Quanterix submits FDA 510(k) for Alzheimer’s disease blood test

Quanterix (QTRX) announced it has submitted a 510(k) premarket notification to the FDA for a multi-analyte algorithmic blood test for Alzheimer’s disease detection. The test, which previously received Breakthrough Device Designation, is intended to aid in identifying patients with cognitive symptoms likely to have amyloid brain plaques. Quanterix stated the test utilizes its Simoa technology to measure a panel of five key analytes.