Over the past 20 years, several new treatments for multiple sclerosis have been approved. Unfortunately, though, diagnostics have not progressed alongside them.
A young company called DioGenix thinks it’s found a new way to identify MS patients sooner, enabling them to receive treatment sooner and potentially delay injury to the nervous system.
Its solution is a next-generation sequencing assay that measures changes in human immunity.
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To complete a validation study of its assay, the Bethesda, Md., company has just secured $3.2 million from new and existing investors including Nerveda LLC.
Currently the study has enrolled more than 200 subjects at 13 sites, President and CEO Larry Tiffany said, and enrollment should be complete in early 2014. What DioGenix is studying is cerebral spinal fluid and blood samples collected from individuals being evaluated for some kind of immune-mediated neurological disorder that may or may not be MS.
The problem is that the underlying cause of MS is not clear, although scientists know that it’s characterized by inflammation in the central nervous system triggered by an autoimmune response. It’s a chronic condition that can lead to blurred vision, poor coordination, slurred speech, numbness and paralysis.
Because MS shares symptoms and characteristics with other neurological diseases, doctors perform an extensive workup that includes physical examinations, MRI, blood tests and a cerebral spinal fluid analysis, to determine what might be the cause.
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The DioGenix diagnostic, called MSPrecise, takes the current cerebral spinal fluid test a step further. The lab-based tests looks for gene mutations in certain spots within the B-cell genome that research has suggested are driven specifically by MS. That could help doctors distinguish MS from other immune-mediated diseases that share similar biological features, and may also help them identify more aggressive cases, Tiffany said.
Although treatment of MS has advanced over the last several decades, diagnostics have not, Tiffany said. Treatments that emerged in the 1990s were relatively safe and inexpensive, he explained. “During this evolution on the therapeutic side, doctors became more comfortable saying, ‘let’s put a patient on therapy if we think they have the disease.'”
But a new wave of drugs has come onto the market over the past few years — drugs that Tiffany said provide great benefits to patients but are more expensive and carry more concerning safety profiles. “What we see is a real opportunity to continue to get the right patients on these therapies as early as possible but to make sure we’re not putting patients without the disease on these drugs,” he said.
With the additional funding, DioGenix should be able to complete the study, publish the results, expand its lab and go through the CLIA licensure process. Initially, it won’t need FDA clearance, since the tests will be conducted in the lab. “We’ve run (the trial) with an eye to prepare the data to meet all the regulatory endpoints so that someday we could actually provide this data as part of a regulatory filing,” Tiffany added.
Meanwhile, the company is also collecting blood samples that it will examine to see if the same DNA mutation signature found in patients with MS is also found in blood. The hope is that the company could create follow-on products that use more accessible fluid samples, like blood or urine.
The company also sees potential for its test to be used as a monitoring tool for pharmaceutical companies developing and testing MS drugs.
DioGenix’s technology was licensed from University of Texas Southwestern Medical Center and initially developed as a subsidiary of Ore Pharmaceuticals.
[Image credit: BigStock Photos]
