Bailey Bellaire – Senior Biomedical Engineer
Have you heard about the Syn-One Test™ from CND Life Sciences to help diagnose a synucleinopathy like Parkinson’s disease and have additional questions about how the tiny skin biopsies (three to be exact) will be processed? Perhaps you are a patient and your neurologist recently performed the skin biopsy procedure for the Syn-One Test and you are waiting for the results. If either scenario is the case, perhaps you have begun to wonder what actually happens to these biopsies once they are collected in the physician’s office? Let’s review the journey.
After a clinician anesthetizes the three recommended areas of the skin and obtains the necessary biopsies for the Syn-One Test, he or she will place each biopsy into a vial that contains a fixative solution (this is our specific preservation technique). The fixation process preserves biological material (your biopsies) as close to their natural state as possible, preventing decay and maintaining the microscopic intricacies and structures of the skin. The vials containing the biopsies and the supporting documentation are packaged in special return shipping materials and rapidly mailed to CND for processing.
Once FedEx hand-delivers the biopsies and documentation, CND immediately begins the process for the Syn-One Test. Upon arrival, patient information is recorded in our secure system, and the biopsies are assigned unique identifiers to remove the patient’s personal information. The biopsies are prepared for processing by first undergoing a thorough wash and cryoprotection. Cryoprotection prevents fluctuations in temperature from damaging the biopsies, further ensuring the biopsies will be of sufficient quality for testing. Once the cryoprotection process is complete, the biopsies are cut into ultra-thin sections by highly skilled laboratory engineers and technicians. These sections facilitate proper microscopic evaluation and visualization of pathology within epidermal and dermal (also referred to as cutaneous) nerve fibers and adjacent structures. Slides containing these thin specimen sections are submitted to quality control for review to ensure consistency, accuracy, and reliability. Upon favorable quality review, the test is advanced to a CND physician-pathologist for full evaluation under an advanced microscope.
The pathologist then thoroughly reviews each biopsy section, carefully inspecting it for abnormalities and pathological evidence of disease within the cutaneous nerve fibers. The primary focus of the Syn-One Test is to detect, visualize, and quantify the presence of an abnormal protein called phosphorylated alpha-synuclein. A positive result, which confirms the presence of the abnormal protein, would support the diagnosis of a synucleinopathy. Synucleinopathies include Parkinson’s disease (PD), dementia with Lewy bodies (DLB), multiple system atrophy (MSA), and pure autonomic failure (PAF).