Amprion, a global leader in neurodegenerative disorder diagnostics, has announced the successful initial close of $6 million in its $15 million Series B financing round. The round was led by Formation Venture Engineering (FVE), with participation from Eli Lilly and Company and Amprion’s Series A investors. This funding will enhance Amprion’s commercial reach and support increased R&D efforts to further its mission of revolutionizing brain disease diagnosis.
Amprion Advances Neurodegenerative Disorder Diagnostics with Seed Amplification Testing
Amprion has developed innovative seed amplification testing to detect small amounts of misfolded proteins in biological samples, such as cerebrospinal fluid (CSF). Its SAAmplify-αSYN biomarker test (formerly SYNTap®) is the only validated seed amplification assay designed to aid in diagnosing synucleinopathies linked to Parkinson’s disease, Lewy body dementia, and Alzheimer’s disease with neocortical Lewy body co-pathology. The company has also partnered with several pharmaceutical firms to develop therapies for Parkinson’s and other neurodegenerative conditions. Recently, the U.S. Food and Drug Administration (FDA) issued a Letter of Support recommending the use of the alpha-synuclein (α-syn) seed amplification assay (synSAA) for research and clinical trials.
“We are proud to support Amprion in its mission to revolutionize brain disease diagnosis and accelerate precision medicine for neurodegenerative disorders,” said Rahul Bhansali, Managing Partner at FVE. “Transitioning to biologically-based diagnoses rather than symptom-based ones will be transformative for both patients and clinicians, and we are excited to back Amprion as they advance this novel technology.”
Recent studies published in leading journals like The Lancet Neurology and Alzheimer’s and Dementia have validated the technology, confirming the high sensitivity and specificity of Amprion’s SAA for detecting α-synuclein aggregates in CSF, with results corroborated by autopsy findings.
“We are honored to have FVE and Eli Lilly’s support as we advance precision medicine for neurodegenerative disorders,” said Russell Lebovitz, MD, PhD, CEO and co-founder of Amprion. “The strong interest from leading neurology centers and pharmaceutical companies reflects confidence in our technology and our vision to provide clarity to patients and their families through our biomarker test.”
Amprion has also submitted an application to New York’s Department of Health to expand its clinical footprint in the U.S. Additionally, the company plans to restructure its Board to include up to three new members with industry expertise to enhance regulatory pathways and facilitate growth.
About SAAmplify-αSYN (formerly SYNTap®)
Amprion’s SAAmplify-αSYN biomarker test is a first-in-class qualitative Laboratory Developed Test (LDT) and the only seed amplification assay available to assist in diagnosing synucleinopathies such as Parkinson’s disease (PD), Lewy body dementia (LBD/DLB), and Alzheimer’s disease (AD) with neocortical Lewy body co-pathology. The FDA granted Amprion Breakthrough Device Designation in 2019 for the test’s use in diagnosing PD, and it became commercially available in 2021.
About Amprion
Amprion is a leader in advancing neurodegenerative disorder diagnostics through seed amplification testing. The company’s intellectual property around SAA methodology extends to research, drug development, and commercialization. The SAAmplify-αSYN biomarker test is crucial for diagnosing synucleinopathies related to Parkinson’s, Lewy body dementia, and Alzheimer’s disease, while also accelerating precision medicine by helping biopharma partners identify new drug candidates and underlying pathologies.