C2N Diagnostics and Unilabs Announce Global Partnership, Bringing Together Innovation Leaders in Diagnostics and Laboratory Medicine to Advance Brain Health

ST. LOUIS & GENEVA, Switzerland--(BUSINESS WIRE)--Aug 7, 2024--

Unilabs (“Unilabs”), a leading international provider of diagnostic services, and C2N Diagnostics, LLC (“C2N”), a pioneer in advanced diagnostic solutions in the field of Alzheimer’s disease (AD) and related neurological disorders, today announced a major milestone in brain health diagnostics and research across Europe and beyond.

Unilabs and C2N have signed a multi-year partnership agreement that will increase access to C2N’s Precivity portfolio of blood tests on an exclusive basis in Europe, including Norway, Switzerland, and the United Kingdom. The agreement will also provide access in Peru, Saudi Arabia, and the United Arab Emirates.

“Alzheimer's disease is on the rise, making it essential to innovate by offering less invasive and more accessible diagnostic procedures for patients,” said Unilabs’ Head of Innovation Dr. Rahul Chaudhary. “All too often, diagnosing Alzheimer's has been painful, invasive and expensive. This partnership will transform the diagnostic experience for patients with cognitive concerns while revolutionizing early diagnosis, and research efforts, and positively impacting long-term outcomes.”

He continued, “C2N’s Precivity portfolio of blood tests and its innovative biomarker pipeline offer the highest performance precision tools in the industry 1. We expect these innovations to appeal to healthcare providers in Europe, the Gulf Region and Latin America who rely on us, and to our biopharma collaborators who are developing new therapies. Patients worldwide deserve access to an early diagnosis, leveraging personalized medicine tools that can enable better treatment decisions and activate long-term disease prevention strategies. We are confident these tests can help in achieving better outcomes for patients, as we continue in our mission to power health and maximize life.”

C2N’s Precivity portfolio of blood tests aid healthcare providers and researchers in the detection of amyloid plaques and neurofibrillary “tau” tangles in the brain, which are pathological hallmarks of Alzheimer's disease. These tests also help to inform medical management and treatment decisions based on the underlying causes of dementia.

This strategic partnership also plans to facilitate a technology transfer of C2N’s proprietary portfolio of Alzheimer’s blood biomarkers to deliver a Unilabs testing network across Europe, ensuring Precivity testing can be performed at qualified healthcare institutions with the same quality, consistency and accuracy currently delivered at C2N’s central CAP/CLIA lab in St. Louis, Mo.

Both companies believe this partnership will transform global Alzheimer’s disease diagnosis for patients with cognitive concerns or at high risk of future AD or AD-related dementias.

Healthcare Sector Eager for Easy-to-Access, Less Invasive Tests

C2N previously announced in 2020 that the PrecivityAD® blood test achieved the CE Mark from the European Union (EU) and also has In Vitro Diagnostic Regulation legacy device status under Regulation (EU) 2017/746, which allows for commercial availability in the EU as an in vitro diagnostic to aid in the evaluation of patients with mild cognitive impairment or dementia. In addition, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency approved the PrecivityAD blood test as an in vitro diagnostic to aid in the diagnosis of Alzheimer's disease.

C2N CEO Dr. Joel Braunstein said, “The sobering impact of Alzheimer’s disease reaches beyond any one country’s borders and that’s why it’s vital we respond to the global interest in our Precivity blood tests. We believe this collaboration allows for the acceleration of equitable access to the highest quality blood biomarkers that can aid in the diagnosis of Alzheimer’s disease. To date, we’ve secured other international arrangements, and now, we’re very proud to enter this multi-faceted strategic affiliation with Unilabs, an organization that places a premium on quality in testing and in personalized diagnostics for Alzheimer’s disease.”

The PrecivityAD2™ and PrecivityAD blood tests use highly sensitive and specialized laboratory technologies to identify and measure certain proteins that are found in the blood and that are known to be associated with the presence of brain amyloid plaques, one of the brain pathology findings of Alzheimer’s disease. The main test result is a clinically validated score that determines a patient’s likelihood category for the presence of brain amyloid plaques. Like other tests that evaluate for brain amyloid pathology in clinical patients, such as amyloid PET scan or cerebrospinal fluid (CSF) testing, the Precivity blood tests can be used by healthcare providers to interpret the test results, along with other medical information.

The tests are intended for use in patients 55 years and older with signs or symptoms of mild cognitive impairment or dementia. These tests are only available for order by qualified healthcare providers.

