Accurate PD Diagnosis

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

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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.

Please Note: Important Billing Info

To improve patient access to the SYNTap® Biomarker CSF Test, Amprion offers the following billing options:

  • List price of $1500, with courtesy billing for both Medicare and private insurance.
  • An affordable self-pay price of $995 (patients may qualify for financial assistance and/or interest-free payment options).
  • Prices are effective as of January 1, 2024, and are subject to change.

Please note: Amprion is a Medicare participating provider, however, the SYNTap test does not currently have Medicare coverage determination. Also, Amprion is not yet in network with most insurers.

The SYNTap Biomarker CSF Test has been issued a dedicated CPT® PLA code to be used when billing: 0393U.

For additional information, please visit our billing page.