FOR PATIENTS & CAREGIVERS

NERVE FIBERS IN YOUR SKIN CAN TELL A DEEPER STORY ABOUT YOUR HEALTH

Scientists have discovered that when a certain kind of abnormal protein appears in specific areas of your skin, it can be a sign of a central nervous system disorder. The good news: An advanced test using a simple skin biopsy taken at your doctor’s office can help provide the information needed to make the best decisions about your health.

Senior man

What are Synucleinopathies?

Neurodegenerative diseases are a group of progressive conditions that damage the nervous system and lead to disabilities over time. Most neurodegenerative disorders are linked to an accumulation of abnormal proteins within our nerve cells. Over time, these “bad” proteins cause a variety of problems for our normal body functions.  

Everyone has a useful protein in their body called synuclein (sin-NEW-klee-in), but sometimes it takes on a “folded” form, which can impair the way your central nervous system works. The family of neurodegenerative  diseases that can be detected by abnormal synuclein in nerve cells is called synucleinopathy.  

There are 4 distinct disorders within the synucleinopathy family:  

  • Parkinson’s disease (PD)  
  • Dementia with Lewy bodies (DLB) 
  • Multiple system atrophy (MSA) 
  • Pure autonomic failure (PAF) 

The prevalence of these disorders is increasing as our population ages. There are over 2 million people in the United States who have been diagnosed with a synucleinopathy and about 100,000 new cases are diagnosed every year.

That’s why researchers at CND Life Sciences (CND) have been working for more than 10 years to create the new Syn-One Test™ to detect abnormal synuclein in the nerve cells in your skin. We hold the doctor-patient relationship in highest regard and support the essential principle of shared decision-making when it comes to your health. The Syn-One Test is a new diagnostic tool that your doctor can order to help assess your specific medical condition and ultimately prescribe appropriate care.

Is the Syn-One Test Right for Me?

First, some helpful background on diagnostic tests for the central nervous system. 

In neurology, more than many other fields of medicine, there is a lack of clear and objective diagnostic tests to help confirm a given disease. For example, a spot on an MRI scan of the brain  could be evidence of a stroke or an autoimmune disease like multiple sclerosis, or it could be  entirely normal for that individual. This is very different than measuring blood glucose levels, for example, and being able to tell a patient that he or she has diabetes with 100% certainty.  

Therefore, the skill of a neurologist lies in the deep understanding gathered from a patient’s history and their neurologic exam. Laboratory, radiographic, and pathologic tests are then used as additional pieces of evidence to support or refute the presumed diagnosis. In many cases, the only time a neurologist can be certain that a diagnosis is correct is when a patient responds to treatment. This means that neurologists and their patients often manage decisions using incomplete diagnostic information and are left with the imperfect approach of monitoring signs and symptoms as they carry out a treatment plan 

testing

How is the Syn-One Test done?
Your doctor will numb your skin, take three (3) small biopsy samples, and cover the areas with a bandage. If your doctor does not typically perform biopsies, CND can help them get started. Your skin samples will be sent to a lab where medical pathology experts at CND will examine them. Your doctor will get the results in 2-3 weeks. 

microscope

What can the test tell me?
The test will tell your doctor if your skin has abnormal synuclein by visualizing the specific presence of the protein in your nerve fibers. The results can help your doctor determine if you have a synucleinopathy, which may be one of the four medical conditions mentioned above, with Parkinson’s disease being the most common of the four. 

paper icon

Why should I get tested?
If your doctor suspects you may have synucleinopathy, the results of the Syn-One Test, along with your health history and clinical features, can help provide a more confident diagnosis. The test results may even help shorten the time to a correct diagnosis –which means you and your doctor can get started on making the best choices for your health.  

questions icon

What to ask your doctor
It is important for you to discuss with your doctor if the Syn-One Test is an appropriate test for you.  

If your doctor has any questions about the test, he or she can 

  • Give us a call at (480) 569-2900 
  • Send us a note at info@cndlifesciences.com 
  • Visit us at www.cndlifesciences.com 

Biopsy Basics

To perform the Syn-One Test, your doctor would need to collect three small skin punch biopsies from you in their office. Your doctor can order a biopsy kit directly from CND.

