CN2 Diagnostics, Unilabs Collaborate on Alzheimer’s Disease Biomarker Testing

Unilabs and C2N Diagnostics LLC are teaming up to strengthen brain health diagnostics and research in parts of Europe, the Middle East, and South America.
 
Unilabs and C2N have signed a multi-year partnership agreement that will increase access to C2N’s Precivity blood test portfolio 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,” Unilabs’ Head of Innovation Dr. Rahul Chaudhary said. “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. C2N’s Precivity portfolio of blood tests and its biomarker pipeline offer the highest performance precision tools in the industry. 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 help healthcare providers and researchers in detecting 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 throughout 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.
 
C2N’s PrecivityAD blood test gained CE Mark approval in 2020, andit  also has In Vitro Diagnostic Regulation legacy device status under Regulation (EU) 2017/746, which allows for commercial availability in the European Union as an in-vitro diagnostic to assist in evaluating 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 help diagnose Alzheimer’s disease.
 
“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,” C2N CEO Dr. Joel Braunstein said. “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 found in the blood that are known to be associated with 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. The tests are intended for use in patients 55 years and older with signs or symptoms of mild cognitive impairment or dementia. 
 
C2N and Unilabs expect the Precivity portfolio of blood tests will become available to Unilabs customers over the coming months, depending on geographic region. 
 
C2N is a specialty diagnostics company providing clinical laboratory services and advanced diagnostic solutions in the brain health field. 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 more than 150 Alzheimer’s disease and other research studies throughout the United States 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. More than 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 has a non-exclusive agreement with Mayo Clinic Laboratories. The company has received support from National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, Alzheimer’s Association, and BrightFocus Foundation. 
 
Unilabs is an international provider of diagnostic services offering a complete range of laboratory, pathology, genetics and imaging services to patients across four continents. With more than  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 annually.