Blood test may help detect early Parkinson’s-related protein misfolding
iRS platform is being developed as a possible early detection tool
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- German researchers developed an iRS blood test that may help support earlier Parkinson’s detection.
- The test is designed to identify misfolded alpha-synuclein, a protein linked to Parkinson’s disease.
- The technology could one day support earlier diagnosis and treatment decisions, but regulatory approval is needed before public use.
A team of researchers in Germany has developed an immuno-infrared sensor (iRS) designed to detect misfolded alpha-synuclein, a protein linked to Parkinson’s disease, in body fluids including blood and the fluid that surrounds the brain and spinal cord. The researchers say the technology could one day support earlier diagnosis, potentially before symptoms appear.
The team is led by Klaus Gerwert, PhD, professor at Ruhr University Bochum and founder and CEO of Betasense. The company is using iRS in clinical studies, and studies have shown the platform can detect disease-related alpha-synuclein misfolding in body fluids.
According to Grischa Gerwert, the paper’s first author, this technology may have broad applications for analyzing a wide variety of molecules in complex solutions. “This method holds promise for broad clinical application and population-wide screening in the future,” Grischa said in a university news story.
The paper, “An Immuno-Infrared Sensor Detects Preclinical Alzheimer’s and Parkinson’s Disease by Protein Misfolding,” was published in The Journal of Physical Chemistry B.
Why alpha-synuclein matters in Parkinson’s
In Parkinson’s, misfolded alpha-synuclein forms oligomers – early clumps of the protein – that can aggregate into fibrils deposited in Lewy bodies. Alpha-synuclein clumps are thought to contribute to nerve cell damage linked to the disease’s symptoms. Misfolded forms of alpha-synuclein also can be detected in body fluids, including blood and cerebrospinal fluid, or CSF, the liquid that surrounds the brain and spinal cord.
Diagnosis is largely based on motor symptoms, including slowed movement, rigidity, and tremor, which usually appear after substantial nerve cell damage. While therapies can ease Parkinson’s symptoms, earlier diagnosis could help support earlier treatment and future therapeutic strategies.
“Because of this, there is a broad consensus in the scientific community that therapy needs to begin much sooner, even before the typical insoluble protein deposits form in the brain,” Klaus Gerwert said.
iRS was developed using specific antibodies attached to the sensor with a patented surface chemistry to isolate misfolded proteins, including alpha-synuclein, from body fluids. It allows measurement of the degree of alpha-synuclein misfolding, addressing the need for a non-invasive, cost-effective blood test.
The sensor can distinguish alpha-synuclein monomers, oligomers, and fibrils based on where each form absorbs infrared light. During the alpha-synuclein aggregation process, from monomers to oligomers and fibrils, this infrared signal shifts, indicating increasing protein misfolding.
Studies tested iRS in CSF and blood
In a previously published study, the same team analyzed the use of the iRS platform in CSF samples from two groups: people with Parkinson’s or multiple system atrophy (MSA), a form of atypical Parkinsonism, and controls. The platform distinguished the Parkinson’s and MSA samples from controls based on alpha-synuclein misfolding.
Similar results were seen in another study, posted as a preprint and not yet peer reviewed, that tested the iRS platform in blood serum samples from people with Parkinson’s and related alpha-synuclein disorders, compared with controls.
According to the researchers, the iRS platform may complement alpha-synuclein seed-amplification assays (SAAs), which can detect misfolded forms of alpha-synuclein in CSF. SAAs are based on the ability of abnormal alpha-synuclein to act as a seed that triggers clumping of normal alpha-synuclein.
The technology can also be used to detect misfolded proteins in other neurodegenerative diseases, including Alzheimer’s disease.
For the test to be available as an early detection tool for the general public in Europe, approval under the European In Vitro Diagnostic Regulation (IVDR) is required. If marketed in the U.S., it also would need appropriate review by the U.S. Food and Drug Administration (FDA). Both regulatory systems oversee the development, manufacturing, and clinical use of diagnostic medical devices.
“At Betasense, we are working hard to advance the approval process and make the test available to the public as soon as possible,” Grischa Gerwert said.
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