Simple Blood Test to Address Unmet Need in Alzheimer’s Disease Detection

AltPep Corporation (Seattle, WA, USA) has been granted Breakthrough Device designation by the US Food and Drug Administration (FDA) for its SOBA-AD diagnostic in development for AD. The inclusion in the FDA Breakthrough Devices Program means that AltPep can expect prioritized review of the submission of their device. The long-term potential for the SOBA-AD assay lies in its ability to detect disease early, even before symptoms arise. Early detection may lead to more effective treatments that limit cognitive decline in AD patients.

AD is the most prevalent form of dementia. A hallmark of AD is the aggregation of the amyloid-beta peptide. AltPep’s proprietary SOBA-AD assay, a simple blood test, detects toxic forms of this peptide at AD’s earlier stages. Current assessment technologies focus on symptoms or other markers that are only detectable once damage has occurred. Research has shown that early diagnosis of AD may enable access to treatments that could improve cognition and enhance quality of life. AltPep is also working to develop SOBIN treatments, potential disease-modifying therapies for amyloid diseases for treatment in concert with early detection. The company is developing early disease-modifying treatments and detection tools for amyloid diseases by targeting one of the earliest molecular triggers – toxic soluble oligomers. These oligomers are associated with many diseases, including neurodegenerative diseases and type 2 diabetes.

“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,” said Valerie Daggett, Ph.D., Founder and CEO of AltPep. “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.”

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