cause blurred vision, poor coordination, slurred speech, numbness and paralysis, among other things.
Despite the serious symptoms, diagnosis is often tricky because symptoms vary and can be hard for physicians to interpret. Gaithersburg, Maryland company DioGenix Inc. started up in 2008 to commercialize work on a lab test that could improve the diagnostic process.
Now, to fund a 150-patient clinical trial that has just begun enrolling, DioGenix has completed a $1.5 million Series B from existing investors including life science seed fund Nerveda LLC. The trial will validate its test, MS Precise, for early identification and diagnosis of multiple sclerosis.
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Multiple sclerosis is characterized by scarring of the myelin sheath in nerve cells that disrupts the transmission of messages from the brain and causes inflammation. Because MS signs and symptoms are also characteristic of other nervous system disorders, the disease is typically diagnosed through a deductive process that includes medical history, physical exams, an MRI and analysis of spinal fluid.
The analysis of spinal fluid typically looks for evidence of general inflammation that’s not seen in the blood, DioGenix CEO Larry Tiffany said. But even that can’t give a definitive diagnosis and produces false positives. According to the Multiple Sclerosis Foundation, diagnosis is correct 90-95 percent of the time.
DioGenix’s lab test takes the cerebral spinal fluid test a step further, looking for gene mutations in certain spots within the B-cell genome that research has suggested are driven specifically by MS. Tiffany said the team thinks the specificity of the test could help clinicians distinguish MS from other immune-mediated neurological diseases that share similar biological features. It may also someday be able to help physicians identify more aggressive cases of MS.
In a recent study, the test outperformed the current method of analysis in patients suspected of having MS, according to the company. A more confident diagnosis would hopefully lead to better use of prescription of MS drugs, which suppress or alter the immune system and shouldn’t be used by people without the condition.
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DioGenix’s test is an extension of the work of Dr. Nancy Monson’s team at the University of Texas Southwestern Medical Center. A blood test based on the same technology is also in development.
[Multiple sclerosis photo from BigStockPhotos]
