A synucleinopathy is a neurodegenerative disorder primarily characterized by abnormal deposition of misfolded alpha-synuclein protein in neurons and glial cells, which can then affect normal nervous system function. Synucleinopathies include Parkinson’s disease, dementia with Lewy bodies, multiple system atrophy, and pure autonomic failure. RBD is considered a prodromal synucleinopathy. Ongoing research is being conducted in patients with RBD.

It is not clear why the abnormal form of a naturally occurring protein called alpha-synuclein accumulates in nerve cells of certain individuals (and not in others). However, it is understood that the presence of abnormal alpha-synuclein in nerve cells results in gradual deterioration of important nervous system functions. 

A synucleinopathy is most commonly diagnosed by a clinician’s evaluation of a patient’s clinical features and history, as there have been very limited diagnostic tests available to demonstrate more definitive, pathological evidence of disease. CND’s introduction of the Syn-One Test represents a major milestone in helping clinicians and patients confirm a diagnosis of a synucleinopathy by examining small skin biopsies in a pathology lab. This biopsy collection procedure only takes a few minutes and involves taking a small circular piece of tissue (3 mm in diameter) from the surface of the skin. Before the skin is removed, a local anesthetic (Lidocaine) is used to numb the area. The piece of skin is small enough that no stitches are required, and it will heal on its own. The skin specimen is then sent to a lab where it is processed to detect and visualize the accumulation of the abnormal alpha-synuclein protein within nerve fibers of your skin. 

Synucleinopathy testing provides important visual insights to your clinician to aid in the diagnosis. Once diagnosed, your clinician can discuss a treatment approach with you. 

The human body contains nerves of various sizes, ranging from small fibers that can sense pain, pressure, and temperature to large fibers that assist in our sense of balance. When the small, unmyelinated nerve fibers that convey temperature and pain are damaged, small fiber neuropathy (SFN) develops. Damage to the small nerve fibers can result in the experience of pain, numbness, burning, and other abnormal sensations. 

The exact cause of small fiber neuropathy is not always known. In some individuals, small fiber neuropathy can be caused by metabolic disorders such as diabetes, autoimmune diseases, genetic abnormalities, medication toxicity, and others. Small fiber neuropathy may also be associated with synucleinopathies. 

Small fiber neuropathy is diagnosed by examining small skin biopsies in a pathology lab. This biopsy collection procedure only takes a few minutes and involves taking a small circular piece of tissue (3 mm in diameter) from the surface of the skin. Before the skin is removed, a local anesthetic (Lidocaine) is used to numb the area. The piece of skin is small enough that no stitches are required, and it will heal on its own. The skin specimen is then sent to a lab where it is processed so that the small nerves can be visualized and counted by highly qualified pathologists. CND’s Syn-One Test includes the process for evaluating small fiber neuropathy in addition to the detection of abnormal alpha-synuclein, so only one set of biopsies is taken for both assessments. 

A small–punch skin biopsy is considered a minimally invasive procedure with relatively limited pain reported by patients. A local anesthetic (Lidocaine) is applied to numb the area prior to biopsy procedure, and this may cause up to 10 seconds of discomfort. 

The Syn-One Test for synucleinopathy detects and visualizes the accumulation of an abnormal protein within nerve fibers of your skin. The test report sent to your clinician describes the basic process that was used for the test, highlights the actual findings, and provides visual images of nerve fibers. If the abnormal protein is detected, the test report will note this fact and confirm the likely diagnosis of a synucleinopathy. Your clinician would then review your clinical features and history, along with the Syn-One Test results, to determine a more specific diagnosis (e.g., Parkinson’s disease). 

Test results are sent directly to your clinician. CND does not discuss individual test results with patients and all results must be discussed with your clinician. Please remember to schedule a follow-up appointment with your clinician to discuss your results. 

CND Life Sciences is a Medicare and Tricare participating provider and is working diligently to establish in-network contracts with commercial payers, given our strong and increasing body of scientific and clinical utility evidence. Since health benefits vary with different programs and plans, CND’s Patient Access team can help determine your expected benefits coverage before you schedule the required skin biopsies for the Syn-One Test. CND also offers self-pay options and payment plans for uninsured and underinsured patients as needed. Contact the Patient Access team at patientaccess@cndlifesciences.com or call 480-569-2900 ext. 2. 

The net cost of the Syn-One Test and patient’s financial responsibility varies by each insurance plan, depending on different factors. Before the skin biopsy is performed, the CND Patient Access team works with clinician practices and patients to determine the likely coverage of the Syn-One Test and how much of the fee is the patient’s responsibility. 

Please note that patients might be billed a facility charge; these charges are up to the facility and CND would not be able to provide this estimate for patients. Patients should check with the clinician and/or the facility where the skin biopsy is being performed for further details on these potential charges. 

If you are responsible for any costs, you should receive a bill within 90 days of when the biopsy was performed. However, certain billing processes may take longer depending on the type of insurance you have. 

CND will confirm your reimbursement status by conducting a verification of your insurance benefits. If limited or no coverage exists, CND may be able to offer a “Patient Prompt Pay” option for you before the test is run.  CND offers self-pay options. Payment can be made on our website here. Also, CND accepts Care Credit and participates in several of their program options, some of which may align with your financial needs. 

If you are submitting authorization to your insurance company, we offer personalized verification of insurance coverage. Typically, your “out of pocket” (OOP) is the deductible, co-pay, or co-insurance amount as indicated by your health plan. CND will provide you with an estimate of the patient responsibility to the specific insurer’s reimbursement rates, in addition to your personal insurance.  

Please note that patients may be billed a facility charge depending on the location of testing; these charges are completely up to the facility and CND would not be able to provide this estimate for patients. Patients should check with the clinician and/or the facility where the skin biopsy is being performed for further details on these potential charges. 

All billing-related questions should be directed to our Patient Access team at 480-569-2900, ext. 2. 

The Syn-One Test is a “laboratory developed test” or an “LDT.”  As an LDT, the Syn-One Test can be used by clinicians for patient care and is governed by The Centers for Medicare & Medicaid Services (CMS) through the Clinical Laboratory Improvement Amendments (CLIA) program. The CLIA program regulates laboratories to ensure accurate and reliable test results when testing is performed on patient specimens. CND’s pathology lab that provides the Syn-One Test to customers is CLIA certified and has met all applicable CLIA requirements.