Amarantus BioScience has released preliminary data from a blood test for multiple sclerosis (MS) called the MSPrecise diagnostic. The company believes that the test could lead to more accurate diagnoses of MS early in the disease’s progression.
MSPrecise is a DNA sequencing test designed to identify specific DNA mutations that are associated with the immune system, and more specifically, a type of immune system cell known as a B cell. The assay is intended to identify patients with relapsing-remitting multiple sclerosis (RRMS).
MS is characterized by an autoimmune attack on myelin, the substance that insulates nerve cells, allowing them to conduct impulses and communicate. When immune cells damage myelin in the nervous system, MS symptoms result, including loss of movement, pain, vision loss and sensory problems.
Amarantus scientists recently tested the MSPrecise diagnostic by using cerebrospinal fluid (CSF) samples taken from people with MS. The test achieved a 86% sensitivity and 71% specificity to correctly identify early-stage RRMS. Sensitivity refers to the number of people with the condition correctly identified. Specificity refers to correct identification of people who do not have the condition. When combined with a different test, called an oligoclonal banding test (OCB), sensitivity was even better, at 96% and specificity improved to 83%.
On May 11, Amarantus Diagnostics reported findings obtained using blood samples from the same people with MS. The MSPrecise blood assay showed 81% sensitivity and 89% specificity for identifying early-stage RRMS. The results have not yet been combined with an OCB test.
“These early findings are encouraging, and provide a pathway to further define and refine the MSPrecise blood assay,” stated Colin Bier, Chief Development Officer of Amarantus Diagnostics. “Of particular importance, in this initial blood study, is the promising and positive analytical performance. There is such a high rate of misdiagnosis of MS, especially upon first clinical presentation of this chronic and extremely debilitating disease, that a blood test would be of great benefit to patients and physicians. We are preparing MSPrecise CSF for a CLIA-enabling validation study and, in parallel, will actively continue research and development of the MSPrecise blood assay.”
“MSPrecise is potentially a groundbreaking advancement for the diagnosis of multiple sclerosis. Based on the CSF validation data, we anticipate moving into a CLIA validation that is currently in the planning stages,” noted Gerald E. Commissiong, President & CEO of Amarantus BioScience Holdings, Inc. “The MSPrecise CSF assay, along with our LymPro Test® blood diagnostic for Alzheimer’s disease, are the two of key assets in our diagnostics division. Together, MSPrecise and LymPro will allow Amarantus Diagnostics to very rapidly achieve critical mass as one of the premier neurodiagnostic testing companies in the world.”
Early identification of RRMS could aid in treatments and possibly in preventation of myelin degeneration, hopefully slowing or even halting MS progression.