C2N Diagnostics has introduced a new assay called the PrecivityAD2 blood test for clinical care.
Healthcare providers can use the new blood test to assess patients with signs and symptoms of Alzheimer’s disease (AD) and other causes of cognitive decline.
The analytically and clinically validated test allows them to determine whether a patient with mild cognitive impairment or dementia has Alzheimer’s disease or not.
For calculating the Aβ42/40 Ratio and p-tau217/np-tau217 (p-tau217 Ratio), the test simultaneously quantifies specific plasma amyloid beta and tau peptide concentrations.
The test attained an overall performance statistic of 0.94 AUC and 88% accuracy in a clinical validation study that involved two independent cohorts.
It involved 583 patients with cognitive impairment using amyloid PET as the reference standard.
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Furthermore, the validity of the PrecivityAD2 blood test is reinforced by research conducted by Dr Sebastian Palmqvist and his team at Sweden’s Lund University.
Their investigations, encompassing the BioFINDER-Primary Care and Memory Care studies, encompassed more than 1,000 patients with cognitive concerns across four independent cohorts.
C2N president and CEO Dr Joel Braunstein said: “The 2022 Clinical Trials on Alzheimer’s Disease Task Force report outlined that combined biomarkers can be especially helpful in avoiding misdiagnosis and PrecivityAD2 does just that by harnessing two established biomarkers in one assay.
“We believe the test addresses a major unmet need for an accurate, safe, non-invasive and accessible alternative to amyloid PET scans and lumbar punctures.”
PrecivityAD2 complements the company’s Precivity-ApoE blood test, which is designed for adult patients and provides significant information about apolipoprotein E2, E3 and E4 allele status to guide medical management and treatment decisions.