JOINN Clinical Testing and Hangzhou Newland Technology Strategic Cooperation to Lead the Innovation of Neurological Disease Detection Technology

February 26, 2025 — JOINN Clinical Testing, a globally leading clinical testing organization, has signed a strategic cooperation agreement with Hangzhou Neoline Technology Co., Ltd. Leveraging Single Molecule Array (Simoa®) technology, both parties will focus on biomarker research for neurodegenerative and neuroimmune diseases to accelerate drug R&D and clinical translation, delivering end-to-end solutions for pharmaceutical clients worldwide.

Technology Breakthrough: Simoa® Transforms Disease Diagnosis and Management

Developed by a research team at Harvard University, Simoa® achieves femtogram-level (fg/mL) sensitivity, representing a 3-order-of-magnitude improvement over conventional ELISA. It enables precise quantification of ultra-low-abundance protein biomarkers in blood samples. Its core value lies in:

Early Warning: Detecting biomarkers including Aβ42/40, pTau217 and NFL to identify the progression of diseases such as Alzheimer's disease (AD) at an earlier stage.

Precision Drug Development: Supporting clinical trials of targeted therapeutics including Eisai's Lecanemab and Eli Lilly's Donanemab, optimizing patient selection and efficacy assessment.

Dynamic Monitoring: Evaluating treatment responses for multiple sclerosis (MS), ALS and other conditions using markers such as NFL.

Quanterix HD-X

Serving Pharmaceutical Clients: End-to-End Empowerment for Drug R&D

The partnership is tailored to meet the demands of pharmaceutical sponsors, covering the full lifecycle from early discovery through post-launch phases:

1. Precision Enrollment and Patient Stratification

Deploy Simoa® assays to measure biomarkers including Aβ42/40 and pTau181 for rapid screening of eligible trial participants and improved clinical trial efficiency.

Integrate AI algorithms for biomarker panel analysis to support personalized therapeutic regimen design.

2.Efficacy Assessment and Dose Optimization

Dynamically monitor markers such as NFL and GFAP to evaluate drug safety and efficacy in real time and shorten clinical development timelines.

Conduct longitudinal cohort studies to validate correlations between biomarkers and clinical endpoints, mitigating the risk of Phase III trial failures.

3.Companion Diagnostic Development

Co-develop Simoa®-based assay kits to enable companion diagnostics for targeted agents (e.g., α-synuclein oligomers).

Deliver testing services compliant with international standards set by FDA, EMA and other regulators to expedite global registration.

4.Data-Driven Decision Support

Build a biomarker database for neurological disorders, offering multi-dimensional data analytics and predictive modelling for pharmaceutical companies.

Draw on learnings from successful cases such as Biogen's Tofersen (ALS therapy) to reduce blind spots in R&D.

Partnership Strengths: Dual-Driven by Technology and Resources

JOINN Clinical Testing: Operates GLP/GCP/GCLP/CNAS-accredited compliant laboratories in Beijing and Suzhou. It has completed over one hundred drug trials and serves leading domestic and global pharmaceutical enterprises.

Hangzhou Neoline Technology Co., Ltd.: Specializes in translational research of protein biomarkers. It provides the fully automated Simoa HD-X platform and custom services, and has supported dozens of pharma firms in biomarker validation.

Strategic Priorities: Three Core Focus Areas

1. Alzheimer's and Parkinson's Diseases: Establish standardized testing workflows for Aβ42/40, pTau181 and other analytes; explore novel biomarkers including α-synuclein oligomers.

2. Multiple Sclerosis and Neuroimmune Disorders: Develop high-sensitivity NFL assays and investigate immune microenvironment regulation alongside inflammatory cytokines IL-6 and CXCL13.

3. Biomarker Repository Development: Jointly launch large-scale cohort studies and build a neurological disease database powered by Simoa® technology.

Ecosystem Co-creation for Global Collaborative Growth

The two parties will carry out in-depth cooperation around the following objectives:

Technology Sharing: JOINN leverages its extensive laboratory network to deliver compliant testing services to pharma clients; Neoline supplies the fully automated HD-X platform and comprehensive technical backing.

Joint Project Delivery: Co-apply for research grants and co-develop diagnostic kits and companion diagnostic products.

Ecosystem Building: Promote standardized adoption of Simoa® technology across cerebrospinal fluid, blood and other matrices; author industry white papers and technical guidelines.

Future Outlook

Dr. Kaitong Li, Chief Scientific Officer of JOINN Clinical Testing, commented: "This collaboration deeply integrates Simoa® technology with JOINN's clinical research capabilities. We aim to deliver earlier, more precise diagnostic and therapeutic solutions for patients worldwide, while helping pharmaceutical partners break through R&D bottlenecks and accelerate the launch of innovative medicines."

Hu Jun, General Manager of Hangzhou Neoline Technology Co., Ltd., emphasized: "JOINN's extensive experience in neurological drug development creates the ideal real-world setting for Simoa® technology implementation. Together we will build a 'technology + service' ecosystem to drive comprehensive breakthroughs for neurological diseases spanning molecular mechanisms through clinical treatment.”


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