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Blood-Based MS Diagnostic Shows Promise in Fulfilling Unmet Need
The complex nature and automimmune features of MS make it an ideal lead product opportunity for DGx. MS attacks the central nervous system through demyelination of nerves in the brain and spinal cord, leading to a chronic debilitating state that, for many patients, requires regular drug injections that help manage, but do not cure the disease. In the United States alone, there are approximately 400,000-500,000 individuals stricken by MS with up to 30,000 new cases diagnosed each year. Although, it constitutes only 15% of the worldwide MS incidence and prevalence, DGx believes the U.S. market for a new MS Diagnostic/Risk Assessment Assay will comprise the estimated 40,000-60,000 patients who must annually undergo a spinal tap to obtain cerebral spinal fluid (CSF) as part of the current diagnostic process and the estimated 100,000-150,000 patients who annually undergo diagnostic MRIs. This does not take into account the growth potential within the market, considering that many patients currently forego testing or choose not to be regularly re-tested due to the inconclusive and invasive current standard of care.
DGx has shown that a reliable, multivariate signal is detectable in the blood of patients with MS. This multivariate signal is driven by the complex pathology associated with the inflammatory and autoimmune features of MS, which is why current CSF- and image-based diagnostics are inconclusive and therefore unable to provide definitive results to clinicians. This lack of diagnostic certainty creates inefficiencies in the clinic as multiple diagnostic tests are required over months or even years increasing the anxiety for patients while driving up total healthcare costs. These factors result in a current U.S. MS diagnostic market exceeding $250M per year. A more reliable, non-invasive test would quickly gain market share but also catalyze growth in the market as adoption of a battery of blood-based MS tests would spread from the neurological specialist to the community neurologist to the general practitioner.
DGx’s lead program is on an accelerated development path highlighted by the recent completion of an expanded clinical study on 140 subjects. Results from this study have allowed DGx to identify and patent a highly correlative 7-gene diagnostic marker set which is 99% sensitive and specific for the detection of early-stage MS patients.
