Thanks to additional research funding from NIH/NINDS, Amprion joins the world’s heightened focus during Alzheimer’s & Brain Health Awareness Month by expanding its quantitative study of a one-of-a-kind biomarker test to detect alpha-Synuclein pathology in Parkinson’s Disease and may also help improve the diagnosis of other synucleinopathies, including Lewy Body Dementia and underlying synucleinopathy in Alzheimer’s Disease.
Amprion announces the National Institute of Neurological Disorders and Stroke (NINDS) has awarded an additional research grant of approximately $730,000 for continued validation of the SYNTap Biomarker Test (total award: $1.6 million, grant number: 5U44NS111672-03).
The research funds will be used to validate the quantitative adaptation of the SYNTap Biomarker Test, which detects misfolded α-Synuclein aggregates, a hallmark of synucleinopathies including underlying synuclein pathology in Alzheimer’s Disease, Mild Cognitive Impairment (MCI), Lewy Body Dementia (LBD), Multiple System Atrophy (MSA), and Parkinson’s Disease (PD).
The company expects research results to provide breakthrough insights to help accelerate the innovation of precision medicine for neurodegenerative diseases.
Why is validated biomarker testing for brain diseases so important? Consider this: More than 50 million people worldwide are affected by neurological conditions, including Alzheimer’s, Lewy Body Dementia, and Parkinson’s. This staggering number is rising, as 18 million new cases are added each year.
Historically, it has been challenging to diagnose different variants of Alzheimer’s Disease and Alzheimer’s Disease Related Dementias. The overlapping symptoms, especially in the early stages, often cause misdiagnosis, hindering effective treatment plans.
“There is a critical need to develop biomarker tests that will aid accurate diagnosis for early detection and simultaneously speed the research and development of biomarker-targeted therapeutics,” remarked neuroscientist Claudio Soto, Ph.D., chief scientific officer and co-founder of Amprion. “While many biomarker tests have been proposed in the research community, very few can pass the rigorous process used to validate analytical and clinical usefulness. We are pleased to receive NINDS’ grant support to achieve these paramount objectives,” added Dr. Soto.
Upon receiving news on the research funding, Russ Lebovitz, MD, Ph.D., Amprion CEO, echoed, “A confident diagnosis helps doctors optimize personal treatment and management strategies. In addition, the advent of molecular testing sheds new light on R&D of biomarker-targeted drugs for precision medicine.”
Amprion performs the SYNTap Biomarker Test in its CLIA-certified, CAP-accredited clinical lab in San Diego (CLIA ID 05D2209417; CAP # 8168002). Download the SYNTap Test Performance Characteristics to learn more.
Amprion is working to obtain FDA approval for the SYNTap Biomarker Test and expand test rollout internationally. On the drug R&D front, we are actively exploring strategic BioPharma partnerships to advance biomarker-targeted drugs and therapeutics for precision medicine.
ABOUT THE NIH GRANT
The purpose of this Funding Opportunity Announcement (FOA) is to support applications from Small Business Concerns (SBCs) to perform rigorous analytical validation of candidate biomarker measures or endpoints in a manner that is consistent with FDA guidelines. Analytical validation establishes that the performance characteristics of the biomarker measurement or endpoint are acceptable for its intended use. This FOA aims to facilitate the advancement of robust and reliable biomarkers of diseases that fall within the mission of NINDS to application in clinical trials and practice (Phase II clinical trials and beyond). Learn more here: https://grants.nih.gov/grants/guide/pa-files/PAR-18-549.html.
A leader in Prion Detection Science™, Amprion innovates biomarker testing for brain diseases. Our SYNTap® Biomarker Test helps doctors diagnose Lewy Body Variant of Alzheimer’s Disease, Parkinson’s Disease, and Lewy Body Dementia. Awarded FDA Breakthrough Device Designation for its detection technology, Amprion strives to accelerate precision medicine for neurodegenerative diseases through molecular testing.