This breakthrough biomarker test aids physicians in diagnosing Parkinson’s, Lewy Body Dementia, and Alzheimer’s with Lewy Body variant.
The SYNTap Test is a qualitative test. It can be used to rule in or rule out synuclein pathology. The test amplifies misfolded α-synuclein aggregates and can detect even minute levels in cerebrospinal fluid (CSF).
Detection of misfolded α-synuclein in CSF is consistent with the presence of active synucleinopathies such as Parkinson’s Disease (PD) or Lewy Body Dementia (LBD). Synucleinopathies can also be present as an underlying pathology that complicates the effective management of other diseases, including Alzheimer’s.
The SYNTap Test is performed exclusively at our CLIA and CAP-accredited laboratory in San Diego.
The SYNTap Test is a clinical biomarker test and must be ordered by a physician. Along with other clinical and diagnostic findings, doctors can use our test results to help guide patient care and management.
Amprion’s test benefits patients exhibiting signs and symptoms of a potential synucleinopathy such as:
In blinded research studies, the SYNTap Test has been shown to:
We are in the process of submitting these results to peer-review journals and will post them upon acceptance.
SYNTap Test detects misfolded synuclein in CSF. Misfolded synuclein can cause both LBD cognitive disorders and Parkinson’s movement disorders.
Patients with movement disorders only who test positive are likely diagnosed by their physician with Parkinson’s Disease.
Patients with cognitive symptoms (memory loss or hallucinations) who test positive are likely diagnosed by their physician with LBD.
The test is currently available in the US, except Maryland, New York, and Rhode Island. We are working hard to complete the rollout in these states as soon as possible.
The US FDA awarded Amprion SYNTap Test a Breakthrough Device Designation for detecting misfolded α-synuclein aggregates in patients undergoing evaluation for Parkinson’s Disease (PD). Amprion is in the process of seeking FDA approval for the SYNTap Biomarker Test.
This FDA designation is given to medical devices with the following qualifications:
The SYNTap Biomarker Test is performed using Amprion’s proprietary Prion Detection Science℠, called Seed Amplification Assay (SAA). It mimics the biological process by which proteins misfold and aggregate.
The accuracy of the SYNTap Test was evaluated against CSF samples from patients with a clinical diagnosis of PD or LBD and control patients with no known neurological disease.
Research studies show misdiagnosis of PD and LBD occurs over 20% of the time. The SYNTap Test has proven to confirm patients with synucleinopathy and rule out those who do not currently have the underlying pathology. Thus, the SYNTap Biomarker Test provides physicians a valuable tool empowering accurate diagnosis.
J Neurol Neurosurg Psychiatry. 2018 Apr;89(4):358-366. doi: 10.1136/jnnp-2017-316844. Epub 2017 Oct 13. Accuracy of clinical diagnosis of dementia with Lewy bodies: a systematic review and meta-analysis
Neurology. 2016 Feb 9;86(6):566-76. doi: 10.1212/WNL.0000000000002350. Epub 2016 Jan 13. Accuracy of clinical diagnosis of Parkinson disease: A systematic review and meta-analysis
Amprion will provide the SYNTap Test lab result report to the prescribing healthcare provider within 15 business days of receiving samples.
Healthcare providers can select the preferred report shipment method on the test order form. Options include:
A “Not Detected” SYNTap Test result does not mean that a patient will not develop a synucleinopathy in the future.
A patient’s disease may change or evolve; if you continue to suspect a synucleinopathy in the patient, you can re-order a test. We suggest waiting for at least 12-months.
First off, many brain diseases share similar symptoms with Parkinson’s or Lewy Body Dementia. A negative SYNTap Test rules out misfolded Synuclein as the cause, eliminating the likelihood of PD or LBD. As a result, physicians can focus on identifying other causes and prescribing proper treatments to effectively manage these symptoms.
Amprion has determined the SYNTap Test detection limit to be ~44 femtograms/mL, using alpha-synuclein aggregates as a proxy.
No interference was seen when conjugated bilirubin, hemoglobin, albumin, and whole blood were spiked into CSF at levels much higher than would be expected in normal practice.
The interference of specific medications has not been formally evaluated. However, no evidence of interference has been seen in research studies using CSF samples collected from healthy donors or patients taking various prescription and over-the-counter medications.
You can order test kits here.
Fill out the downloadable Test Requisition and ABN Form.
Email us with any questions at Customer.Service@AmprionDx.com
Your office (or affiliated institution) will collect blood-free CSF according to standard institutional practices.
Amprion requires a 1mL CSF sample with an acceptable minimum volume of 0.5 mL.
The submitted sample can be from any fraction (e.g., beginning, middle, or end of the draw) or tube of a blood-free CSF draw.
You may use your sample tube or ones provided by Amprion. Screw-top plastic cryovials or protein LoBind tubes are preferred. Sample tubes with a snap-cap may be used but should be wrapped securely to prevent leakage during shipping.
Samples can be frozen to -20°C or -80°C and shipped on dry ice or may be held refrigerated and shipped with an ice pack.
Refrigerated samples should be shipped within 24 hours of collection.
Samples should be shipped via FedEx overnight express to arrive at Amprion’s laboratory during normal business hours Monday-Friday between 9 AM-5 PM PST.
***Please note: we do not accept samples arriving on Saturdays or Sundays.***
10355 Science Center Drive, Suite 240,
San Diego, CA 92121
Telephone: 1‑858-461-6338 (M-F 9AM – 5 PM PST)
Amprion will provide you with a lab report within 15 business days of receiving a CSF sample.
Please indicate on the Test Requisition Form your preferred method of receiving the lab test result:
Currently, Amprion offers this test on a self-pay basis. However, we are working diligently to establish reimbursement from private insurance providers, Medicare, or Medicaid.
Your patient will receive a bill in the mail after Amprion sends you the lab report. We accept credit cards, personal checks, and money orders.
Patients can make a payment via regular mail, by credit card using our automated system at 1-800-877-9236 or by calling the office number below, or online at PayPBO.com.
Patient Billing Office:
Telephone: 1-800-878-7561 (M-F 7AM – 5PM MST)
Please contact our Patient Billing Office for details about payment options and/or eligible financial assistance programs.
For Medicare patients, an Advance Beneficiary Notice (ABN) is required. Please include the patient-signed ABN Form, with the requisition and CSF sample shipment to Amprion’s lab.