Precision Medicine: Biomarkers as an Objective Measure
Nov 29th, 2022
Multiple sclerosis is a complex condition, unpredictable and affecting every patient differently. Even though MS was first identified and described in medical literature more than 150 years ago, until recently, there has been a lack of reliable clinical, radiological or biological markers to measure disease activity and progression.
Neurologists typically employ a range of tools to diagnose and assess disease activity and progression in MS, including magnetic resonance imaging (MRI), cerebral spinal fluid analysis and rating scales, such as the Expanded Disability Status Scale (EDSS). Despite the available options for assessment, due to their limitations, there remains an unmet need for objective measurement tools that can sensitively measure and predict disease activity and progression. We need better tools.
One factor behind the compelling and critical need for better assessment tools is that, for the first time in MS history, an abundance of disease-modifying treatment options are available to patients. With more than 20 therapies with varying mechanisms of action, getting patients onto the right therapy for their MS as early as possible is the best way to guard against ongoing disease activity that can lead to accumulated disability.
Over the past decade, molecular biomarkers have gained traction across a range of diseases as a way for physicians and patients to better understand their conditions and responses to treatment through quantifiable data reflecting the patient’s individual biology. These biological molecules found in blood or other body fluids or tissues, signal the presence and severity of disease, help guide treatments and offer insights into how a patient is responding to treatment. In conditions such as diabetes or hypertension, biomarkers are tightly correlated to treatment outcomes.
MS experts recognize that MS patients need access to[LY1] biomarker data that offers MS-specific information related to ongoing disease activity, disability progression and treatment response to help guide their treatment decisions and disease management. However, they note that while there has been active research in this area, the validation and clinical use of biomarkers has been relatively limited.
While there are single biomarkers, such as NfL, GFAP, and others, that have been researched extensively in the field, not one is specific to nor can deliver a full understanding of one’s MS disease biology. Furthermore, a single biomarker only offers one indicator for a complex disease in which multiple factors are implicated within its pathology.
As Jonathan C. Calkwood, MD, states in an Expert Perspective, recently published in the American Journal of Managed Care, “one of the problems in MS is we’re managing the patient with a reactive approach.” In fact, current standards of care provide MS patients with testing options that only are able to offer data on damage that already has occurred.
There is a critical need to offer MS patients access to leading indicators. In fact, Dr. Calkwood goes on to note that the ideal biomarker would alert the doctor when a patient was not responding well to treatment so that therapy could be adjusted in advance of disease progression.
We at Octave couldn’t agree more with that perspective. Our clinically validated and in routine clinical use multivariate biomarker blood test is designed specifically for MS and leverages a panel of 18 proteins that are associated with four distinct disease pathways. The biomarker data informs an algorithm to determine the patient’s level of MS disease activity, providing them with an overall score. This score quantitatively measures the level of disease activity and can be used as an adjunct to help the neurologist identify patients who are not responding well to therapeutic interventions.
We are at the start of our journey to change MS management. As of now, we have presented results from more than 25 studies showing the impact of our work across our Precision Care Solution, with more studies being performed all the time. We are so excited to help bring this necessary tool to MS patients and their doctors as part of our Octave MS Precision Care Solution that includes MRI and clinical insights as well. Click here to see our studies performed to date and join us as we work toward a new standard of MS care, so patients can live more harmonious lives.