FDA Breakthrough Device Designation

One small step for science, one giant leap for Parkinson’s!

This meaningful award soon brings to reality a long-held dream: the ability to diagnose Parkinson’s early and accurately. How early? Our molecular-based technology allows doctors to diagnose Parkinson’s patients decades before any symptoms.

Yes, we can detect Parkinson’s disease decades before the patient shows any early signs of Parkinson’s.

How amazing is this? Soon, Amprion will offer this test commercially once the company obtains all the regulatory approvals.

To treat the disease, one must find out the disease exists in the body. The earlier, the better.

This empowers people with early prevention to delay or even stop the progression. Although Parkinson’s has no cure yet, Amprion’s goal is to find a cure through biomarker drug development and testing through targeted clinical trials. Biomarker testing equips us with biometrics data. And molecular data has been the missing link in drug development to develop treatments for Parkinson’s disease.

This award from the US Food and Drug Administration comes on the heels of Amprion’s decades’ long research pioneering the detection of misfolded proteins, including Abeta and Tau. These two prions are known as biomarkers driving Alzheimer’s and other neurodegenerative disorders. Amprion aims to accelerate testing development and review and approval from the FDA to prepare for a commercial rollout.

Designed to speed up the development and review of medical devices, the Food and Drug Administration’s Breakthrough Devices Program strives to accelerate effective treatments and diagnosis of life-threatening, irreversible diseases. This new FDA breakthrough status will enable Amprion to accelerate the development and review of its diagnostic test for Parkinson’s to obtain final approval for product launches within the next 18 months.

We’re thrilled to share this scientific breakthrough as we race to cure Parkinson’s!

Read Full Press Release Here

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.