FDA gives breakthrough designation to assay for early Alzheimer’s

The FDA has given breakthrough device designation to the SOBA-AD assay, which may detect Alzheimer’s disease before symptoms arise, according to a press release.

Privately held biotech company AltPep Corp. announced the news about its assay, which detects toxic forms of amyloid-beta peptide in early AD, in a press release.

“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, PhD, founder and CEO of AltPep, said in the release. “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.”