Therapy Areas: Oncology
Quanterix Granted Breakthrough Device Designation from US FDA for Blood-Based pTau-181 Assay for Alzheimer's Disease
12 October 2021 - - US-based digital health solutions company Quanterix Corp's (NASDAQ: QTRX) Simoa phospho-Tau 181 (pTau-181) blood test has been granted Breakthrough Device designation by the US Food and Drug Administration as an aid in diagnostic evaluation of Alzheimer's Disease, the company said.

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.

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

Proposed indications under the Breakthrough Device designation include use of the test results in adult patients, aged 50 years and over, presenting with cognitive impairment who are being evaluated for AD and other causes of cognitive decline as an aid in diagnostic evaluation for AD.

The test is not intended as a stand-alone diagnostic assay and test results will be interpreted in conjunction with other diagnostic tools to establish a final clinical diagnosis.

Breakthrough Device designation does not guarantee that the FDA review and approval process will be shortened or that an application will be approved.

Quanterix is a company that's digitizing biomarker analysis with the goal of advancing the science of precision health.

The company's digital health solution, Simoa, has the potential to change the way in which healthcare is provided by giving researchers the ability to closely examine the continuum from health to disease.

Quanterix' technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come.

The technology is currently being used for research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease. The company was established in 2007 and is located in Billerica, Massachusetts.