Breakthrough biomarker test aids physicians in diagnosing synucleinopathies by detecting misfolded Synuclein aggregates in cerebrospinal fluid (CSF). Alpha-Synuclein is a misfolded protein associated with PD, LBD, and AD. Molecular diagnosis accelerates precision medicine for treating neurodegenerative diseases.
San Francisco, CA (PRWEB) - Amprion has announced the commercial rollout of its innovative SYNTap Biomarker Test, a first-in-class laboratory-developed test (LDT) for accurate and reliable detection of α-synuclein aggregates, a hallmark in various brain diseases.
The SYNTap Test aids in diagnosing synucleinopathies such as Parkinson's, Lewy Body Dementia, and Multiple System Atrophy (MSA). In addition, the novel test helps distinguish underlying synucleinopathies in other neurodegenerative conditions, such as Alzheimer's. Based on Amprion's proprietary technology, Seed Aggregation Assay (SAA), the SYNTap Test identifies prion-like α-synuclein aggregates using a few drops of CSF (about one hundred microliters), confirming the presence of progressive brain disease. Test results are intended to accompany other clinical and diagnostic findings for patient case management.
"Before the SYNTap Test, there has been no specific, objective laboratory test for the diagnosis of neurodegenerative diseases such as PD, LBD, and MSA. Traditionally, patients are diagnosed based on clinical symptoms, which means their disease is relatively advanced," said Amprion Co-founder and Chief Scientific Officer Claudio Soto, Ph.D. "Our technology detects the prion biomarkers in CSF samples years before patients show symptoms. Such early diagnosis is crucial because it enables physicians to steer their patients to proper treatments.” In addition, patients can make lifestyle changes early when their brain is healthier and more responsive to intervention. Until now, early diagnosis was not an option.
"Brain diseases affect individuals differently. For instance, ten patients can have ten different biomarker profiles," said Dr. Russell Lebovitz, MD, Amprion CEO and co-founder. "Symptoms often overlap, leading to misdiagnosis 40 to 50% of the time. In addition, diagnosis significantly impacts drug treatment as wrongly prescribed medication can harm patients instead of helping them. The SYNTap Test provides physicians a molecular tool to greatly improve diagnostic accuracy. This is vital because personalized medicine is the key in treating neurodegenerative disorders.”
Recently awarded a US FDA Breakthrough Device Designation, Amprion's prion detection research has been supported by the National Institutes of Health under award numbers 1R42AG058333 and 1U44NS111672, Alzheimer's Drug Discovery Foundation (ADDF), The University of Texas McGovern Medical School, and The Michael J. Fox Foundation.
Performed exclusively at Amprion's CLIA-registered laboratory in San Diego, California, the SYNTap Test is available throughout the US except for Maryland, New York, Pennsylvania, and Rhode Island. Market rollout in these states is expected within the next six months.
Currently, 5.8 million people are diagnosed with Alzheimer's in the US annually, 1.4 million with LBD, and 1.5 million with Parkinson's, adding to the millions already suffering from these diseases without a cure. And these numbers are expected to triple by 2050.
"Our ultimate goal is to find a cure for brain diseases. Now that we can accurately detect the biomarker early, we'll make great strides to accelerate research and innovation. Amprion is on a mission to advance personalized medicine through biomarker testing," said Dr. Lebovitz.
To order the SYNTap Biomarker Test, doctors can register online. For more information, please visit Amprion’s Physicians Center.
A leader in prion detection research, Amprion innovates biomarker testing, enabling doctors to accurately diagnose Parkinson's, Lewy Body Dementia, and other synucleinopathy. The test identifies misfolded protein aggregates driving various neurodegenerative conditions at all stages. The company anticipates rolling out other biomarker tests, including abeta and tau.