FDA clears new blood-based biomarker test that targets tau
Roche—a health technology company that specializes in medical research, pharmaceuticals and diagnostics—has received U.S. Food and Drug Administration clearance for a blood test that could alter how clinicians evaluate patients for Alzheimer’s disease.
The Switzerland-based company announced the clearance of the Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test on Monday. The product is cleared for use in adults ages 55 and older who show signs or express complaints of cognitive decline. The assay measures phosphorylated tau 217, a biomarker associated with amyloid pathology; it provides positive, intermediate or negative results indicating the likelihood that amyloid pathology is present—information that could be used to help providers determine the next steps in a patient’s management, including the need for PET imaging.
For imaging providers, the emergence of blood-based biomarker labs may represent a shift in how amyloid PET is utilized in specific populations. Though the exam remains an important tool for identifying the presence of amyloid, access to it can be limited by cost and availability. A blood-based test that can be performed through existing labs could allow clinicians to identify patients with a high or low likelihood of amyloid pathology before referring them for additional testing, saving patients time and money.
Dan Malarek, president and CEO of Roche Diagnostics North America, described the clearance as “an important milestone in Alzheimer’s disease diagnosis.”
"As the first and only FDA-cleared, single-biomarker blood test supporting both rule-in and rule-out assessment of amyloid pathology, Elecsys pTau217 has the potential to transform how Alzheimer's is assessed across primary and specialty care,” Malarek said in an announcement on the clearance. “This kind of innovation can help bring diagnostic evaluation closer to patients and give clinicians greater confidence in determining the right step in their care."
"While PET imaging and cerebrospinal fluid biomarkers can confirm amyloid pathology in patients with cognitive impairment, these approaches may be costly, invasive and not readily accessible for many patients," added Jared R. Brosch, MD, a neurologist with Indiana University Health. "Advances in blood-based biomarkers have the potential to transform the diagnostic pathway by expanding access to evaluation for Alzheimer's across a variety of care settings. As these tools become available, clinicians may be able to evaluate more patients earlier in the disease course, improving diagnostic confidence and helping patients and their families make more informed decisions at a critical time."
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.