St. Louis, Missouri, USA, and Tokyo, Japan, November 10, 2026
C2N Diagnostics has entered a strategic partnership with LSI Medience Corporation (LSIM) to pursue regulatory approval and future commercialization of its PrecivityAD2® blood test in Japan. Announced on November 10, 2026, the collaboration combines C2N’s expertise in high-resolution mass spectrometry and Alzheimer’s disease biomarkers with LSI Medience’s established clinical laboratory, regulatory, and commercial capabilities in the Japanese healthcare market. The companies aim to support the introduction of blood-based testing that can help healthcare professionals evaluate Alzheimer’s-related amyloid pathology in people experiencing cognitive impairment. The partnership comes as Japan faces a growing need for accessible dementia assessment and diagnostic services. Government-supported estimates cited in the announcement project that approximately 4.72 million people aged 65 and older were living with dementia in Japan in 2025, while another 5.64 million were estimated to have mild cognitive impairment. The increasing availability of disease-modifying Alzheimer’s therapies has also heightened the importance of identifying patients with relevant disease pathology and supporting appropriate clinical evaluation.
C2N and LSI Medience Pursue Japanese Regulatory Approval
Under the agreement, C2N and LSI Medience will work toward obtaining Japanese regulatory approval for PrecivityAD2 and establishing a pathway for its future availability in clinical settings. LSI Medience will contribute its experience in clinical diagnostics, regulatory processes, and commercial operations in Japan. The company also plans to seek approval for the test as an in vitro diagnostic medical device and support efforts related to insurance coverage. PrecivityAD2 has already received U.S. Food and Drug Administration (FDA) 510(k) clearance. In the United States, the test is intended for adults aged 40 years and older who have signs or symptoms of cognitive impairment and are undergoing evaluation for Alzheimer’s disease or other causes of cognitive decline. It is designed to be used alongside clinical assessment by healthcare professionals experienced in evaluating cognitive impairment. Importantly, it is not intended as a standalone diagnostic test or for general population screening. The partnership builds on C2N’s existing connections in Japan. Since 2024, Mediford Corporation, another company within PHC Group, has supported access to C2N’s Precivity testing services for biopharmaceutical and clinical research applications. The new agreement with LSI Medience is intended to complement those research activities by creating a pathway toward regulated clinical diagnostic use.
PrecivityAD2 Uses Blood Biomarkers to Assess Amyloid Pathology
The PrecivityAD2 blood test uses high-resolution mass spectrometry to measure two biomarker indicators associated with Alzheimer’s disease. These are the amyloid-beta 42-to-40 ratio (Aβ42/40) and the percentage of phosphorylated tau protein at position 217 (%p-tau217). The measurements are combined through a proprietary algorithm to generate the Amyloid Probability Score 2, or APS2, which indicates the likelihood of amyloid plaques in the brain. The clinical validation study supporting U.S. FDA clearance included 1,142 participants. Amyloid PET imaging or cerebrospinal fluid biomarkers were used as reference methods to assess the presence or absence of brain amyloid plaques. According to the company, a Positive result had a positive predictive value of 97.6%, while a Negative result had a negative predictive value of 93.1%. A Likely Positive result was reported in 17.3% of participants and had a positive predictive value of 77.3%. These results demonstrate the potential of combining amyloid and tau-related blood biomarkers to provide clinically useful information during Alzheimer’s disease evaluation. The test also showed consistent performance across the clinical stages, age groups, and common chronic disease subgroups included in the validation study. However, predictive values depend on the population and clinical setting, and results must be interpreted in the context of each patient’s overall assessment.
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Japan Partnership Strengthens C2N’s Global Diagnostics Strategy
The collaboration also expands C2N’s broader scientific and commercial relationships in Japan. C2N has an existing strategic relationship with Eisai, which announced an investment of up to $15 million in the diagnostics company in 2024 to support expanded availability and use of blood-based Alzheimer’s diagnostics in the United States. Its collaboration with LSI Medience adds another connection to Japan’s clinical diagnostics and healthcare infrastructure. Beyond PrecivityAD2, C2N is advancing research into additional blood-based biomarkers of Alzheimer’s disease biology. These include plasma eMTBR-tau243, a biomarker associated with tau tangle pathology and biological disease staging. Research has explored its potential combination with %p-tau217 to support biological staging and assessment of disease progression. The agreement represents a further step toward expanding access to blood-based Alzheimer’s diagnostics internationally. While Japanese regulatory approval and commercialization remain future objectives, the collaboration could help establish a new clinical testing pathway for patients and healthcare professionals in Japan. Its progress will depend on regulatory review, clinical implementation, and the development of appropriate access and reimbursement arrangements.
Source: C2N Diagnostics press release
