Accurate PD Diagnosis

There is a need to enhance the clinicians’ ability to diagnose Parkinson’s Disease and Atypical PD, especially in early stages.

A man performing Alzheimer's disease research

SYNTap Test Capabilities

This biomarker test can detect α-Synuclein with 87% sensitivity, 97% specificity, and 93.9% accuracy.

Specification Sheet

SYNTap Spec Sheet - Disease Lead

Most physicians are comfortable making the clinical diagnosis of PD; however, there is still a significant amount of patients who are not easily differentiated from other movement disorders.

“The accuracy of Parkinson’s Disease clinical diagnosis has not significantly improved in the last 25 years. This is particularly noted in the early stages of disease, where response to dopaminergic treatment is less defined and hallmarks of alternative diagnoses such as atypical parkinsonism may not have emerged.”(Ref.1)

SYNTap Test Aids in PD Clinical Diagnosis

There is a biomarker test that can help confirm PD or Atypical PD. SYNTap provides highly sensitive and specific detection of α-Synuclein aggregates and has received FDA Breakthrough product designation for use to support diagnosis of Parkinson’s Disease.

“Accuracy of clinical diagnosis performed by movement disorders experts is 79.6% of initial assessment to 83.9% of refined diagnosis after follow-up. “ (Ref.1)

“The neuropathological hallmark of PD is the abnormal accumulation and aggregation of alpha synuclein protein (α-Syn) in form of Lewy bodies and Lewy neurites.” (Ref.2)

SYNTap Test Capabilities

  • Amprion recently performed an Analytical/clinical accuracy study using biobank samples provided by the Michael J. Fox Foundation (MJFF) Parkinson’s Progression Markers Initiative (PPMI) repository.
  • A total of 164 samples were included in the analysis: 55 PD, and 109 with no diagnosed neurological disease.
  • All samples were analyzed blinded, and accuracy assessed by comparing test results to sample PPMI clinical cohort assignments.
  • SYNTap Test shows an overall 93.9% accuracy with:
    • 87.3% sensitivity
    • 97.2% specificity

Download the SYNTap Test Specification Sheet for details.

ATTENTION!!

Amprion has some important news we need to share with you!

To improve patient access to the SYNTap® biomarker test (CSF), Amprion is reducing the self-pay price for tests with service dates on or after July 1, 2023.

Old self-pay price: $1500.00. New self-pay price: $995.00

Effective July 1, 2023, there is a New ABN (Advanced Beneficiary Notification) form for use when ordering the SYNTap® biomarker test (CSF) for patients on Medicare. Order Process

CPT/PLA – The SYNTap® test has been issued a dedicated PLA code to be used when billing: 0393U
 
We have applied to be a medicare provider and will soon be able to courtesy bill Medicare for your patients.