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 procedure at your doctor’s office can help provide the information needed to make the best decisions about your health.
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 5 distinct disorders within the synucleinopathy family:
- Parkinson’s disease (PD)
- Dementia with Lewy bodies (DLB)
- Multiple system atrophy (MSA)
- Pure autonomic failure (PAF)
- REM sleep behavior disorder (RBD)
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 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.
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 about 3 weeks.
What can the test tell me?
The results can help your doctor determine if you have a synucleinopathy, which may be one of the five medical conditions mentioned above, with Parkinson’s disease being the most common of the five.
Why should I get tested?
If your doctor suspects you may have a 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.
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 email@example.com
- Visit us at www.cndlifesciences.com
Patient Matters Video Series
You might be wondering what it’s like to get the Syn-One Test or how it may be able to help you.
In this video series, hosted by former CNN anchor Daryn Kagan, real patients share their experiences and explain how the Syn-One Test helped them get critical answers about their health.
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
- *To ensure maximum sensitivity and accuracy, CND recommends the collection of three (3) skin biopsy samples from three (3) distinct anatomical locations taken during one patient visit. This protocol is supported by the medical literature. However, the number of biopsy samples collected is at the sole discretion of the ordering clinician. CND only bills for the number of biopsy samples provided according to the allowable billing units for each relevant billing code.
Insurance and Costs
CND Life Sciences is a Medicare and Tricare participating provider and is working 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 the expected benefits coverage for your patients before you conduct the required skin biopsies for the Syn-One Test. CND also offers self-pay options and payment plans for your uninsured and underinsured patients as needed.
Frequently Asked Questions
Synucleinopathies include Parkinson’s disease, dementia with Lewy bodies, multiple system atrophy, pure autonomic failure, and REM sleep behavior disorder.
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.
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.
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.
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 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.
Small fiber neuropathy 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 small fiber neuropathy.
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 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).
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.
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 the expected benefits coverage for your patients before you conduct the required skin biopsies for the Syn-One Test. CND also offers self-pay options and payment plans for your uninsured and underinsured patients as needed.
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.
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.
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.
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.
All billing-related questions should be directed to our Billing Department at 480-569-2900.
The Syn-One Test is classified as a “laboratory developed test” or an “LDT” and does not require review and approval by the FDA. 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) which regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA).