GCCL launches Korea’s 1st α-Synuclein biomarker test, expanding Parkinson’s diagnostics

Global Clinical Central Lab (GCCL) has launched Korea’s first commercial biomarker analysis service for Parkinson’s disease, expanding diagnostic capabilities for neurodegenerative disorders.

The company announced Tuesday that it has successfully developed and commercialized an analytical method for detecting alpha-synuclein (αSyn), a key biomarker for Parkinson’s and related conditions.

Parkinson’s disease is characterized by the abnormal accumulation of αSyn in neurons, leading to motor impairments and cognitive decline. The αSyn seed amplification assay (SAA) has emerged as a critical tool for detecting misfolded αSyn in cerebrospinal fluid (CSF), offering greater accuracy than traditional immunoassays.

While this technology has been recognized in updated Alzheimer’s diagnostic guidelines by the U.S. National Institute on Aging and the Alzheimer’s Association, it has not been available in Korea until now.

GCCL's new service fills that gap. Developed in-house by its R&D division, a GCCL official said the αSyn-SAA method extends beyond Parkinson’s, aiding research on multiple system atrophy, dementia with Lewy bodies, and other neurodegenerative diseases. "By amplifying and detecting abnormal protein aggregates, the method enables more precise differentiation of disorders like Alzheimer’s and other neurological conditions," the official added.

The company has validated its method using CSF and brain homogenates in central nervous system (CNS) disease research, allowing pharmaceutical firms to conduct more precise biomarker-based studies and drug development.

GCCL plans to present its findings at the CLEVERcns seminar at Seoul National University Hospital on March 26.

“This advancement strengthens Korea’s capabilities in neurodegenerative disease research and drug development,” said CEO Cho Kwan-goo. “Accurate biomarker analysis is crucial to improving the success rate of new treatments for CNS diseases, and we aim to set a global benchmark in clinical analysis services.”

GCCL, a Korean clinical trial sample analysis organization established in 2019, is a joint venture of GC Labs, GC Cell, and CRO C&R Research. Holding Good Clinical Laboratory Practice (GCLP) certification, the company provides analytical method development and sample analysis across all clinical trial phases, using internationally recognized platforms such as digital droplet PCR (ddPCR).