Amprion raises $6M to develop test for Parkinson’s disease
Biomarker test can help identify Parkinson's in early stages
Amprion said it has raised the initial $6 million of a $15 million financing deal that will help develop and commercialize SAAmplify, its diagnostic test for Parkinson’s disease and other neurodegenerative conditions linked to the formation of toxic clumps by the protein alpha-synuclein.
The test, SAAmplify, was launched in the U.S. this year and can help doctors diagnose Parkinson’s, particularly in the early stages of disease when symptoms are not yet obvious. The test builds on the company’s seed amplification assay (SAA) originally called SYNTap, which was launched in the U.S. in 2021.
Amprion says the test is the sole validated seed amplification assay available to help diagnose synucleinopathies associated with Parkinson’s disease and other synucleinopathies, which have historically relied solely on clinical symptoms for diagnosis. Synucleinopathies are neurodegenerative disorders characterized by the abnormal accumulation of alpha-synuclein, a protein that forms toxic clumps in neurons and glial cells, which provide essential support to neurons within the nervous system.
“We are proud to support Amprion and its mission to truly revolutionize brain disease diagnosis and accelerate precision medicine for neurodegenerative disorders,” Rahul Bhansali, managing partner of Formation Venture Engineering, which led the initial round of Series B financing, said in an Amprion press release. “We believe the shift to diagnosis based on biology, rather than symptomology, will be transformative for patients and clinicians. We are excited to support Amprion as they continue to advance their novel technology.”
Parkinson’s disease is characterized by the presence of toxic aggregates of misfolded alpha-synuclein, which are thought to contribute to the progression of the disease. These aggregates spread in a manner similar to prions, where clumps in one area of the brain stimulate the formation of additional aggregates in adjacent regions.
Sensitivity, specificity
Amprion’s assay uses a sample of cerebrospinal fluid, the clear liquid surrounding the brain and spinal cord. A seed of aggregated alpha-synuclein is introduced into the sample to see whether it induces more clumping, simulating the prion-like spread observed in Parkinson’s.
Several studies have confirmed SAAmplify’s high sensitivity and specificity for detecting alpha-synuclein aggregates in the CSF. A test’s sensitivity is its ability to correctly identify those with a given disease, while specificity refers to correctly identifying those without it.
The U.S. Food and Drug Administration (FDA) issued a letter of support recommending scientists and drug developers use a synSAA tool in research and clinical trials aimed at delaying or preventing Parkinson’s and other synucleinopathies.
“We are honored to have FVE and Lilly support our team as we work to advance precision medicine for neurodegenerative disorders,” said Russell Lebovitz, MD, PhD, CEO and co-founder of Amprion. “In addition, the strong interest by leading neurology centers and pharmaceutical companies in our mission is indicative of the confidence they have in our technology and in our vision to bring needed clarity to patients and their loved ones with our novel biomarker test.”
Eli Lilly and Co. and Amprion’s Series A investors also participated in the funding round.