Shares of Quanterix Corp. rose nearly 15% in early trading Tuesday after the company received U.S. Food and Drug Administration breakthrough-device designation for its Simoa phospho-Tau 181 blood test as an aid in diagnostic evaluation of Alzheimer's disease.
The Billerica, Mass., provider of digital health solutions said proposed indications under the designation include use of the test results in patients ages 50 and up presenting with cognitive impairment who are being evaluated for Alzheimer's and other causes of cognitive decline.
The FDA's breakthrough-devices program aims to expedite the development and review of technology that offers significant advantages over existing approved products.
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