C2N Diagnostics’ PrecivityAD2 is the first blood-based diagnostic cleared for younger symptomatic patients experiencing cognitive impairment.
The Food and Drug Administration (FDA) cleared C2N Diagnostics’ PrecivityAD2 blood test for use in adults as young as 40 who are experiencing signs of cognitive impairment. This clearance makes it the first FDA-cleared Alzheimer’s blood test available to patients in this age group, according to an announcement from the Alzheimer’s Drug Discovery Foundation.
The decision reflects the increasing use of blood-based diagnostics to provide earlier and more accurate detection in clinical care. The field has long recognized that Alzheimer’s pathology can begin 15 to 20 years before symptoms appear, and validated tools for patients in their 40s and 50s are intended to pave the way for earlier treatment.
“Today’s clearance reflects how rapidly the field is advancing. Just over a year ago, there were no FDA-cleared blood tests for Alzheimer’s, and now we have three,” says Isobel Coleman, CEO of the Alzheimer’s Drug Discovery Foundation, in a release.
Indication and Clinical Performance
The test is indicated for adults aged 40 years and older who present with signs or symptoms of cognitive impairment. It is intended to help clinicians identify patients with amyloid pathology but is not meant to be used as a screening tool or a stand-alone diagnostic test, the company says.
In a clinical validation study involving 1,142 subjects with cognitive decline, the test demonstrated a 97.6% positive predictive value for ruling in Alzheimer’s and a 93.1% negative predictive value for ruling it out. These results were based on comparisons to established reference methods, including amyloid positron emission tomography scans and cerebrospinal fluid biomarker testing. Performance remained consistent across 12 chronic diseases commonly associated with aging, such as diabetes, chronic kidney disease, and high blood pressure, according to C2N Diagnostics (similar reliability has also been demonstrated in other patient groups, such as those using Alzheimer’s blood tests for Down syndrome).
Mass Spectrometry Technology
The PrecivityAD2 test utilizes high-resolution mass spectrometry to quantify protein biomarkers in the blood. The technology simultaneously measures amyloid and tau peptide isoforms, specifically the Aβ42/40 and p-tau217/np-tau217 ratios. These ratios are then combined into a proprietary algorithm to calculate an amyloid probability score 2, which indicates the likelihood of amyloid pathology, the company says.
The FDA-cleared version of the test is expected to be available later this year. Currently, a version validated under the Clinical Laboratory Improvement Amendments remains available through the C2N clinical laboratory.
The company notes that early diagnosis is critical, as an estimated 19-20 million US adults aged 65 and older, along with hundreds of thousands between ages 45 and 65, are living with cognitive impairment. Braunstein says the test will help “streamline and simplify the complex diagnostic pathway that many patients face when dealing with serious memory concerns,” in a release.
“The FDA clearance is a watershed moment for our company, the entire Alzheimer’s disease community, the field of molecular diagnostics, and precision medicine,” says Joel Braunstein, MD, C2N co-founder, CEO, and president, in a release.
Laura Nisenbaum, interim chief science officer at the Alzheimer’s Drug Discovery Foundation, add in a release, “PrecivityAD2 reflects how far biomarker science has come, and it points to an even bigger opportunity ahead. Tests like this don’t just help to diagnose Alzheimer’s; they can also identify the right patients for a clinical trial and confirm whether a drug is engaging its target.”
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