Research & Development
Quanterix awarded FDA's breakthrough device designation for Blood-Based pTau-181 Assay for Alzheimer's Disease
12 October 2021 -

Health company Quanterix Corporation (NASDAQ:QTRX) reported on Monday the receipt of the U.S. Food and Drug Administration's Breakthrough Device designation for Simoa phospho-Tau 181 blood test in the diagnostic aid and evaluation of Alzheimer's Disease (AD).

The company revealed the Simoa pTau-181 (pTau-181) test is a semiquantitative immunoassay intended for the measurement of pTau-181 concentration in human serum and plasma using its HD-X immunoassay system.

Under the US FDA's breakthrough device designation, the proposed indication include the use of the test results in adult patients aged 50 years and over as well as use the patient's AD cognitive impairment and other causes of cognitive decline in the diagnostic evaluation of AD.

In addition, the test results will be interpreted in conjunction with other diagnostic tools to establish a final clinical diagnosis. The FDA's breakthrough device designation 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, concluded the company.



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