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.
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 five (5) different synucleinopathies: Parkinson’s disease, dementia with Lewy bodies, multiple system atrophy, pure autonomic failure, and REM sleep behavior disorder.*
*REM sleep behavior disorder (RBD) is considered a prodromal synucleinopathy. Sensitivity and specificity data on the Syn-One Test for RBD has not been established. Ongoing research is being conducted in patients with RBD.
Core science solves an unmet need
Historically, the search for a practical, reliable way to detect abnormal, phosphorylated alpha-synuclein (p-syn) deposition in a patient’s nervous system to help diagnose serious neurological disorders like Parkinson’s disease has been challenging:
- Biopsies of the colon and submandibular glands are invasive and difficult to perform
- Blood, saliva, and other tissue forms have proved to be difficult vehicles for effective detection
- DaTscans and PET scans are costly, not widely available, and lack high sensitivity and specificity
CND Life Sciences has capitalized on the knowledge that p-syn exists in cutaneous nerve tissue and can be identified early in the disease process.
Within a small piece of skin, we can visualize nerves that regulate blood vessels, sweat glands, pilomotor function, and sensory perception. In the landmark Synuclein-One Study, sponsored by the National Institutes of Health (NIH), the core methods of the Syn-One Test detected phosphorylated alpha-synuclein in patients with a clinically confirmed synucleinopathy with nearly 96% sensitivity and 97% specificity. The results from the Synuclein-One Study are very similar to those presented by Gibbons et al at the 2020 AAN meeting, also demonstrating over 95% sensitivity and specificity for phosphorylated alpha-synuclein.
Furthermore, in the April 2021 edition of Neurology, Donadio et al published results demonstrating 90% sensitivity and 100% specificity for skin-based detection of p-syn using immunofluorescence, the same technique employed by CND Life Sciences for the Syn-One Test.
With our Syn-One Test, CND Life Sciences is providing neurologists with critical and reliable information to support the diagnosis of synucleinopathies and set a foundation for optimal patient care.
*Gibbons CH, Levine T, Adler C, et al. Skin Biopsy Detection of Phosphorylated α-Synuclein in Patients With Synucleinopathies. JAMA. 2024;331(15):1298–1306. doi:10.1001/jama.2024.0792
Gibbons C. Wang N. Rajan S. et al. Cutaneous alpha-synuclein deposition across the synucleinopathies. Neurology. 2020:94(suppl15). 2020 Annual Meeting Abstracts.
Resources
CASE STUDIES
Check out our selection of short patient case videos (5-10 minutes) and other educational materials.
Evaluation of Patients with Mixed Tremor Types
Evaluation of Patients with Autonomic Failure
Evaluation of Patients with Cognitive Dysfunction
The Patient with Suspected Multiple System Atrophy
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.
SCIENTIFIC PUBLICATIONS
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.
FORMS
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 short narrated video the provides a walk-through of the Syn-One Test skin biopsy procedure and protocol.
Reimbursement
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.
The Syn-One Clinician Network™
The Syn-One Clinician Network is a directory of some of the hundreds of neurologists who are using the Syn-One Test® to aid in the diagnosis of Parkinson’s disease and other neurological disorders.
Clinician Frequently Asked Questions
When should I use the Syn-One Test to help make a more definitive diagnosis?
A clinician should use their best judgment when ordering the Syn-One Test to help make a more definitive diagnosis of a synucleinopathy. The Syn-One Test provides objective evidence of phosphorylated alpha-synuclein in cutaneous nerves with high sensitivity and specificity (along with other helpful pathological findings from the skin biopsy analysis). Syn-One pathology results, along with a clinician’s assessment of each patient’s clinical features, are intended to help a clinician establish a more confident diagnosis and treatment plan at any point during the patient’s timeline of symptoms.
What is the sensitivity and specificity of the Syn-One Test?
The Syn-One Test detects phosphorylated alpha-synuclein in patients with a clinically confirmed synucleinopathy with nearly 96% sensitivity and 97% specificity (i.e., Parkinson’s disease, multiple system atrophy, dementia with Lewy bodies, pure autonomic failure). This data is based on results from a prospective, multisite, blinded study of 428 patients, supported by funding from the NIH, and presented at the 2023 American Academy of Neurology (AAN) meeting in Boston and published in the Journal of American Medical Association.
Gibbons CH, Levine T, Adler C, et al. Skin Biopsy Detection of Phosphorylated α-Synuclein in Patients With Synucleinopathies. JAMA. 2024;331(15):1298–1306. doi:10.1001/jama.2024.0792
Can the Syn-One Test differentiate among the synucleinopathies, including identifying PD vs. MSA?
