Amprion’s SYNTap Test for Alzheimer's Designated a Breakthrough Device

The FDA has designated San Francisco, Calif.-based Amprion’s SYNTap test for Alzheimer’s disease a breakthrough device.

In clinical studies, the test accurately predicted the presence of Lewy bodies, which are found in up to 40 percent of deceased Alzheimer's patients. Patients with this subtype of the disease tend to progress faster and need different treatments than others.

The test detects a misfolded protein called alpha-Synuclein, which combines with two other misfolded proteins, Abeta and Tau, to produce the Alzheimer's with Lewy bodies variant of the disease.