Quanterix Corporation (NASDAQ:QTRX) found its shares on the move Tuesday amid new developments concerning one of its processes.
The company announced its Simoa phospho-Tau 181 blood test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration as an aid in diagnostic evaluation of Alzheimer's Disease.
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. The program is designed to enable accelerated development, assessment and review processes, with the intention to provide patients with more timely access to breakthrough technologies or devices.
According to CEO Kevin Hrusovksy, "Quanterix’s technology has the unique ability to detect low-abundance markers in a blood sample, unlocking the possibility for earlier, more accessible, non-invasive diagnosis of disease, including AD. The breakthrough designation represents an important step in our long-term strategy to develop ultra-sensitive in vitro diagnostics.
"More importantly, it further validates the potential of our ultrasensitive Simoa technology, and we remain deeply committed to leveraging our innovative platform to support advances in neurodegenerative research and the translation of breakthrough scientific discoveries into the clinic. Our Research Use Only assays, including our Simoa pTau-181 assay, remain important tools in supporting these advances."
The Simoa pTau-181 test is a semi-quantitative immunoassay intended for the measurement of pTau-181 concentration in human serum and plasma using the Quanterix HD-X immunoassay system.
QTRX shares opened Tuesday higher by $5.71, or 13.8%, to $46.98.
