Best in blood

Unlike the current diagnostic tools, MSPrecise is a next-generation DNA sequencing assay, measuring DNA mutations found in rearranged immunoglobulin genes in immune cells (B cells) to identify patients with relapsing-remitting multiple sclerosis (RRMS) at first clinical presentation.

Gerald E. Commissiong, president and CEO of Amarantus, stated in a press release, “MSPrecise is potentially a groundbreaking advancement for the diagnosis of multiple sclerosis. Based on the CSF [cerebrospinal fluid] validation data, we anticipate moving into a CLIA validation that is currently in the planning stages.”

“The MSPrecise CSF assay, along with our LymPro Test blood diagnostic for Alzheimer’s disease, are two key assets in our diagnostics division,” he said. “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.”

Results from the most recent MSPrecise validation study using CSF samples for MS, as reported in January 2015, demonstrated an 86-percent sensitivity and 71-percent specificity in correctly identifying early-stage RRMS in subjects being evaluated for a demyelinating disease undergoing the current diagnostic standard of care (clinical evaluation, magnetic resonance imaging and oligoclonal banding tests), as adjudicated by an expert panel of physicians. When combined with oligoclonal banding (OCB) tests, sensitivity improved to 96 percent and specificity improved to 83 percent.

Amarantus Diagnostics, a wholly owned subsidiary of Amarantus BioScience Holdings Inc., reported May 11 preliminary MSPrecise blood assay results from the same study (collected concurrently with CSF from the same patients). In the study, preliminary results indicate that the MSPrecise blood assay exhibited an 81-percent sensitivity and 89-percent specificity for identifying early-stage RRMS in subjects being evaluated for a demyelinating disease undergoing the current diagnostic standard of care. These results have not yet been combined with OCB and will require replication prior to moving into a CLIA validation study.

“These early findings are encouraging and provide a pathway to further define and refine the MSPrecise blood assay,” Colin Bier, chief development officer of Amarantus Diagnostics, stated in a news release. “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.”

Bier tells DDNews that the blood-based version of MSPrecise diagnostic “provides a relatively simple means (blood sample) to diagnose MS as compared to lumbar puncture (collection of cerebrospinal fluid).” “The specificity of MSPrecise in conjunction with other diagnostic procedures will help rule out other potential neurodegenerative diseases which often complicates the definitive diagnosis,” he notes. “At the present time, diagnosis is based on the use of sophisticated imaging techniques which for the most part are primarily located within urban centers and, therefore, not easily accessible in rural areas.”

Amarantus’ long-term goal is “to make MSPrecise commercially available to all physicians as part of their workup of patients suspected of MS and ultimately to become the ‘gold standard’ for the diagnosis and differentiation from other neurodegenerative diseases and the ability to classify both the stage and form of the disease,” Bier says. “In addition, since the test is a simple blood test, it also permits the physician to monitor the patient’s progress and response to medication. This latter aspect is very important since different drugs act differently and failure to respond to one drug does not imply that the patient may not respond to another drug with a different mode of action.”