Lilly, Roche to get expedited FDA review for Alzheimer’s diagnostic test
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A new blood test being developed through a collaboration between Roche Diagnostics and Eli Lilly and Co. has been granted a breakthrough device designation by the U.S. Food and Drug Administration.
The designation is intended to speed development and expedite review by federal regulators, especially for critical diseases.
The plasma biomarker test is designed to help physicians identify amyloid pathology, a key feature of Alzheimer’s disease. Roche and Lilly said they believe the test could play an important role in improving access to early and accurate Alzheimer’s diagnosis.
There are currently no FDA authorized blood tests for Alzheimer’s, a disease that afflicts more than 50 million people worldwide, robbing patients of memories and cognitive abilities.
Today, the only FDA-cleared methods to confirm amyloid pathology are cerebrospinal tests and amyloid positron emission tomography scan imaging.
Today, the only FDA-cleared methods to confirm amyloid pathology of cerebrospinal test and amyloid positron emission tomography scan imaging.
What Roche and Lilly are developing is a diagnostic immunoassay called elecsys phosphor-tau217 to detect proteins associated with Alzheimer’s disease in people 60 and older. The two companies announced the FDA action Thursday.
“The incidence of dementia is growing worldwide, with 75% of cases remaining undiagnosed,” Matt Sause, CEO of Roche Diagnostics, said in written remarks. “Consequently, there is a role for (Roche) Diagnostics to play in addressing this global health challenge.
Ann White, president of Lilly Neuroscience, called Elecsys pTau217 plasma assay “another milestone in our collaboration with Roche Diagnostics that will advance the Alzheimer’s diagnostic ecosystem.
pTau217, which is a phosphorylated fragment of the protein tau, is a biomarker that has shown the ability in research settings to distinguish Alzheimer’s disease from other neurodegenerative disorders, the companies said.
Roche Diagnostics’ U.S. headquarters is based on a huge campus on the northeast side of Indianapolis. The operation is a unit of Swiss-based pharmaceutical giant Roche AG.
Lilly’s headquarters and research laboratories are based on two large campuses just south of downtown.
Roche has also developed an experimental Alzheimer’s disease drug called trontinemab that has been shown in a small trial to clear clumps of amyloid protein from the brains of patients.
Lilly is awaiting approval from the FDA for an experimental drug called donanemab that the company says can modestly slow progression of the disease in Alzheimer’s patients by four to seven months.