Important points about the biopsies:

  • The biopsy procedure takes 10-20 minutes
  • Your doctor, nurse practitioner, or physician assistant will obtain the small skin biopsies from three locations: (a) back of your neck (b) just above your knee (c) just above your ankle
  • Those areas will first be numbed with lidocaine, which stings for about 10 seconds, but will allow the biopsies to be obtained without discomfort
  • A small instrument the size of a thin pencil is used to collect the skin samples from you; each sample is smaller than a typical pencil eraser
  • You should keep the area dry for 24 hours. You will receive band-aids to keep the biopsy areas covered for another 48 hours
  • There is no need for antibiotics
  • No stitches are required. The affected areas of the skin will form a small scab and then heal after about a month (although exact time varies by person)
  • You will be given post-biopsy instructions to take home with you
  • If you have any questions, you should consult your doctor’s office and they will guide your care

Insurance and Costs

CND is a Medicare and Tricare participating provider and has in-network contracts with a growing list of commercial health plans and other insurance carriers. Since health benefits may vary amongst programs and plans, CND’s billing team can assist in determining your specific benefits coverage before your physician orders the Syn-One Test and performs a skin biopsy. CND also offers self-pay options as needed for the uninsured and underinsured.

Online Self-Pay

Click below to make a payment to CND for laboratory services performed.

Make A Payment

Frequently Asked Questions

What is a synucleinopathy?

A synucleinopathy is a type of neurodegenerative disease that occurs when the abnormal form of a protein called alpha-synuclein accumulates in nerves within your body. Synucleinopathies include Parkinson’s disease, dementia with Lewy bodies, multiple system atrophy and pure autonomic failure

What causes synucleinopathy?

It is not clear why the abnormal form of a 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.

How is synucleinopathy diagnosed?

A synucleinopathy is most commonly diagnosed by a physician’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 physicians and patients confirm a diagnosis of synucleinopathy.

Why should I be tested for synucleinopathy?

Synucleinopathy testing provides important visual insights to your physician to aid in the diagnosis. Once diagnosed, your physician can recommend the appropriate therapy for you.

What is small fiber neuropathy (SFN)?

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.

What causes small fiber neuropathy (SFN)?

The exact cause of SFN is not always known. In some individuals, SFN can be caused by metabolic disorders such as diabetes, autoimmune diseases, genetic abnormalities, medication toxicity, and others.

How is small fiber neuropathy diagnosed?

SFN is diagnosed by examining a small skin biopsy 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 is then sent to a lab where it is processed so that the small nerves can be visualized and counted by highly qualified physicians. CND’s Syn-One Test includes the process for evaluating SFN.

Will the skin biopsy be painful?

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.

What does the Syn-One Test show?

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 physician describes the basic process that was used for the test, highlights the actual findings, and provides visual images of your nerve fibers. If the abnormal protein is detected, the test report will note this fact and confirm the likely diagnosis of a synucleinopathy. Your physician 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).

How will I receive my test results?

Test results are sent directly to your physician within three weeks of your biopsy procedure. CND cannot discuss individual test results with patients and all results must be discussed with your physician. Please remember to schedule a follow-up appointment with your physician to receive and review your results.

Will the Syn-One Test be covered by my insurance?

CND is a Medicare and Tricare participating provider and has in-network contracts with a growing list of commercial health plans and other insurance carriers. Since health benefits may vary amongst programs and plans, CND’s billing team can assist in determining your specific benefits coverage before your physician orders the Syn-One Test and performs a skin biopsy.  CND also offers self-pay options as needed for the uninsured and underinsured. 

How much will the Syn-One Test cost?

The net cost of the Syn-One Test and how much a patient may owe varies by each insurance plan depending on different factors. CND has a dedicated team that works with physician practices and patients prior to having the biopsy performed to determine the likely coverage of the Syn-One Test, and how much of the fee will be the responsibility of the patient.

When can I expect a bill for the patient portion of the Syn-One Test?

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

What happens if the Syn-One Test is not covered under my insurance?

CND will confirm your reimbursement status by conducting a pre-authorization 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 would then accept payment by credit card over the phone or through our website.

How is my “out-of-pocket” (OOP) obligation determined?

If you are submitting authorization for coverage to your insurance company, we offer personalized verification of insurance coverage. Typically, your 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 contracted rates, in addition to your personal insurance.

How do I speak to someone at CND Life Sciences for billing questions?

All billing-related questions should be directed to our Billing Department at 480-569-2902.

For Clinicians: Request a Syn-One Test™ Kit

The Syn-One Test provides objective pathological evidence to aid in the diagnosis of a synucleinopathy. Simply collect three small punch skin biopsies from your patient, send them to our CLIA-certified lab, and CND Life Sciences will provide important visual insights to support a diagnosis. If you are a clinician, click below to order a Syn-One Test Biopsy Kit.

Order a Kit