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Unilabs, a leading international provider of diagnostic services, and C2N Diagnostics, LLC, a specialist in advanced diagnostic solutions in the field of Alzheimer’s disease and related neurological disorders, have announced what the companies say is 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 revolutionising early diagnosis, and research efforts, and positively impacting long-term outcomes.”
Dr. Chaudhary continues: “C2N’s Precivity portfolio of blood tests and its innovative 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 personalised 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 maximise 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.
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 organisation that places a premium on quality in testing and in personalised diagnostics for Alzheimer’s disease.”
The PrecivityAD2 and PrecivityAD blood tests use highly sensitive and specialised 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.
