Quanterix Inc. (NASDAQ: (QTRX) stock plunged by 5.45% at last close whereas the QTRX stock price surges by 17.4% in the after-hours trading session. Quanterix is a start-up that digitizes biomarker analyses in order to advance precision health research.
QTRX stock’ Current Update
The United States Food and Drug Administration (FDA) has designated Quanterix Corporation’s Simoa phospho-Tau 181 (pTau-181) blood test as a Breakthrough Device to help in the diagnosis of Alzheimer’s disease (AD). Breakthrough Device designation is given by the FDA to devices that have the ability to improve the detection of life-threatening illnesses with unmet medical needs. The initiative is intended to speed up the development, assessment, and review procedures in order to provide patients with quicker access to breakthrough technology or equipment.
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The Simoa pTau-181 test is a semi-quantitative immunoassay that uses the Quanterix HD-X immunoassay equipment to assess pTau-181 levels in human blood and plasma. The use of test findings in older adults aged 50 and above who are being examined for Alzheimer’s disease or other reasons of cognitive decline as help in diagnostic assessment for AD is one of the suggested indications under the Breakthrough Device designation. The test is not meant to be used as a stand-alone diagnostic tool, and the findings will be used in conjunction with other diagnostic techniques to arrive at a final clinical diagnosis. The designation of a Breakthrough Device does not imply that the FDA regulatory approval process will be expedited or that an application will be granted.
Kevin Hrusovsky, Chairman and CEO, Quanterix Corporation commented,
Quanterix’s technology offers a distinctive potential to recognize low-abundance indicators in a blood sample, opening the door to earlier, more accessible, and non-invasive illness detection, including Alzheimer’s disease. The breakthrough status is a significant step forward in their long-term goal of developing ultra-sensitive in vitro diagnostics. More significantly, it confirms the promise of their ultrasensitive Simoa technology, and they remain dedicated to advancing neurodegeneration research and translating breakthrough scientific discoveries into the clinic using their cutting-edge platform.
