C2N Diagnostics, LSI Medience Seek Japan Approval for Alzheimer’s Test
C2N Diagnostics and LSI Medience announced a partnership to pursue Japanese regulatory approval and commercialization of PrecivityAD2, a blood test used in the United States to help evaluate Alzheimer’s-related brain amyloid pathology. The companies said the collaboration combines diagnostic science with LSI Medience’s laboratory and regulatory capabilities in Japan.
C2N Diagnostics and LSI Medience announced a partnership on November 10, 2026, to seek Japanese regulatory approval and commercialize the PrecivityAD2 Alzheimer’s blood test. The plan could bring a U.S.-cleared tool for evaluating Alzheimer’s-related brain amyloid pathology to clinical settings in Japan.
The companies said the collaboration pairs C2N’s mass spectrometry and Alzheimer’s diagnostic expertise with LSI Medience’s clinical laboratory, regulatory and commercial capabilities in Japan. They have not announced a timeline for approval or launch.
In the United States, PrecivityAD2 is cleared for adults aged 40 years and older who have signs or symptoms of cognitive impairment and are being evaluated for Alzheimer’s disease or other cognitive decline. The test is intended to support clinical assessment by health professionals experienced in evaluating cognitive impairment.
It is not intended for screening or use as a stand-alone diagnostic test.
The test measures two blood biomarker ratios, one related to amyloid and the other to tau protein, using high-resolution mass spectrometry. It combines them into a score indicating the likelihood of Alzheimer’s-related brain amyloid pathology.
A clinical validation study involving 1,142 subjects supported the U.S. clearance. The study used amyloid PET or cerebrospinal fluid biomarkers as reference methods. 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 occurred in 17.3% of subjects and had a positive predictive value of 77.3%. The company said each result category can help health professionals decide on appropriate next steps.
Japanese government-supported estimates cited in the announcement project that approximately 4.72 million people aged 65 and older in Japan were living with dementia in 2025, with another 5.64 million experiencing mild cognitive impairment. The announcement said the availability of disease-modifying therapies has increased demand for ways to evaluate Alzheimer’s-related pathology.
“U.S. FDA clearance of PrecivityAD2 marked an important milestone for C2N and for blood-based Alzheimer’s evaluation,” said Joel Braunstein, chief executive officer of C2N Diagnostics. He said the partnership creates a pathway to pursue Japanese approval and expand future testing access.
Kenichi Uchino, president and chief executive officer of LSI Medience, said the company would work to provide the test to medical institutions, including by seeking regulatory approval.
