The test measures phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology in patients 55 and older.
The US Food and Drug Administration (FDA) has cleared Roche’s Elecsys pTau181 test, a blood-based biomarker test indicated as an aid in the initial assessment for Alzheimer’s disease and other causes of cognitive decline in the primary-care setting.
The test is intended for patients ages 55 and older presenting with signs, symptoms or complaints of cognitive decline. It measures phosphorylated Tau (pTau) 181 protein in human plasma, a key biomarker for Alzheimer’s pathology, including amyloid plaque and tau aggregate pathology.
Developed in collaboration with Eli Lilly and Company, the minimally invasive test provides clinicians with information that can help identify patients in early stages of cognitive decline who are unlikely to have Alzheimer’s-related amyloid pathology. Results should be interpreted alongside other clinical information.
“By bringing Alzheimer’s blood-based biomarker testing into primary care, we can help patients and their clinicians get answers sooner to support them earlier in their journeys,” says Brad Moore, president and CEO of Roche Diagnostics North America, in a release.
Addressing Diagnostic Gaps
More than 7 million Americans are affected by Alzheimer’s disease, yet 92% of patients with mild cognitive impairment go undiagnosed and are unable to explore whether therapeutic intervention is possible, according to Roche.
Until now, Alzheimer’s biomarker testing has largely been limited to specialty settings such as neurology, according to a release from Roche. By enabling use in primary care, the Elecsys pTau181 test has the potential to broaden patient access to minimally invasive testing and help preserve specialist resources, notes the company release.
Primary care clinicians can better guide appropriate referrals so neurologists can focus on patients most likely to need advanced evaluation and treatment.
Clinical Performance and Infrastructure
The test’s performance was evaluated in a multicenter, non-interventional clinical study in 312 participants. Results demonstrated that in an early disease-stage, low-prevalence population reflective of primary care settings, Elecsys pTau181 could rule out Alzheimer’s pathology with a 97.9% negative predictive value.
The test is fully automated on Roche’s installed base of instruments.
In addition to FDA clearance in the US, Roche recently received CE Mark certification in Europe for the Elecsys pTau181 test.
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