Quanterix gets Breakthrough Device designation by FDA for Simoa phospho-Tau 217

Quanterix announced that its Simoa phospho-Tau 217 blood test has been granted Breakthrough Device designation by the FDA as an aid in diagnostic evaluation of Alzheimer’s Disease, or AD. The FDA’s Breakthrough Device designation is granted to products that have the potential to offer more effective diagnosis of life-threatening diseases with an unmet medical need.