SYNTap Biomarker Test helps doctors distinguish Parkinson’s from Parkinsonism in early stages

PD-New Inights

For the first time in history, Amprion’s breakthrough SYNTapÒ Biomarker Test can help doctors effectively distinguish Parkinson’s Disease (PD) from Parkinsonism early. This innovative test accurately detects the presence or absence of misfolded Synuclein, a crucial biomarker of these diseases, in spinal fluid.

PD affects 10 million people globally. About one million Americans live with PD, and 60,000 new cases are added each year. Unfortunately, despite billions of spending in drug R&D over the past three decades, there is no cure for Parkinson’s–yet.

Clinical diagnosis of PD is challenging, particularly at early stages when treatments are likely to be more effective. Studies have found patients are given the wrong diagnosis more than 20% of the time. The primary culprit is PD’s overlapping symptoms with other movement disorders. When doctors can rule out PD, those showing similar movement disorders are referred to as having Parkinsonism.

PD is characterized by neuronal death in the substantia nigra region of the midbrain, causing the loss of dopamine innervation in the basal ganglia. At autopsy, PD patients’ brains show misfolded synuclein aggregates in the form of Lewy Bodies, particularly in the substantia nigra.

Research studies find that nearly 100% of PD patients have Lewy Bodies at autopsy, making misfolded synuclein a hallmark of the disease.

“Although PD and Parkinsonism share similar movement symptoms, on the molecular level, Parkinsonism rarely shows evidence of misfolded synuclein associated with Lewy Bodies,” commented Amprion CEO Russ Lebovitz M.D., Ph.D.

So how do doctors currently differentiate PD from Parkinsonism? Historically, the investigative diagnostic journey can take several years. For example, the famous singer Linda Ronstadt was diagnosed with PD for more than six years. But her diagnosis was later revised as Progressive Supranuclear Palsy, a form of Parkinsonism.

“Many doctors give their patients a dose of dopamine-enhancing drugs and look for rapid, short-term improvement in symptoms. However, for Parkinsonism patients, the use of dopamine-enhancing drugs may bring serious adverse reactions,” added Dr. Lebovitz.

As a result, clinicians are often confounded by the shared symptoms of Parkinson’s and Parkinsonism at early stages. “There is an urgent need for a validated clinical test as it can significantly improve the confidence of diagnosis and help to optimize treatment in many cases,” said Joseph Quinn, M.D., professor of neurology in the School of Medicine at Oregon Health & Science University.

For the first time in history, Amprion’s breakthrough SYNTap Biomarker Test can help doctors effectively distinguish PD from Parkinsonism in early stages. This innovative test accurately detects the presence or absence of misfolded synuclein in spinal fluid.

“We are excited about the promise of molecular testing. Knowing the biomarker gives us a target for effective treatment and drug innovation. By directing proper medicine to the target biomarker, we can develop successful treatments for Parkinson’s,” concluded Dr. Lebovitz.

Amprion is securing FDA approval for the SYNTap Test and anticipates rolling out other biomarker tests to help physicians diagnose other neurodegenerative conditions.

ABOUT AMPRION

A leader in Prion Detection Science™, Amprion innovates biomarker testing for brain diseases. Our SYNTapÒ Biomarker Test helps doctors diagnose Parkinson’s, Lewy Body Dementia, and Alzheimer’s with Lewy Bodies. Awarded FDA Breakthrough Device Designation for its detection technology, Amprion strives to accelerate personalized medicine for neurodegenerative diseases through molecular testing.

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.