C2N Diagnostics, LLC (C2N) and LSI Medience Corporation (LSIM) today announced a strategic partnership to pursue regulatory approval and commercialization of PrecivityAD2® in Japan, following the test’s recent U.S. FDA clearance1. 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 impairment2. The availability of disease-modifying therapies has further increased the need for accurate, accessible and scalable pathways to evaluate Alzheimer’s disease pathology.

“The emergence of disease-modifying therapies, such as anti-amyloid antibody drugs, in the Alzheimer’s disease therapeutic landscape makes it imperative to evaluate Alzheimer’s disease-related amyloid pathology using accurate, easy-to-use biomarkers. The PrecivityAD2® test will usher in a new era of blood-based evaluation of Alzheimer’s disease-related amyloid pathology, benefiting millions of patients with this devastating brain disorder,” said Takeshi Iwatsubo, M.D., Ph.D., Professor Emeritus, The University of Tokyo.

A New Pathway for Precision Alzheimer’s Diagnostics in Japan

A 1,142-subject clinical validation study supported U.S. FDA clearance of the PrecivityAD2® test3. Accuracy was measured using amyloid PET or cerebrospinal fluid biomarkers as the reference methods to determine the presence or absence of brain amyloid plaques. A Positive PrecivityAD2® result was correct at identifying amyloid 97.6% of the time (positive predictive value), and a Negative result was correct 93.1% of the time (negative predictive value). A Likely Positive result occurred in 17.3% of subjects and showed a 77.3% positive predictive value. Each PrecivityAD2® result category provides medically important information to help health care professionals determine appropriate next steps4.

The PrecivityAD2® test uses high-resolution mass spectrometry to measure two blood biomarker ratios — one related to amyloid (Aβ42/40) and one related to tau protein (%p-tau217) — and combines them into a single score that indicates the likelihood of Alzheimer’s disease-related brain amyloid pathology. The test demonstrated consistent performance across the evaluated clinical stages, age groups, and common chronic disease subgroups included in the clinical validation study.

“U.S. FDA clearance of PrecivityAD2® marked an important milestone for C2N and for blood-based Alzheimer’s evaluation,” said Joel Braunstein, MD, CEO of C2N Diagnostics. “Our collaboration with LSI Medience creates an exciting pathway to pursue Japanese approval and expand future testing access. LSIM’s leadership in clinical diagnostics, together with C2N’s biomarker science, can bring greater clarity to patients, families and clinicians in Japan.”

Kenichi Uchino, President and CEO of LSI Medience Corporation, said, “We are honored to have been selected as a partner of C2N to introduce this important test into clinical settings. We will do our utmost to quickly provide this test to medical institutions, including seeking approval for in vitro diagnostic medical devices in Japan and supporting insurance coverage. LSI Medience has introduced a variety of tests in the field of dementia and provided them to medical institutions. The PrecivityAD2® test has received high praise in numerous academic journals and papers, and we look forward to delivering its benefits to patients through medical institutions.”

Mikio Shoji, M.D., Ph.D., Director, Dementia Center, Geriatrics Research Institute and Hospital, said, “Minimally invasive and reliable blood biomarkers for Alzheimer’s disease are a promising development for diagnosis and treatment of patients suffering from cognitive decline. The partnership agreement between C2N and LSI Medience Corporation could provide substantial scientific contribution to patients and families in Japan.”

Deepening C2N’s Scientific and Commercial Ties With Japan

The LSIM collaboration expands C2N’s existing relationship with PHC Holdings Corporation (TSE 6523), 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 Japan5. 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.

C2N’s ties to Japan also include a strategic relationship with Tokyo-headquartered Eisai. In 2024, Eisai announced an investment of up to $15 million in C2N to support expanded availability, accessibility and use of blood-based Alzheimer’s diagnostics in the United States6. Together with C2N’s scientific collaborations involving Japanese investigators, the relationship reflects Japan’s important role in C2N’s global development.

C2N is also advancing a broader pipeline of blood-based biomarkers addressing Alzheimer’s disease biology. C2N Scientific Co-Founder Randall Bateman, M.D., Eisai scientist Kanta Horie, Ph.D., and international collaborators pioneered the measurement and helped establish the biological role of plasma eMTBR-tau243, a biomarker associated with tau tangle pathology and biological disease staging. Recent studies have evaluated the integration of plasma eMTBR-tau243 with %p-tau217 for scalable biological staging and predicting rate of clinical progression in Alzheimer’s disease7 8.

About C2N Diagnostics, LLC

C2N is a leading specialty diagnostics company with a vision to bring Clarity Through Innovation®. C2N strives to provide exceptional clinical laboratory services and advanced diagnostic solutions in the field of brain health. C2N’s high-resolution mass spectrometry-based biomarker services and products are used for: clinical decision-making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health. C2N assays have been used in over 200 Alzheimer’s disease and other research studies throughout the U.S. and the world. This includes landmark treatment and prevention trials involving disease-modifying therapies (DMTs) that are changing the trajectory of Alzheimer’s disease. Over 90,000 Precivity®-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review.

The company acknowledges generous support from National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, BrightFocus Foundation, Alzheimer’s Association and The Michael J. Fox Foundation. For more information visit https://www.c2n.com.

About LSI Medience

LSI Medience, a Japanese subsidiary of PHC Holdings Corporation (TSE 6523), was established in 1975. With Clinical Testing as its main businesses, LSIM strives to create new solutions by leveraging its power of analytical capabilities developed over many years in various testing fields. Contributing to the prevention, early detection, and treatment of diseases, LSIM is also actively engaged in initiatives to support next-generation medical care, such as personalized medicine.

www.medience.co.jp/english/

About PHC Holdings Corporation (PHC Group)

PHC Holdings Corporation (TSE 6523) is a global collection of healthcare companies with a mission of contributing to the health of society through healthcare solutions that have a positive impact and improve the lives of people. Its subsidiaries (referred to collectively as PHC Group) include PHC Corporation, Ascensia Diabetes Care, Epredia, LSI Medience Corporation, Wemex　Corporation and Mediford Corporation. Together, these companies develop, manufacture, sell and service solutions across diabetes management, healthcare solutions, life sciences and diagnostics. PHC Group’s consolidated net sales in FY2025 were JPY 364.4 billion with global distribution of products and services in more than 125 countries and regions.

www.phchd.com

1 U.S. Food and Drug Administration. 510(k) Premarket Notification: K253240 (PrecivityAD2 Test). Accessed September 9, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253240

2 Cabinet Secretariat of Japan. Research on the prevalence of dementia and mild cognitive impairment and future estimates. Dementia Policy Promotion Stakeholders Meeting, Material 9, May 8, 2024. https://www.cas.go.jp/jp/seisaku/ninchisho_kankeisha/dai2/siryou9.pdf

3 U.S. Food and Drug Administration. 510(k) Premarket Notification: K253240 (PrecivityAD2 Test). Accessed September 9, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253240

4 C2N Diagnostics. PrecivityAD2® U.S. FDA clearance announcement and clinical validation results

5 PHC Group. Mediford and C2N announcement. https://www.phchd.com/global/news/2024/0426

6 Eisai. 2024 investment announcement. https://www.eisai.com/news/2024/pdf/enews202414pdf.pdf

7 Salvado et al. Plasma eMTBR-tau243 and %p-tau217 for biological staging of Alzheimer disease. https://pubmed.ncbi.nlm.nih.gov/42189519/

8 Mattsson-Carlgren et al. Integration of plasma eMTBR-tau243 and p-tau217 in the diagnosis and stratification of Alzheimer’s disease. https://pubmed.ncbi.nlm.nih.gov/41864233/

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