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Quanterix’s pTau-181 assay gets breakthrough device status

Quanterix has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its Simoa phospho-Tau 181 (pTau-181) blood test for the diagnostic evaluation of Alzheimer’s Disease (AD).

By using the Quanterix HD-X immunoassay system, the blood-based assay will measure the pTau-181 concentration in human serum and plasma.

The designation allows to use the test for adult patients aged 50 years and above with cognitive impairment who are being assessed for AD, as well as other causes of cognitive decline as an aid in diagnostic evaluation for AD.

According to the company, the test is not intended as a stand-alone diagnostic assay and test results will be interpreted along with other diagnostic tools to establish a final clinical diagnosis.

Quanterix chairman and CEO Kevin Hrusovsky said: “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.”

In January this year, the company secured an emergency use authorisation from the FDA for its Simoa SARS-CoV-2 N protein antigen test.

The US agency has expanded the EUA label for its Simoa SARS-CoV-2 N protein antigen test in September this year.

The expanded label includes testing with nasal swab and saliva samples, and for asymptomatic serial testing with nasal swab samples. NS Medical Devices

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