FOR CLINICIANS

BRINGING A NEW DIAGNOSTIC PARADIGM TO NEUROLOGISTS AND OTHER CLINICIANS

CND Life Sciences is dedicated to supporting the care of patients who present with signs and symptoms suggestive of neurodegenerative disease.

Doctor explaining chart

Clinical Overview

CND was founded by practicing neurologists who understand the importance of arming physicians and their care teams with key information and evidence to support diagnostic and therapeutic decision-making.

The need for an objective diagnostic tool
Rendering a definitive diagnosis of a given neurodegenerative condition is not always easy.

  • Recent studies have shown that even in the hands of the best movement disorder specialists, patients diagnosed with Parkinson’s disease who come to autopsy show no evidence of Lewy bodies and have an alternate diagnosis 30% of the time
  • Interestingly, similar data exist for patients with multiple sclerosis, Alzheimer’s disease, and immune-mediated neuropathies
  • This data informs us that clinical diagnostic skills cannot always accurately distinguish the varied forms of neurodegenerative diseases

The role of phosphorylated alpha-synuclein (p-syn)
Research over the past three decades has demonstrated that the major protein in Lewy bodies is an abnormally phosphorylated form of alpha-synuclein.

Alpha-synuclein’s normal function is unknown, but it exists near the terminus of every nerve in the human body and is believed to have a key role in neurotransmitter release and function.

In some cases, for unknown reasons, alpha-synuclein is phosphorylated, which causes the protein to fold incorrectly and results in deleterious effects on nerve cell function.

Abnormal p-syn is now accepted as the earliest step in the development of four (4) different synucleinopathies: Parkinson’s disease, dementia with Lewy bodies, multiple system atrophy, and pure autonomic failure.

Core science leads to a practical clinical tool
The search for a reliable way to demonstrate p-syn deposition has led to failed attempts at serologic tests. Outside of autopsy brain tissue, p-syn has been reliably demonstrated in colonic biopsies and submandibular glands, but these areas are difficult to biopsy and are thus not suitable for widespread diagnostic testing.

At CND Life Sciences, we have capitalized on the knowledge that p-syn exists in peripheral tissue by focusing on cutaneous nerves. Within a small piece of skin, we can visualize nerves that regulate blood vessels, sweat glands, pilomotor function, and sensory perception. These nerves have been demonstrated to contain p-syn in affected patients with >95% sensitivity and >99% specificity.

With our Syn-One Test™, CND is providing neurologists with critical and reliable information to support the diagnosis of synucleinopathy and set a foundation for optimal patient care.

Resources

CASE STUDIES

Check out our selection of short patient case videos (5-10 minutes) and other educational materials.

WHITE PAPERS

Check out our White Papers covering different topics related to neurodegenerative diseases, cutaneous testing, and other areas. We’ve also provided a summary of relevant scientific publications for your convenience.

Synucleinpathies: Parkinson’s Disease

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Synucleinopathies: Dementia with Lewy Bodies

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SCIENTIFIC PUBLICATIONS

Syn-One TestTM: Relevant Scientific Publications

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HANDOUTS

Check out different promotional materials about the Syn-One Test and a Patient Education handout you can provide to your patients if helpful. We also provide you with access to example forms you will need when you incorporate the Syn-One Test in your practice.

Introduction to the Syn-One Test

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The Syn-One Test and Parkinson’s Disease 

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The Syn-One Test and Dementia with Lewy Bodies

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The Syn-One Test and Multiple System Atrophy 

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The Syn-One Test and Autonomic Failure 

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Patient Education 

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FORMS

Syn-One Test Requisition Form

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Syn-One Test Prior Authorization Form

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Syn-One Test Order Form

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CND Post-Biopsy Instructions

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Conducting quality punch skin biopsies in your office is a key part of the Syn-One Test process. CND is here to support you with education and training to help you get started and to assist you and your practice on an ongoing basis. Please contact us at any time to set up a web-based video call or in-person session to learn more and receive the support you need.

Watch our 8-minute narrated video the provides a walk-through of the Syn-One Test skin biopsy procedure and protocol.

Reimbursement

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 help your patients determine their specific benefits coverage before you conduct the required skin biopsies for the Syn-One Test.  CND also offers self-pay options for your uninsured and underinsured patients as needed. 

Clinician Frequently Asked Questions

When should I use the Syn-One Test to help make a more definitive diagnosis?

The Syn-One Test™ provides objective pathological evidence to aid in the diagnostic evaluation of patients with clinical features suggestive of a synucleinopathy. The synucleinopathies include Parkinson’s disease, dementia with Lewy bodies, multiple system atrophy, and pure autonomic failure. An abnormal test that identifies phosphorylated synuclein within cutaneous nerves is highly specific for a diagnosis of a synucleinopathy but cannot distinguish between the synucleinopathies. The result taken with the clinical history and physical exam should help the clinician make a more specific diagnosis.

What is the sensitivity and specificity of the Syn-One Test?

