Collaboration Highlights C₂N’s Growing Global Footprint for Offering Blood Biomarker Research Testing That’s Transforming Clinical Research and Early Diagnosis

C₂N Diagnostics, LLC (“C₂N”), a specialty diagnostics company with a vision to bring Clarity Through Innovation®, today announced a partnership agreement with Mediford Corporation, a PHC Holdings Corporation (TSE 6523) Group Company and premier provider of clinical research to the biopharma industry throughout Japan. The agreement greatly increases access to C₂N Biopharma Clinical Research Services, which offers highly sensitive mass spectrometry-based identification, quantification and monitoring of proteins, protein fragments (peptides) and other biomolecules implicated in human neurological diseases and overall brain health.

The Mediford Corporation alliance means more researchers in Japan can access C₂N’s Precivity™ line of high-performance blood tests that aid in the diagnosis, prognosis, staging, and treatment monitoring of Alzheimer’s disease (AD), including Aβ42/40 and %p-tau217, and other proprietary biomarkers such as those that measure the microtubule-binding domain of tau protein (e.g., MTBR-tau). The company’s latest innovation in the MTBR-tau biomarker intends to uniquely detect the presence and burden of neurofibrillary “tau” tangles (NFTs) comprised of aggregated tau proteins in the brain and as a potential alternative to invasive, costly and often inaccessible tau PET tracers.

C₂N’s expertise in treatment monitoring is highlighted by researchers using its Precivity-Aβ™ blood biomarker in the Clarity AD clinical trial for lecanemab and its Precivity-p-tau217™ blood biomarker in the TRAILBLAZER-ALZ 2 clinical trial for donanemab. As a screening tool to improve the time, efficiency and costs of clinical trial enrollment, C₂N’s blood biomarkers are also being used in the landmark global AD prevention study of AHEAD 3-45, involving evaluation of lecanemab safety and efficacy among individuals at high-risk for future development of clinical AD.

In recognizing wide global interest in its services, C₂N has appointed Maki Hoshiko, Ph.D., as the lead for its Japan strategy and scientific collaborations. Hoshiko, who’s based in Kyoto, Japan, has a well-established background as a neuroscientist focused on the commercialization aspects of the field. She previously served in a similar role with Biogen Inc.

Research Indicates Japanese at High Risk for Alzheimer’s Disease

C₂N’s Japan expansion is occurring as the high-density population country accounted for the second-highest diagnosed prevalent cases of Alzheimer's disease (at 26%) compared to Germany, France, Italy, Spain, the United Kingdom and the United States, according to the “Alzheimer's disease (AD) - Epidemiology Forecast - 2032.” The report states that the country has nearly 4 million diagnosed prevalent cases of Alzheimer's disease. Other research has found that Japan has the highest proportion of people with dementia of any country.

C₂N CEO Dr. Joel Braunstein says, “Japan is a vitally important country in the Alzheimer’s research sector, as both a leading technology innovation hub and also a region of the world where society places a high premium on healthy aging of its citizens. We believe our partnership with Mediford Corporation will unlock many opportunities and possibilities. Mediford Corporation is known for providing clinical and non-clinical analysis that supports each stage of drug research and development, including advanced treatment options. We believe this collaboration provides an excellent pathway to reaching clinical trial researchers and drugmakers searching for the newest treatment solutions and products.”

Mediford Corporation President Mr. Kei Shimizu says, “We’ve closely examined the options for offering blood tests to assess for Alzheimer’s pathology and concluded that C₂N’s blood biomarker testing for clinical trial and treatment monitoring delivers one of the highest standard. C₂N’s assays have been used in over 150 Alzheimer’s disease and other research studies throughout the United States and the world; this includes globally impactful treatment and prevention trials involving disease-modifying therapies that are changing the outlook of Alzheimer’s disease. C₂N’s excellence in quality stands out for its success in developing and commercializing novel diagnostics for Alzheimer’s disease and related forms of neurodegeneration to improve treatment decisions and patients’ lives.”

For researchers in Japan interested in learning more, please contact General Affairs and Human Resource Department of Mediford Corporation at medf-dds-gas@gg.mediford.com.

About C₂N Diagnostics, LLC

C₂N is a 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 150 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. C₂N has ongoing collaborations with multi-national pharmaceutical and biotech companies, leading academic institutions, National Institute on Aging, Alzheimer’s Association, and other non-profits and consortiums. Over 30,000 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 and Alzheimer’s Association. For more information visit www.C2N.com.

About Mediford Corporation

Mediford Corporation is a Japanese subsidiary of PHC Holdings Corporation (TSE 6523). It started drug development support services as the basis business in November 2023 as a member of PHC Group. Mediford Corporation provides comprehensive services for drug development from an exploratory phase of R&D to a clinical development phase. Mediford Corporation strives to enhance its services for pharmaceutical companies and analytical laboratories globally through analytical technologies required in both non-clinical and clinical studies to realize emerging varieties of treatment modality, through collaboration with pharmaceutical/biotech companies and academia in advanced scientific fields. For more information visit www.mediford.com.

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