If you’re considering implementing the Syn-One Test® in your practice, you probably have several questions about how it works and when you should use it. Here are answers to some of the most common questions we’ve received from other clinicians.

When should I use the Syn-One Test?
The Syn-One Test provides objective evidence of phosphorylated alpha-synuclein in cutaneous nerves with high sensitivity and specificity. 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 definitive diagnosis and treatment plan.

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 (ie, Parkinson’s disease, multiple system atrophy, dementia with Lewy bodies, pure autonomic failure, and REM sleep behavior disorder) with 95.5% sensitivity and 96.7% specificity. These data are based on a prospective, multisite, blinded study of 428 patients, supported by funding from the NIH and were recently published in JAMA. Read the study abstract. Learn more about the science supporting the Syn-One Test.

What is the Syn-One Test process?
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 (distal calf, distal thigh, paracervical area), taken during one patient visit. In most cases, the biopsy procedure can be completed in 15 minutes for all three sites.

Samples are sent to our CLIA-certified and CAP-accredited laboratory in Scottsdale, Arizona, where they are processed and analyzed by medical pathologists.

Watch a video about the biopsy procedure.

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 CND recommends the collection of three (3) skin biopsy samples from three (3) distinct anatomical locations. The analysis of multiple biopsy sites to support optimal performance of the Syn-One Test 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.

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’s arrival at CND Life Sciences. CND representatives are available Monday through Friday to answer your questions regarding the progress of your patient’s submitted specimen. See a sample pathology report.

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, supported by our strong 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.

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 cost. 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.

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 comparison studies published. 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 the utility of each will ultimately depend on what question the clinician may have.

Is the Syn-One Test FDA approved?
The Syn-One Test is classified as a laboratory developed test (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 US through the Clinical Laboratory Improvement Amendments (CLIA).

How do I order biopsy kits to get started?
To order kits, fill out the Skin Biopsy Test Kit Order Form. 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.

References:

Gibbons CH, Levine T, Adler C, et al. Skin biopsy detection of phosphorylated ⍺-synuclein in patients with synucleinopathies. JAMA. Published online March 20, 2024. doi:10.1001/jama.2024.0792