April 2, 2020 — Phoenix, AZ — CND Life Sciences, an innovative medical technology company pioneering the detection, visualization, and quantification of protein deposition in cutaneous nerve fibers, has introduced the first commercially available test of its kind to aid physicians in the diagnosis and treatment of neurodegenerative diseases. The company’s Syn One Test™ offers physicians and patients an accurate, evidence-based tool to increase clarity and confidence in diagnostic assessment and overall care planning.
The Syn-One Test leverages a decade of science and carefully honed laboratory techniques to identify the presence of an abnormal form of a specific protein known as alpha-synuclein. By obtaining three small punch skin biopsies performed in office by the patient’s clinician, CND applies specialized staining and analysis to detect folded, phosphorylated alpha-synuclein in dermal layers of the skin. This abnormal form, commonly referred to as “p-syn”, is a well-known biomarker for a family of diseases called synucleinopathies, the most prominent disorder being Parkinson’s disease. A physician ordering Syn One receives a detailed report of the pathologic findings of the test, including visual images of CND’s assessment and positive-negative determination of the presence of p-syn. Syn-One is supported by well-established pathology reimbursement codes and has been covered by Medicare and a growing number of private health insurance plans.
“Finally, science and technology have made it possible to develop and offer a reliable, objective tool to help neurologists and their patients confirm critical diagnoses of neurodegenerative diseases like Parkinson’s and Lewy body dementia,” says Todd Levine, MD, the medical director and founder of CND Life Sciences. “The Syn-One Test was designed to be a convenient option for neurologists and their patients to access visual evidence and additional insights for important diagnostic and therapeutic decision-making.”
Each year, there are nearly 100,000 new diagnoses of synucleinopathies in the US including 60,000 new cases of Parkinson’s disease. At the same time, there are an estimated 80,000 new cases of essential tremor annually in the US, a condition that may resemble a synucleinopathy but has a very different clinical pathway and prognosis. Published studies have suggested that even the most experienced neurologists specializing in movement disorders have challenges making positive diagnoses of synucleinopathies in 30% of cases early in the disease course.
“CND’s mission is to continue innovating, including partnering with researchers, clinicians and biopharmaceutical companies to develop diagnostic tools that are essential precursors to personalized treatment for patients,” adds Levine. “As the field of neurodegenerative disease evolves and new therapies become available, we intend to be a reliable collaborator and provider of meaningful solutions.”