FDA grants breakthrough designation for Lewy body detection test

The FDA granted breakthrough device designation to Amprion for its SYNTap Test, which detects a distinct protein as an indicator of Alzheimer’s disease with Lewy bodies, according to a news release.

“This insight elevates our understanding of Alzheimer's as medical science strives to find cures for neurodegenerative diseases,” Claudio Soto, PhD, Amprion co-founder and chief scientific officer, said in the release. “Since AD with Lewy Bodies requires different treatments, it is critical to distinguish it early.”

The SYNTap Test detects misfolded alpha-Synuclein to aid with early detection of AD with Lewy bodies, which tends to cause faster disease progression than classic AD. In addition, patients can often present overlapping symptoms of Lewy body dementia and Parkinson's disease, making early detection key.

In a joint study with Oregon Health & Science University, Amprion conducted blinded analysis using cerebrospinal fluid samples from patients diagnosed with AD and other non-synucleinopathy neurodegenerative diseases, as well as from healthy patients. Samples were collected 1 to 15 years prior to autopsy.

During clinical test development, the SYNTap Test was able to accurately predict presence of Lewy bodies, which were later confirmed during autopsy. Similar results were demonstrated through a confirmatory study performed at the University of California, San Diego using CSF collected before autopsy, as well as after death. In that study, none of the CSF samples from 36 patients who showed no brain Lewy bodies at autopsy tested positive for the protein.

During Amprion’s clinical validation study, the SYNTap Test detected the presence of misfolded alpha-Synuclein aggregates with a sensitivity of 87.3% and a specificity of 97.2%.