Dive Brief:

• Unilabs has struck a deal to distribute C2N Diagnostics’ Alzheimer’s disease blood tests in Europe and certain other regions, the companies said last week.
• C2N has developed blood tests for detecting amyloid plaques and neurofibrillary “tau” tangles, which the company said are “pathological hallmarks of Alzheimer's disease.” The tests provide a non-invasive way to evaluate markers of mild cognitive impairment and dementia.
• The PrecivityAD amyloid plaque test received a CE mark in 2020. Unilabs expects to make C2N tests available to its customers in the coming months.

Dive Insight:

Amyloid PET scans and cerebrospinal fluid testing enable physicians to evaluate amyloid pathology in people who are being assessed for Alzheimer’s. However, the cost, invasiveness and availability of the tests are potential barriers. Diagnostic companies such as C2N claim that accurate, reliable blood tests could improve the diagnostic process and help increase access to recently launched Alzheimer’s medicines.

C2N is developing its Precivity portfolio to target that opportunity. Unilabs, a Swiss company with more than 13,000 employees, has entered into a multi-year agreement to exclusively distribute the tests in Europe, Peru, Saudi Arabia and the United Arab Emirates. The scope of the deal reflects Unilabs’ geographic footprint. 

Researchers published clinical data on PrecivityAD2, one of C2N’s tests, in JAMA in July. The study linked the test, which assesses amyloid beta and tau, to a diagnostic accuracy in a range of from 88% to 92% in 1,213 patients undergoing cognitive evaluation. The study also showed the blood test increased diagnostic accuracy in primary and secondary care: Dementia specialists identified clinical Alzheimer’s disease with an accuracy of 73% after clinical examination, cognitive testing and a CT scan versus 91% when using C2N’s test, and primary care specialists had an accuracy of 61% versus 91%.

The partnership includes technology transfer plans that will position Unilabs to run tests in Europe. The goal is to perform Precivity testing at qualified healthcare institutions with the same quality, consistency and accuracy as C2N’s lab in Missouri. In 2023, Unilabs agreed to buy more than 400 laboratory analyzers from Siemens Healthineers for 200 million euros. 

C2N’s deal with Unilabs comes five months after it received an up to $15 million investment from Eisai, the Japanese drugmaker that developed the Alzheimer’s drug Leqembi with Biogen. The investment was intended to improve the availability of tests for the early diagnosis of Alzheimer’s in the U.S.

The push to expand access to Precivity tests in the U.S. and overseas is part of a broader effort to diagnose Alzheimer’s earlier. Roche is among the companies active in the area and received FDA breakthrough status for its Elecsys pTau217 plasma biomarker test in April. The Swiss company is developing the test with Eli Lilly, which rivals Eisai and Biogen in the Alzheimer’s drug market.