The sensitivity of the Syn-One Test is >95% across all patients with synucleinopathy. The specificity ranges from 95-99% amongst the different synucleinopathy subtypes (i.e. Parkinson’s disease, multiple system atrophy, dementia with Lewy bodies and pure autonomic failure). Specificity is >99% for the Syn-One Test.

Can the Syn-One Test differentiate among the synucleinopathies, including identifying PD vs. MSA?

No, the Syn-One Test will report the presence, or absence of phosphorylated alpha-synuclein which is seen in Parkinson’s disease, multiple system atrophy, dementia with Lewy bodies and pure autonomic failure. The clinical history and examination findings, in combination with the Syn-One Test may support the diagnosis of a particular subtype of synucleinopathy.

Can the Syn-One Test indicate the stage or severity of disease?

No, the Syn-One Test is designed as a diagnostic test. The results will indicate the presence, or absence of a disease known as a synucleinopathy. The results do not indicate the severity of synucleinopathy at this point in time.

Is the Syn-One Test a replacement for the DaTscan?

The Syn-One Test has a higher reported sensitivity and specificity compared to that reported by DaTScan for synucleinopathy. However, there have been no head-to-head comparisons studies published at this time. DaTScan will be abnormal in patients with non-synucleinopathy neurodegenerative diseases such as progressive supranuclear palsy. Thus, the Syn-One Test and the DaTScan are different types of tests, and it their utility will ultimately depend on what question the underlying physician may have.

Is the Syn-One Test covered by 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 help your patients determine their specific benefits coverage before you conduct the required skin biopsies for the Syn-One Test.  CND also offers self-pay options for your uninsured and underinsured patients as needed. 

Will the patient be billed any amount for the Syn-One Test?

As is typical for anatomical pathology tests, the patient is likely to have responsibility for at least a portion of the Syn-One Test bill. For Medicare, patients should expect 80% of the total fee to be covered as part of the plan benefit. If the patient also has secondary or supplement insurance, that plan would also cover all or some of the balance. CND will then send a bill to the patient for any final remaining amount. If the patient is not covered by a health insurance plan or wishes to select a self-pay option, CND can work with them directly. 

What codes will my practice use for conducting the biopsy procedure and what reimbursement might I expect?

The billing code for the first biopsy on a patient is 11103. Each additional biopsy on the day is 11104. So, if a patient has 3 biopsies on one day you would bill 1-11103, and 2-11104.

How do I order the biopsy kits to get started?

To order kits, fill out the Syn-One Test Biopsy Kit Order Form on our website. Once submitted, a CND representative will reach out to you to confirm your order. For first-time orders, CND will include additional information about the biopsy procedure. More information about ordering kits and the biopsy procedure can be found on our website.

Do I need to collect biopsy specimens from all three sites?

We recommend doing three biopsy sites. The reported sensitivity of >95% is based on obtaining the three sites (distal calf, distal thigh, paracervical area). If you perform just one site, the sensitivity decreases to 70%.

Will the patient need any special preparation or follow-up for the biopsy?

There is no preparation necessary before the biopsy. After the biopsy we recommend keeping the area clean and dry for 24 hours. The bandages that are provided in the kits are sufficient to provide the patient with supplies.

How much time should my practice allot for the biopsy procedure?

In most cases the biopsy procedure can be completed in 15 mins for all three sites. It may help the first couple of times to allot 20-30 minutes to be safe, but after a few biopsy procedures, most clinicians can complete all three sites in 15 mins

How long does it take to receive the results from the Syn-One Test?

Syn-One Test results are issued within three weeks of the specimen arriving at CND Life Sciences. CND representatives are available Monday through Friday to answer your questions regarding the progress of your patient’s submitted specimen.

What does the Syn-One Test pathology Report include?

The Syn-One Test Pathology Report includes a comprehensive, detailed examination of the patient’s pathologic results.
The report includes:

  • The patient’s and provider’s information
  • A summary of diagnostic conclusions
  • A macroscopic review of the specimen and the stains performed
  • A microscopic review of the specimen results
  • A review of the patient’s unique pathology with patient-specific photographs and individual biopsy results

For additional information, view the example report and video review on the CND website. CND representatives are available to discuss and answer any questions regarding the Syn-One Test Pathology Report.

What is the Syn-One Test science based upon and are there any key publications?

The Syn-One Test is based on more than 10 years of research by the founders and by several of the leading institutions around the world. The Syn-One Test has been developed based on a number of key publications that are available in the Our Science section of our website (link here):

To have small fiber neuropathy and amyloidosis testing included, do I need to make a specific request?

The Syn-One Test’s primary purpose is on the detection and visualization of phosphorylated alpha-synuclein. We also have to stain the nerves, so a PGP stain is performed in every case and we automatically report the intra-epidermal nerve fiber density. We also perform a Congo Red and H and E stain on every specimen which allows us to look for amyloidosis as well. These are all included in every Syn-One Test.

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