SAAmplify™-ɑSYN Test FAQ

What’s the SAAmplify-ɑSYN Test?

The SAAmplify-ɑSYN 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 (DLB).  Synucleinopathies can also be present as an underlying pathology that complicates the effective management of other diseases, including Alzheimer’s.

Who performs the SAAmplify-ɑSYN Test?

The SAAmplify-ɑSYN Test is performed exclusively at our CLIA and CAP-accredited laboratory in San Diego.

Who should take the SAAmplify-ɑSYN Test?

The SAAmplify-ɑSYN 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:

• Parkinson’s disease (PD or atypical Parkinson’s)
• Lewy body dementia (or dementia with Lewy bodies, DLB)
• Alzheimer’s disease (AD)
• Mild cognitive impairment (MCI)
• Multiple system atrophy (MSA)

In blinded research studies, the SAAmplify-ɑSYN Test has been shown to:

• Detect aggregates of misfolded α-synuclein years before symptoms of synucleinopathy appear.
• Detect aggregates in patients diagnosed with other neurodegenerative diseases, such as Alzheimer’s Disease, who may not show signs of Lewy body disease.

Amprion is in the process of submitting these results to peer-reviewed journals and will post them upon acceptance.

Does SAAmplify-ɑSYN Test work differently for patients with PD or LBD?

The SAAmplify-ɑSYN Test detects misfolded synuclein in CSF. Misfolded synuclein can cause both DLB cognitive disorders and Parkinson’s movement disorders.

Patients with movement disorders only who test positive would likely be evaluated by their physician for Parkinson’s disease.

Patients with cognitive symptoms (memory loss or hallucinations) who test positive would likely be evaluated by their physician for DLB or AD/DLB.

Where is SAAmplify-αSYN Test available?

The test is currently available in the U.S., except in New York. We are working hard to complete the rollout in this state at soon as possible.

FDA Breakthrough Device Designation

The U.S. FDA awarded Amprion SYNTap Test (now SAAmplify-ɑSYN Test) a Breakthrough Device Designation for detecting misfolded α-synuclein aggregates in patients undergoing evaluation for Parkinson’s disease (PD).

This FDA designation is given to medical devices with the following qualifications:

• Provide effective diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.
• Offer a service when no approved or cleared alternatives to exist.
• Represent significant advantages over approved alternatives, and/or its availability is in the best interest of the patients.

How the SAAmplify-ɑSYN Test works

The SAAmplify-ɑSYN Test is performed using Amprion’s proprietary seed amplification assay (SAA). It mimics the biological process by which proteins misfold and aggregate.

• If aggregates are formed in the reaction, they are detected using an amyloid-specific fluorescence binding probe.
• If the sample has no endogenous aggregates, amplification does not occur, and fluorescence remains below the detection cutoff.

The accuracy of the SAAmplify-ɑSYN Test was evaluated against CSF samples from patients with a clinical diagnosis of PD or DLB and control patients with no known neurological disease.

Research studies show misdiagnosis of PD and DLB occurs over 20% of the time. The SAAmplify-ɑSYN Test has proven to confirm patients with synucleinopathy and rule out those who do not currently have the underlying pathology. Thus, the SAAmplify-ɑSYN Test provides physicians a valuable tool empowering accurate diagnosis.

References:

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

Result report

Amprion will provide the SAAmplify-ɑSYN 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:

• Secure FAX
• Encrypted email, or
• US mail

Click to see the sample report for DETECTED or NOT-DETECTED.

Does a “Not Detected” test result mean my patient will not develop a synucleinopathy in the future?

A “Not Detected” SAAmplify-ɑSYN 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.

What if the SAAmplify-ɑSYN Test is negative, and yet my patient shows symptoms?

First off, many brain diseases share similar symptoms with Parkinson’s or Lewy body dementia. A negative SAAmplify-ɑSYN Test rules out misfolded synuclein as the cause, eliminating the likelihood of PD or DLB. As a result, physicians can focus on identifying other causes and prescribing proper treatments to effectively manage these symptoms.

What is the detection limit?

Amprion has determined the SAAmplify-ɑSYN Test detection limit to be ~44 femtograms/mL, using alpha-synuclein aggregates as a proxy.

Do any substances interfere with the SAAmplify-ɑSYN Test?

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.

Order the SAAmplify-ɑSYN Test Kits

You can order test kits here.

Complete the Test Requisition Form

Fill out the downloadable Test Requisition and ABN Form.

Contact Us

Email us with any questions at ClientServices@AmprionDx.com

Sample Requirements 

Your office (or affiliated institution) will collect blood-free CSF according to standard institutional practices.

Sample volume

Amprion requires a 1 mL 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.

Sample tube

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.

Sample storage

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.

Sample shipment 

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.***

Amprion Laboratory
10355 Science Center Drive, Suite 240
San Diego, CA 92121

Telephone: 1‑858-461-6338 (M-F 9AM – 5 PM PST)
Email: ClientServices@AmprionDx.com

How will I receive the lab results?

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:

• Secure FAX
• Encrypted email, or
• US mail

Billing and Reporting

Does insurance cover the SAAmplify-ɑSYNvTest?

Amprion is not yet in network with private insurers, but we do offer courtesy billing on behalf of patients. We also offers the test on a self-pay basis. We are working diligently to establish reimbursement from private insurance providers, Medicare, and Medicaid.

How do patients pay for the test?

Patient Billing Office:
Telephone: 1-800-878-7561 (M-F 7 AM – 5 PM MST)
Email: questions@physiciansbillingoffice.com

What if my patient cannot afford the test?

Please contact our Patient Billing Office for details about payment options and/or eligible financial assistance programs.

Is ABN required for Medicare patients? 

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.