11 January 2021 - - The Food and Drug Administration has issued an Emergency Use Authorization for US-based Quanterix Corp's (NASDAQ: QTRX) Simoa SARS-CoV-2 N Protein Antigen Test that can be run on the Simoa HD-X Analyzer, a fully automated high-throughput immunoassay instrument, the company said.

The Simoa SARS-CoV-2 N Protein Antigen Test detects the presence of the SARS-CoV-2 virus nucleocapsid protein (or N protein) which is known to be elevated in respiratory fluids during the initial acute phase of the infection.

Direct detection of antigen proteins from the virus may be a more meaningful measure of infection status than detection of RNA by rRT-PCR because genetic material can linger even after the virus has left the body, resulting in increased risk of false positives.

In clinical studies, the test demonstrated a sensitivity of 97.7% (positive percent agreement) and specificity of 100% (negative % agreement) up to 14 days following onset of symptoms.

Under the current EUA, the SARS-CoV-2 N Protein Antigen Test is intended for use with nasopharyngeal samples in individuals suspected of COVID-19 by their healthcare providers.

Quanterix will be pursuing authorization for additional sample types, including nasal swabs, saliva, and capillary dried blood obtained from a fingerstick.

Preliminary clinical research studies suggest the viral antigen may be readily detectable in asymptomatic and pre-symptomatic patients, and Quanterix is exploring extending the test to screening applications, home-based sample collection and pooling to enable larger scale testing.

FDA authorization of the Simoa SARS-CoV-2 N Protein Antigen Test for NP samples is an important early step in a project funded by the NIH Rapid Acceleration of Diagnostics initiative to apply Simoa digital biomarker technology to decentralized SARS-CoV-2 antigen detection in non-invasive sample types.

An ultimate aim of this NIH program is to improve clinical laboratory tests that will increase the capacity of SARS-CoV-2 testing in the US.

Quanterix offers a family of assays tailored to RUO applications. In addition to its EUA assay, Quanterix also announced the release of the SARS-CoV-2 N Protein Antigen Advantage Assay, tailored for Research Use.

This quantitative ultra-sensitive assay is directed to research applications in sample matrices including NP swabs, nasal swabs, serum, plasma, capillary dried blood, and saliva.

The assay complements the quantitative Simoa SARS-CoV-2 IgG antibody assay recently introduced for the HD-X instrument which enables researchers to measure both the virus and immune response from the same samples including blood obtained by minimally invasive fingerstick collection.

Simoa (single molecule array technology) is a revolutionary digital approach to immunoassays which allows single molecules to be counted for protein biomarker research applications, changing the way in which the biology of health and disease is studied by giving scientists the ability to closely examine critical biomarkers.

In doing so, Quanterix enables development of methods providing 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 applications in a majority of therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease.

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.

The company was established in 2007 and is located in Billerica, Massachusetts.