A new study testing Amarantus Diagnostics’ MSPrecise on multiple sclerosis patients identified the test as a specific and sensitive diagnostic test for multiple sclerosis. The test accurately diagnosed 84% of multiple sclerosis patients from a broad range of subjects with potential neurological diseases. These results further support Amarantus Diagnostics’ ability to design next generation sequencing (NGS) molecular diagnostics to test for disease.
“MSPrecise scoring is a powerful approach to aid clinicians in this task,” said Colin Bier, Chief Development Officer of Amarantus Diagnostics, in information provided to Multiple Sclerosis News Today. “In this study completed in 2013 and now reported in ‘GENE,’ there is an overall MSPrecise accuracy of 84% in identifying relapsing-remitting multiple sclerosis (RRMS) patients or patients that will develop RRMS, which represents a huge benefit to physicians.”
The study, “MSPrecise: A Molecular Diagnostic Test for Multiple Sclerosis Using Next Generation Sequencing,” was published in the journal Gene. Initiating the study, researchers at UT Southwestern Medical Center, UMass Memorial Medical Center, John Hopkins University, and DioGenix Inc. were interested in testing the accuracy of MSPrecise. This test uses samples of cerebrospinal fluid to analyze mutations in the VH4 gene of B-cells. B-cells have been shown to accumulate VH4 gene mutations in patients with the early stages of RRMS. The number of specific replacement mutations can be quantified to “score” the patient for the likelihood of developing or converting to RRMS, giving clinicians another tool in their toolbox for diagnosing multiple sclerosis.
“Given the early misdiagnoses that often occur with multiple sclerosis, physicians have an increasing need for new methods to accurately diagnose their patients,” said Bier. In the study, the researchers obtained cerebrospinal fluid cell pellets from 26 patients with an undiagnosed neurological disease and 13 patients with confirmed RRMS. When the researchers used MSPrecise to amplify VH4 gene segments, they were able to predict RRMS with a sensitivity of 75% and a specificity of 88% in the undiagnosed patients and an accuracy of 84% in the RRMS patients.
Amarantus is continuing to develop the ability to diagnose RRMS and has a blood-based version of MSPrecise in the works. The company also conducted a study that showed additional features for MSPrecise that increase the accuracy of the test. “In early 2015, Amarantus reported data from a later study that showed a significant increase in the accuracy of MSPrecise when adding oligoclonal banding (OCB) to the algorithm,” said Bier. “We intend to publish those data combining MSPrecise and OCB in the near future.”
In addition, Amarantus will continue to validate the current iteration of MSPrecise. “Our immediate focus is to conduct a CLIA-validation study in order to make the test commercially available, and plans are being finalized in this regard,” said Gerald E. Commissiong, President & CEO of Amarantus Bioscience Holdings. “We also plan to conduct future investigational studies to determine whether MSPrecise scoring using NGS platforms may be utilized to identify clinically isolated syndrome (CIS) patients who will convert to RRMS. Additionally, a more expansive clinical study with a larger patient cohort including several sub-cohorts of RRMS patients on disease modifying therapies and OND patients is also planned.”
According to Amarantus, “MSPrecise would augment the current standard of care for the diagnosis of multiple sclerosis by providing a more accurate assessment of a patient’s immune response to a challenge within the central nervous system.” Amarantus also hopes to use NGS to discern between individuals who may develop progressive multiple sclerosis, increasing the population of patients the company helps.