Amprion Announces Granting of European Patents for Seed Amplification Assay Platform

SAN DIEGO, August 15, 2023Amprion, a global leader in neurodegenerative disease diagnostics, continues to fortify its Intellectual Property surrounding the company’s proprietary methodology for highly sensitive detection of misfolded proteins and amyloid-like aggregates. Recently, fundamental patents have been issued in the EU and UK which expands Amprion’s extensive coverage in key geographies. The issued patents apply broadly to the methodology known alternatively as Seed Amplification Assay (SAA), Protein Misfolding Cyclic Amplification (PMCA) and Real-Time Quaking-Induced Conversion (RT-QuiC).  

“The granting of these patents recognizes Amprion’s crucial role, along with our partners at the Universities of Texas and Edinburg, in development of Seed Amplification Assays for diagnosis of neurodegenerative diseases,” said Russell Lebovitz, M.D., Ph.D., CEO and co-founder of Amprion. “We are highly committed to making this methodology accessible globally to research laboratories and biopharmaceutical partners. Access to highly sensitive and specific diagnostics such as SYNTap allow those who are tirelessly working to develop precision medicines to be more effective and efficient at targeting the underlying pathologies.”

Amprion’s SAA patent portfolio is divided into four main families based on the misfolded protein to be detected: alpha-synuclein, amyloid beta, tau, and prion protein (PrP). Amprion is the only entity, commercial or otherwise, that has issued patents in each of the major misfolded protein categories.

Amprion’s extensive, owned or exclusively licensed, alpha-synuclein portfolio currently includes multiple allowed and/or issued patents. Patent locations include the United States, EU, Japan, UK, Korea, Singapore, Australia, Israel, Canada, and Mexico, with applications pending in India, China, Hong Kong, and Brazil. Amprion also has an issued US patent and pending applications worldwide directed to its proprietary alpha-synuclein SAA substrate plus other key components needed for robust, reliable and reproducible application of the technology.

To ensure uniform and consistent results across different research laboratories, Amprion has an active collaborators program and is formalizing a research licensing program.  

Amprion is also expanding international access to clinical testing with its SAA for alpha-synuclein, offered under the brand name of SYNTap® in North America, by licensing its methodology to selected partner laboratories who reside/operate within distinct geographic regions. During this period of licensing and validation, the SYNTap® test is available through Amprion’s CLIA-certified and CAP-accredited lab in San Diego. 

Amprion plans to lead and perform all clinical trial collaborations to ensure the highest degree of quality and consistent performance needed by Biopharma partners.

About SYNTap®:
Amprion’s SYNTap Biomarker Test is a first-in-class-qualitative Laboratory Developed Test (LDT) and the only seed amplification assay available to aid the diagnosis of synucleinopathies such as Parkinson’s Disease (PD), Lewy Body Dementia (LBD/DLB), and Alzheimer’s Disease (AD) with Lewy Body variant. The U.S. Food and Drug Administration (FDA) granted Amprion a Breakthrough Device Designation in 2019 for use of the test as an aid in the diagnosis of PD. SYNTap became commercially available in 2021.

About Amprion:
Amprion is a global leader in the advancement of neurodegenerative disorder diagnosis through seed amplification testing. As the global population ages, Amprion aims to accelerate precision medicine for neurodegenerative disorders by helping biopharma partners identify new drug candidates and underlying pathologies. The amplification testing methodology was originally developed by Claudio Soto, PhD, Amprion’s Co- Founder and has been further enhanced and validated by Amprion’s in-house scientific team. Amprion currently holds multiple U.S. and International patents for SAA methodology and strives to launch more biomarker tests to detect a wide range of early-stage neurodegenerative disorders.

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.