The funding will help create a distributed clinical mass spectrometry system to improve the efficiency of Alzheimer’s disease diagnostics. Credit: Peakstock / Shutterstock.com.

C2N Diagnostics has received an investment of up to $7.025m from the Alzheimer’s Drug Discovery Foundation’s Diagnostics Accelerator for its Alzheimer’s disease testing platform.

This funding will support the development of a decentralised clinical mass spectrometry solution to enhance the global accessibility and performance of Alzheimer’s disease testing.

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It will enable C2N to advance its high-resolution liquid chromatography-mass spectrometry (LC-MS) platform. The platform will help deploy the company’s clinical and research biomarkers in local clinical labs worldwide, facilitating early detection and diagnosis of Alzheimer’s disease.

The end-to-end platform will encompass instruments and diagnostic kits, allowing research and clinical labs worldwide to detect fluid biomarkers indicative of Alzheimer’s disease brain pathologies.

This project will include multiple assays that monitor amyloid and tau pathology, with a structure to integrate future C2N assays for different neuropathologies.

The decentralised approach, developed in compliance with regulatory standards, is designed to meet the increasing demand for early and precise disease detection.

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Running parallel to the global scalability project, the C2N project continues to offer its Precivity tests at its St Louis laboratory, a CLIA-certified and CAP-accredited facility.

C2N CEO Dr Joel Braunstein said: “We believe the potential reach of our scale-up achievable through an LC-MS clinical analyser that can run our proprietary portfolio of Precivity tests is significant.

“Many research and clinical labs at locations throughout the world have already expressed interest in adopting our tests.”

The announcement coincides with World Alzheimer’s Month and follows other strategic partnerships, including an exclusive agreement with Unilabs to expand access to C2N’s Precivity blood tests in Europe, Peru, Saudi Arabia, and the UAE, as well as a non-exclusive agreement with Mayo Clinic Laboratories.

In 2018, C2N received breakthrough device designation from the US Food and Drug Administration, reinforcing its status as a preferred diagnostics provider for biopharmaceutical companies globally.

C2N signed an agreement with diagnostic services provider Unilabs last month to expand access to its Precivity portfolio of Alzheimer’s blood tests in more than 75 countries.