A team of researchers from around the country have published findings indicating the accuracy of MSPrecise® (Amarantus Bioscience Holdings, Inc.), a laboratory test under development for diagnosing MS. The study was funded by the Society, the National Institutes of Health, the Burroughs Wellcome Fund and DioGenix, Inc. (since acquired by Amarantus). Previous work on MSPrecise was funded by the National MS Society through its commercial research arm, Fast Forward. William Rounds and Nancy Monson, PhD (University of Texas Southwestern Medical Center, Dallas) and colleagues report these findings in Gene (Early online publication, July 11, 2015). Further research will be needed to determine the value of MSPrecise as an aid to diagnosing MS.
Background: Right now, there are no symptoms, physical findings or laboratory tests that can, by themselves, determine if a person has MS. Several strategies are used to determine if a person meets criteria for a diagnosis of MS, and to rule out other possible causes of whatever symptoms the person is experiencing.
Amarantus is using a unique approach that may provide an earlier and more confident diagnosis of MS based on the pioneering work of Dr. Monson and colleagues. Dr. Monson’s team demonstrated that patterns of variations in certain genes in immune B cells that encode important immune system proteins differ in people with MS as compared to people with other neurological diseases. Using this insight, Dr. Monson and her team developed a DNA mutation “signature” for MS. Data suggest that a numerical score based on this signature might be used to identify people with relapsing-remitting MS early in the disease course. DioGenix worked with Dr. Monson to expand her research and develop a molecular test, MSPrecise®, that utilizes cutting-edge next-generation DNA sequencing to more accurately measure this signature, by providing a very rich database of DNA mutations on each patient.
To date, this research has involved, primarily, analysis of spinal fluid (CSF). The Society’s commercial arm, Fast Forward, partnered with DioGenix to use its novel approach in developing a blood-based MS diagnostic test. Amarantus is continuing efforts to develop this blood test. The current study was designed to explore the accuracy of the CSF-based test in distinguishing people with MS from people with other neurologic diseases.
The Study: The team analyzed B cells taken from the spinal fluid of 13 people with definite or possible relapsing-remitting MS, and 26 people with other neurologic diseases. One person with MS had levels of B cells that were too low to assess the DNA patterns. Of people with other diseases, 23 either did not show the DNA signature or had low levels of B cells. Overall, MSPrecise showed 84% accuracy in identifying people who had or would develop relapsing-remitting MS.
Comment: Additional research will be needed to fully determine the value of MSPrecise as an aid to diagnosing MS. In a July 29 press release, Amarantus notes plans to complete validation studies necessary to make this test commercially available, as well as future studies to determine the usefulness of MSPrecise in identifying people at high risk for MS who will develop MS, and to determine its accuracy in larger groups of people with relapsing-remitting MS.
“We look forward to seeing further data on MSPrecise, and hope that it proves to be a useful tool for the diagnosis and management of MS,” notes Mark Allegretta, PhD, Associate Vice President, Commercial Research, for the National MS Society. “Accelerating research breakthroughs – such as the development of clinical laboratory tests that may improve MS diagnosis and predict response to therapy – requires collaborations that break down the barriers to commercial investment.”
Read more about how the Society drives commercial progress in MS research
Read more about how MS is diagnosed
MSPrecise is a registered trademark of DioGenix.