Unilabs, a Swiss diagnostics company, recently announced a partnership with C2N Diagnostics, a developer of Alzheimer’s disease blood tests. This collaboration aims to distribute C2N’s innovative tests across Europe and selected other regions such as Peru, Saudi Arabia, and the United Arab Emirates. These tests are designed to detect amyloid plaques and neurofibrillary “tau” tangles, which are key indicators of Alzheimer’s disease.
C2N’s primary test in this arrangement is the PrecivityAD, which received a CE mark in 2020, signaling its compliance with European health and safety standards. The test offers a non-invasive method to assess the presence of amyloid beta and tau proteins in the blood, which are associated with mild cognitive impairment and dementia, crucial for diagnosing Alzheimer’s.
The test has shown significant promise in clinical studies, with results published in JAMA in July showing an accuracy rate of 88% to 92% in diagnosing Alzheimer’s among 1,213 patients undergoing cognitive assessments. Moreover, the study highlighted that dementia specialists using the PrecivityAD test could identify Alzheimer’s with 91% accuracy, a notable improvement from the 73% accuracy achieved through traditional methods involving clinical examination, cognitive testing, and CT scans. The accuracy for primary care specialists jumped from 61% to 91% with the use of the test.
The partnership includes plans for a technology transfer, enabling Unilabs to conduct the tests directly in Europe, ensuring that the testing conducted at healthcare institutions there is of the same quality, consistency, and accuracy as that performed in C2N’s lab in Missouri. Further cementing their capacity for advanced diagnostics, Unilabs has also invested approximately 200 million euros in acquiring over 400 laboratory analyzers from Siemens Healthineers in 2023.
This initiative by C2N and Unilabs comes shortly after C2N received significant financial backing, an investment up to $15 million from Eisai, a Japanese pharmaceutical company known for developing the Alzheimer’s drug Leqembi in collaboration with Biogen. This investment aims to enhance test availability in the U.S. and reflects a broader commitment to improving early Alzheimer’s diagnosis processes and increasing access to Alzheimer’s medications recently launched in the market.
Moreover, the efforts to make such diagnostic tests more readily available are part of a larger industry trend. Pharmaceutical giants, including Roche and Eli Lilly, are also focusing on early and more accessible detection of Alzheimer’s. Notably, Roche received FDA breakthrough status for its Elecsys pTau217 plasma biomarker test in April, a product being developed alongside Eli Lilly, signaling a competitive landscape in both the Alzheimer’s diagnostics and therapeutic markets.
The businesses involved hope that by increasing the availability and accuracy of Alzheimer’s diagnostics, they can significantly impact patient care, allowing for earlier and more precise treatment options, which could potentially slow the progression of the disease and improve the quality of life for patients and their families. As the tests roll out in the designated regions in the coming months, this partnership between Unilabs and C2N Diagnostics could mark a significant advancement in the battle against Alzheimer’s disease, offering practical, non-invasive diagnostic solutions that are much-needed in the medical field.
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