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