C2N Diagnostics, a prominent player in advanced brain health diagnostics, has announced the launch of its new PrecivityAD2 blood test. This clinical care assay has been developed to meet the standard of care set by existing PET scans and cerebrospinal fluid tests. The purpose of this blood test is to address the challenges faced by healthcare providers and patients in evaluating individuals displaying symptoms of Alzheimer’s disease (AD) and other cognitive decline causes.

The PrecivityAD2 test is a meticulously validated blood test that aids healthcare providers in either confirming or ruling out AD in patients exhibiting mild cognitive impairment or dementia symptoms. In a clinical validation study involving two distinct groups comprising a total of 583 patients with cognitive impairment, where amyloid PET was the reference standard, the PrecivityAD2 blood test demonstrated an overall test performance statistic of 0.94 AUC (Area Under the Curve) and an accuracy rate of 88%.

This innovative blood test concurrently measures specific plasma concentrations of amyloid beta and tau peptides, enabling the calculation of the Aβ42/40 Ratio and p-tau217/np-tau217 (p-tau217 Ratio). The utilization of plasma analyte ratios through proprietary mass spectrometry methods enhances the test's reliability and helps mitigate the impact of factors such as chronic kidney disease and cardiovascular disease. These ratios are integrated into a proprietary statistical algorithm that computes the Amyloid Probability Score 2 (APS2), a numerical value ranging from 0 to 100. The APS2 score determines whether a patient is likely Positive (with a high probability) or Negative (with a low probability) for the presence of brain amyloid plaques, as determined by an amyloid PET scan.

Furthermore, the credibility of the PrecivityAD2 blood test is reinforced by research from Dr. Sebastian Palmqvist and his team at Lund University in Sweden, which encompassed over 1,000 patients with cognitive concerns from various independent cohorts. The research, presented at the 2023 Alzheimer’s Association International Conference, indicated that the blood test exhibited a very high accuracy (AUC 0.95-0.97) in identifying Alzheimer's disease pathology, primarily utilizing cerebrospinal fluid biomarkers as the reference standard.

Dr. Demetrius Maraganore, a distinguished neurologist, highlighted the significance of the PrecivityAD2 blood test in diagnosing Alzheimer’s disease. He emphasized its convenience and accuracy as an alternative to PET scans and cerebrospinal fluid tests, which can be limited in availability. Dr. Maraganore expressed his intention to incorporate PrecivityAD2 into his practice to assess patients' eligibility for newly approved Alzheimer’s disease therapies.

This release further expands C2N's line of blood tests with the availability of the Precivity-ApoE test. Both tests are intended for patients aged 55 and older showing signs or symptoms of mild cognitive impairment or dementia who are undergoing Alzheimer’s disease or dementia evaluation. C2N's laboratory is certified, and the tests are available across various locations, with appointments for blood draws facilitated by a network of patient service centers and mobile phlebotomists.

Dr. Joel Braunstein, President and CEO of C2N, expressed his belief that the PrecivityAD2 blood test sets a new standard in Alzheimer's disease diagnosis. He highlighted its ability to address the need for an accurate, safe, non-invasive, and accessible alternative to amyloid PET scans and lumbar punctures. This announcement coincides with the approval of new disease-modifying therapies and emphasizes the convenience of having blood drawn for diagnosis at various sites or through mobile phlebotomists. C2N has received a Breakthrough Device Designation from the U.S. FDA, and the company is endorsed by numerous leading biopharmaceutical entities.

Source: businesswire.com

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