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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowRoche Diagnostics says it has developed blood tests to help rule out a diagnosis of Alzheimer’s disease in the broad population, thus narrowing who might be suffering from the disease.
Nearly 7 million Americans live with Alzheimer’s disease, one of the most challenging diseases to diagnose and treat because early symptoms can be subtle and remain hidden until the condition has progressed.
But the Indianapolis-based diagnostics company recently presented data at an Alzheimer’s conference in Madrid, Spain, that could give clinicians the ability to rule out Alzheimer’s disease as a possible cause of cognitive symptoms with a simple blood test.
That blood test can show whether the patient has amyloid pathology—or sticky buildup in the brain that is a hallmark of Alzheimer’s disease.
“We are able to rule out the presence of amyloid pathology in pretty much a real-world population,” Laura Parnas, senior leader of medical and scientific affairs for Roche Diagnostics, told IBJ. “Our clinical trial was designed to basically look at how patients are presenting and how accurate our tests are in ruling out the presence of amyloid pathology.”
According to Roche, a positive result would show a high likelihood of finding evidence of Alzheimer’s disease characteristic through a PET scan or a cerebrospinal fluid test.
Roche is developing the tests in partnership with Indianapolis-based Eli Lilly and Co. Earlier this year, the U.S. Food and Drug Administration granted a breakthrough device designation to the product, formally called an Elecsys pTau217 assay. It’s a simple blood test that can be used to help identify the presence of amyloid pathology in patients.
If approved, the test can help rapidly broaden access to a more timely and accurate diagnosis, Roche said.
“We are excited to be collaborating with Lilly on such an important area of unmet medical need,” said Matt Sause, CEO of Roche Diagnostics, in written remarks.
Roche said the goal is to detect the disease early and stop its progression to preserve what makes people who they are.
“We are pleased to be joining Roche to support the development of yet another potential diagnostic tool,” said Mark Mintun, Lilly group vice president of Neuroscience R&D, in written remarks last year.
At the Madrid conference, Roche’s diagnostics unit showed that a negative result from one test—its Elecsys amyloid plasma panel, which checks blood levels for a combination of phosphorylated Tau-181 and apolipoprotein E4—could be counted on to help identify patients who were unlikely to have the amyloid plaque deposits associated with Alzheimer’s, according to Fierce Biotech, an industry news site.
In clinical practice, this comparatively simple blood test could help health care providers decide whether or not to pursue further exams with PET brain scans or drawing cerebrospinal fluid samples, it added
The clinical trial enrolled 492 patients and showed the amyloid panel’s negative predictive value of 96.2%, according to Roche.
“The data from this large-scale study in cognitively impaired individuals suggests that a fast and simple blood test could reliably rule out amyloid pathology, offering much-needed reassurance to patients and their families,” Roche’s Sause said in a statement.
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