CND’ scientific founders, Dr. Christopher Gibbons and Dr. Roy Freeman, both professors at Harvard Medical School, published data in 2023 demonstrating the potential for Syn-One to help differentiate Parkinson’s disease (PD) from multiple system atrophy (MSA). A link to the abstract in the April 2023 edition of Neurology is provided here. Furthermore, Dr. Gibbons presented data at the 2023 American Academy of Neurology (AAN) meeting in Boston demonstrating how specific patterns of synuclein deposition, along with other markers, might provide more precise “signatures” that help distinguish pathologies across the synculeinopathies. CND is studying the possibility to analyze “Synuclein Signatures” in the skin to help characterize one synucleinopathy from another for future clinical use.
At this time, the Syn-One Test does not provide a pathology report with these possible Synuclein Signatures and differential diagnosis insights. However, a clinician who has ordered a Syn-One Test and would like to speak to a member of CND’s Medical Affairs team about potential signature insights, they can request a consultation call.
Can the Syn-One Test indicate the stage or severity of disease?
Currently, the Syn-One Test is designed to identify and visualize the underlying pathology related to synucleinopathies like Parkinson’s disease, but does not offer a prognosis on disease severity and progression. However, CND continues to examine the patterns and signatures of synuclein pathology and other neurological markers in cutaneous tissue to help determine possible disease course and severity in the future.
Is the Syn-One Test covered by insurance?
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 the required skin biopsies for the Syn-One Test are performed. CND also offers self-pay options and payment plans and participates with Care Credit 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 typically expect 80% of the total fee to be covered as part of the plan benefit. If the patient also has secondary or supplemental insurance, that plan may also cover all or some of the balance. CND will then send a bill to the patient for any final 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.
Please note patients may be billed a facility charge depending on the location; these charges are completely up to the facility and CND would not be able to provide this estimate for patients. Clinicians should make sure patients are aware of this possibility and may check with their affiliated facility for further details.
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 11104. Each additional biopsy on the day is 11105. If a patient has three (3) biopsies on one day you would bill 1-11104, and 2-11105.
How do I order the biopsy kits to get started?
To order kits fill out the Skin Biopsy Test 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?
To ensure maximum sensitivity and support accurate diagnostic assessment using the Syn-One Test and Small-Fiber Dx, CND recommends the collection of three (3) skin biopsy samples from three (3) distinct anatomical locations from the patient (distal calf, distal thigh, paracervical area), taken simultaneously during the patient visit. The analysis of multiple biopsy sites to support optimal performance of the Syn-One Test and Small-Fiber Dx is described in a multitude of scientific publications from several research groups over the last decade. However, the number of biopsy site samples collected from the patient is at the sole discretion of the ordering clinician. CND only bills for the exact number of biopsy sites provided by the ordering clinician according to the allowable billing units for each billing code.
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 provided in the kits are sufficient.
How much time should my practice allot for the biopsy procedure?
In most cases the biopsy procedure can be completed in 15 minutes 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 minutes.
How long does it take to receive the results from the Syn-One Test?
Most Syn-One Test results are returned in 21 days; however, this timeline may vary. If you have questions, please contact your Clinical Account Manager at support@cndlifesciences.com
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 sample report. CND representatives are available to discuss and answer any questions regarding the Syn-One Test Pathology Report. For clinical questions, you may also request a consult with a clinician member of our Medical Affairs team.
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 CND’s founders and by several leading institutions around the world. The Syn-One Test has been developed based on a number of key publications available in the Our Science section of our website.
To have small fiber neuropathy and amyloidosis testing included, do I need to make a specific request?
The recommended stains and analyses for the Syn-One Test, include:
- Special stain for phosphorylated alpha-synuclein
- PGP 9.5 for intraepidermal nerve fiber density
- Congo red for amyloidosis
- H&E (Hematoxylin and Eosin) for skin morphology
Given this recommended set of stains and analyses for the Syn-One Test, special order requests are not necessary. However, if a clinician does not want to include Congo red for amyloidosis considerations, they can request on the order form to exclude this component from the Syn-One Test.
Is the Syn-One Test FDA approved?
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 laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA).
For Clinicians: Request a Skin Biopsy Test Kit
Our suite of neurodiagnostic tests provides clinicians with objective pathological insights on diseases that are often difficult to diagnose. Using our Skin Biopsy Test Kit, collect three small skin biopsies from your patient, send them to our CLIA-certified and CAP-accredited lab, and CND will provide important pathological insights to support a diagnosis.
Order a Kit
