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C2N Diagnostics, LLC and LSI Medience Corporation (LSIM) have announced a strategic partnership to pursue regulatory approval and commercialisation of PrecivityAD2® in Japan, following the test’s recent US FDA clearance. The collaboration combines C2N’s expertise in high-resolution mass spectrometry and Alzheimer's diagnostics with LSIM’s established clinical laboratory, regulatory and commercial capabilities in Japan.
In the United States, PrecivityAD2® is FDA cleared for adults aged 40 years and older who present with signs or symptoms of cognitive impairment undergoing evaluation for Alzheimer’s disease or other forms of cognitive decline. The test is intended to be used in conjunction with clinical assessment to aid health care professionals experienced in evaluating cognitive impairment to identify patients with amyloid pathology associated with Alzheimer’s disease. The test is not intended as a screening or stand-alone diagnostic test.
The partnership comes at an important time for Alzheimer’s care in Japan. Japanese government-supported estimates project that approximately 4.72 million people aged 65 and older in Japan are living with dementia in 2025, with another 5.64 million experiencing mild cognitive impairment.
The LSIM collaboration expands C2N's existing relationship with PHC Holdings Corporation, known collectively with its subsidiaries as PHC Group in Japan. Since 2024, fellow PHC Group company Mediford Corporation has supported access to C2N’s Precivity® testing services for biopharmaceutical and clinical research applications in Japan. The addition of LSIM as a partner creates a complementary pathway toward regulated clinical diagnostics by combining C2N’s technology with PHC Group’s research, laboratory, regulatory and commercial capabilities.
