Blood Biomarker Test Designated a Breakthrough Device

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by Lindsey Shapiro, PhD |

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The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Elecsys Amyloid Plasma Panel, Roche’s blood-based biomarker test designed to enable earlier Alzheimer’s disease diagnoses.

Breakthrough device designation is granted to medical devices that provide a more effective way of treating or diagnosing a life-threatening or irreversibly debilitating disease. The status is meant to speed the device’s development toward regulatory approval.

“The key to transforming the life of people with Alzheimer’s disease is to diagnose as early as possible and intervene with the right care plans,” Thomas Schinecker, CEO of Roche Diagnostics, said in a press release.

“Our new diagnostics test has the potential to streamline a patient’s journey, improving speed and access toward a confirmatory diagnosis, giving people with Alzheimer’s disease and their caregivers more time to plan and prepare for the future,” Schinecker added.

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The diagnosis of Alzheimer’s disease is typically based on clinical symptoms, including cognitive assessments, but a significant proportion of individuals with Alzheimer’s are not diagnosed until the disease has advanced significantly. On average, patients wait 2.8 years to receive their diagnosis, Roche noted, with many other patients still awaiting a diagnosis.

The Elecsys assay, which measures levels of Alzheimer’s disease biomarkers in blood samples, is intended to be used in combination with other clinical information to indicate when there is a need for more confirmatory testing for the neurodegenerative disease in symptomatic patients.

The panel combines two different protein assays. The first biomarker is phosphorylated tau (pTau) 181, a protein that is elevated in the early stages of Alzheimer’s disease, which has been proposed as an early predictor of cognitive decline in Alzheimer’s patients.

The assay also will measure the apolipoprotein E4 (APOE4) protein in a person’s blood. APOE4 is an apolipoprotein subtype that constitutes the most common genetic risk factor for Alzheimer’s.

Patients who test negative, that is, do not have detectable pTau181 or APOE4 levels, and are not likely to have signs of amyloid buildup in the brain — the hallmark of Alzheimer’s. These patients should be assessed for other causes of cognitive decline, according to Roche.

Follow up with PET scan

For those who do test positive, patients should undergo further confirmatory testing such as positron emission tomography (PET) scans to evaluate amyloid buildup or testing of the cerebrospinal fluid (CSF, the fluid that surrounds the brain and spinal cord).

According to the company, this test, in combination with the work the company is doing toward developing potential new Alzheimer’s treatments, could help improve the care and outcomes for people with the disease.

Two of Roche’s other CSF-based diagnostic tests also have received breakthrough device designation. The Elecsys beta-amyloid (1-42) test measures levels of beta-amyloid while the Elecsys Phospho-Tau (181P) test measures levels of pTau181. These tests are designed for adult patients with cognitive impairment who are being evaluated for Alzheimer’s or other causes of dementia.

According to the company, Roche now is the first in-vitro diagnostics manufacturer to receive this designation for a blood-based biomarker test for Alzheimer’s.