Sam Brusco, Associate Editor03.01.22
AltPep Corp., a company developing early amyloid disease-modifying treatments and detection tools, gained U.S. Food and Drug Administration (FDA) breakthrough status for its SOBA-AD diagnostic that is currently in development for Alzheimer’s disease.
The SOBA-AD assay’s long-term potential lies in its ability to spot disease early, possibly before symptoms arise. Early detection can lead to more effective treatments to limit cognitive decline from Alzheimer’s.
“Receiving FDA Breakthrough Device designation is an extremely important recognition that will support our efforts to help fill an unmet medical need and bring the SOBA-AD test initially to aid in the diagnosis of AD in patients that present mild cognitive impairment in memory-care and clinical settings,” Valerie Daggett, Ph.D., founder and CEO of AltPep told the press. “Existing FDA-cleared diagnostic tests for AD reflect amyloid-beta plaques and neurofibrillary tangles in the brains of patients; the SOBA-AD test in plasma aims to detect the early molecular triggers of the disease, before plaque formation.”
Alzheimer’s is the most common form of dementia, with an estimated six million Americans living with the disease.
The SOBA-AD assay’s long-term potential lies in its ability to spot disease early, possibly before symptoms arise. Early detection can lead to more effective treatments to limit cognitive decline from Alzheimer’s.
“Receiving FDA Breakthrough Device designation is an extremely important recognition that will support our efforts to help fill an unmet medical need and bring the SOBA-AD test initially to aid in the diagnosis of AD in patients that present mild cognitive impairment in memory-care and clinical settings,” Valerie Daggett, Ph.D., founder and CEO of AltPep told the press. “Existing FDA-cleared diagnostic tests for AD reflect amyloid-beta plaques and neurofibrillary tangles in the brains of patients; the SOBA-AD test in plasma aims to detect the early molecular triggers of the disease, before plaque formation.”
Alzheimer’s is the most common form of dementia, with an estimated six million Americans living with the disease.