A new blood test that could help identify Alzheimer’s earlier from healthcare company Roche has received a Breakthrough Device Designation from the U.S. Food and Drug Administration.
The test, branded “Elecsys” and under development with Eli Lilly and Company, can aid in identifying the likelihood of amyloid pathology in a person’s brain, according to Laura Parnas, disease area network lead of cardiometabolism for Roche Diagnostics North America. Elevated levels of the pTau217 protein found in human blood plasma occurs in early stages of Alzheimer’s.
“Blood-based tests for Alzheimer’s are highly appealing because they can be run inexpensively and at scale in large populations,” Parnas told Senior Housing News. “Roche, being the world’s leader in in-vitro diagnostics and with more than 100,000 instruments globally, could herewith guarantee worldwide access to timely Alzheimers’ diagnosis for patients.”
Following the designation from the FDA, Roche is in the process of making the test available for clinical use as soon as possible. The company pursued the designation “to demonstrate the benefit of pTau217 within the unmet medical need surrounding Alzheimer’s Disease,” Parnas said.
The designation will allow Roche to enhance partnerships with manufacturers, which Parnas said lets them interact with the FDA’s experts to receive feedback on device development, receive help from the FDA for marketing authorization and obtain prioritized review on regulatory submissions.
According to a press release, both Roche and Eli Lilly are hoping the collaboration will bring additional and scale to testing and diagnosis for the disease.
Parnas added blood testing will be a step forward in the field of neuropathology.
“Today, over 55 million people are living with dementia and this is projected to increase to nearly 140 million by 2050,” Parnas said. “The development of a blood based biomarker could play an important role in making timely and accurate diagnoses more accessible and to better monitor the effects of the rapidly developing disease modifying treatment for neurological diseases and dementia.”
