Roche's Alzheimer's blood test earns breakthrough label from FDA

In the wake of the FDA handing down its first clearance for an in vitro test for early-stage Alzheimer’s disease in May, the floodgates have been opened.

Among the next diagnostics on the agency’s docket is one developed by Roche that’s geared toward helping determine whether an individual’s cognitive decline is more likely linked to Alzheimer’s or to another cause.

The blood-based biomarker test has already garnered the FDA’s breakthrough device designation, Roche announced Tuesday. That label will speed up the test’s route through the review process on its way to a full-blown clearance.

The Elecsys Amyloid Plasma Panel measures the amount of phosphorylated tau 181 and apolipoprotein e4 in an individual’s blood sample, also known as pTau-181 and ApoE4, respectively. Elevated levels of pTau have been shown to correlate with the onset of Alzheimer’s, while the presence of the ApoE4 gene is believed to be among the strongest risk factors for the disease—though not all carriers of the gene go on to develop Alzheimer’s.

The test isn’t meant to be used as a standalone diagnostic for the disease, but rather as part of an overall assessment that also takes into account a patient’s clinical information and the results of additional testing.

By quantifying those two biomarkers, Roche’s diagnostic can pinpoint which individuals should undergo confirmatory testing for Alzheimer’s via amyloid PET scans or cerebrospinal fluid assessment. Meanwhile, those who test negative with the panel can be directed toward follow-up testing for other potential causes of cognitive decline.

That way, the panel may not only speed up the diagnostic process for people with Alzheimer’s but also prevent those who likely don’t have it from undergoing more invasive and expensive testing for the disease.

“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,” said Thomas Schinecker, Ph.D., CEO of Roche Diagnostics. “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.”

The FDA’s breakthrough-device designation comes not long after the regulator awarded its first clearance to an in vitro diagnostic for the disease. The Lumipulse test from Fujirebio Diagnostics examines a sample of cerebrospinal fluid to measure the ratio of two specific beta-amyloid proteins in the brain; results of the test have been shown to align with those of PET brain scans.

Like Roche’s offering, the diagnostic is meant to be used in tandem with other clinical evaluations, especially since positive results from the Lumipulse test don’t definitively indicate the presence of Alzheimer’s and may even come from cognitively healthy people.