C2N and Unilabs expect the Precivity portfolio of blood tests will become available to Unilabs customers over the coming months, depending on geographic region. To inquire further about timelines for a specific country please email globalinfo@c2n.com or globalinfo@unilabs.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. C2N has partnered with numerous leading clinical diagnostic labs throughout the world to offer expanded Precivity™ testing access to providers and patients, including Grupo Fleury in Brazil and Healius Pathology in Australia for clinical use, and with Mediford Corporation in Japan for research purposes. C2N also recently announced it has entered into a non-exclusive agreement with Mayo Clinic Laboratories.

The company acknowledges generous support from National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, Alzheimer’s Association and BrightFocus Foundation. For more information visit www.C2N.com.

About Unilabs

Unilabs is a leading international provider of diagnostic services offering a complete range of laboratory, pathology, genetics and imaging services to patients across four continents.

With over 13,000 people in 15 countries, Unilabs invests heavily in technology, equipment and people — using digital technologies in its state-of-the-art laboratories and imaging institutes — to improve the lives of close to 100 million people every year. For more information visit www.unilabs.com

Key publications on the Precivity Portfolio of Tests, more atwww.precivityad.com/publications-clinical-use.

PrecivityAD2

• Palmqvist S, Tideman P, Mattsson-Carlgren N, et al. Blood Biomarkers to Detect Alzheimer Disease in Primary Care and Secondary Care.JAMA, 2024. https://doi:10.1001/jama.2024.13855
• Matthew R. Meyer, Kristopher M. Kirmess, et.al. Clinical validation of the PrecivityAD2 blood test: A mass spectrometry-based test with algorithm combining %p-tau217 and Aβ42/40 ratio to identify presence of brain amyloid.Alzheimer’s Dement, 2024.https://doi.org/10.1002/alz.13764

PrecivityAD

• Hu Y, Kirmess KM, Meyer MR, et al. Assessment of a plasma amyloid probability score to estimate amyloid positron emission tomography findings among adults with cognitive impairment. JAMA Netw Open. 2022; 2022. doi:10.1001/jamanetworkopen.2022.8392
• Fogelman I, West T, Braunstein JB, et al. Independent study demonstrates amyloid probability score accurately indicates amyloid pathology.Ann Clin Transl Neurol, 2023. doi.org/10.1002/acn3.51763
• Monane MM, Johnson KG, Snider, BJ, et al. A blood biomarker test for brain amyloid impacts clinical decision making among memory specialists in the evaluation of cognitive impairment.Ann Clin Transl Neurol, 2023 .http://doi.org/10.1002/acn3.51863
• Canestaro et al, Use of a Blood Biomarker Test Improves Economic Utility in the Evaluation of Older Patients Presenting with Cognitive Impairment; Population Health Management, 2023.https://doi.org/10.1089/pop.2023.0309

Head-to-head technology comparisons of blood biomarkers for Alzheimer’s disease1

• Janelidze et al . Head-to-head comparison of 10 plasma phosphor-tau assays in prodromal Alzheimer’s disease.Brain, 2023. https://doi.org/10.1093/brain/awac333
• Janelidze et al. Head-to-head comparison of 8 plasma amyloid-beta 42/40 assays in Alzheimer’s disease. JAMA Neurology, 2021. https://jamanetwork.com/journals/jamaneurology/fullarticle/2784411
• Schindler, et al. Effect of Race on Prediction of Brain Amyloidosis by Plasma Aβ42/Aβ40, Phosphorylated Tau, and Neurofilament Light.Neurology, 2022. https://doi.org/10.1212/WNL.0000000000200358

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CONTACT: For C2N DiagnosticsCOMPANY CONTACT:Joni Henderson

JHenderson@c2n.com

314-464-0009MEDIA CONTACT:Adam Shapiro

Adam.Shapiro@ASPR.bz

202-427-3603For UnilabsUnilabs Press Officepressoffice@unilabs.com

KEYWORD: EUROPE SWITZERLAND UNITED STATES NORTH AMERICA MISSOURI

INDUSTRY KEYWORD: MEDICAL SUPPLIES BIOTECHNOLOGY HEALTH SENIORS PHARMACEUTICAL NEUROLOGY MENTAL HEALTH HEALTH TECHNOLOGY RESEARCH CONSUMER SCIENCE

SOURCE: C2N Diagnostics, LLC

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PUB: 08/07/2024 08:07 AM/DISC: 08/07/2024 08:06 AM

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