15/10/2021

Quanterix Receives Label Growth on Crisis Use Authorization for COVID Antigen Check

BILLERICA, Mass.–(Business WIRE)–Quanterix Company (NASDAQ: QTRX), a company digitizing biomarker examination with the aim of advancing the science of precision wellness, announced that the Meals and Drug Administration (Fda) has expanded the Crisis Use Authorization (EUA) label for its Simoa® SARS-CoV-2 N Protein Antigen Test to incorporate tests with nasal swab and saliva samples, and for asymptomatic serial testing with nasal swab samples. The expanded label establishes this exam as the very first antigen check authorized for use with saliva samples. The examination is validated to detect all Variants of Problem now specified by the Centers for Condition Regulate (CDC) and is the initially non-NGS exam validated and independently confirmed to detect the really transmissible Delta variant (B.1.617.2) in sequence-verified medical samples. The check can be operate on Quanterix’ Simoa High definition-X Analyzer®, a entirely automated significant-throughput immunoassay instrument.

The Simoa SARS-CoV-2 N Protein Antigen Check detects the presence of the SARS-CoV-2 virus nucleocapsid protein (or N protein), which is acknowledged to be elevated in respiratory fluids in the course of the original acute phase of the an infection. The National Institutes of Health and fitness (NIH) Variant Process Drive has independently validated the assay’s capacity to detect all now selected Variants of Concern like the Delta variant in sequence-verified, medical nasal swab samples, including these with reduced viral load. Direct detection of antigen proteins from the virus may possibly be a much more meaningful evaluate of infection standing than detection of RNA by rRT-PCR because genetic product can linger even immediately after the virus has remaining the system, resulting in improved threat of bogus positives1.

The Delta variant is contributing to climbing circumstance counts throughout the world, and COVID-19 testing continues to be a precedence as faculties and workplaces endeavor to safeguard in opposition to the spread of the virus while normalizing their operations,” mentioned Kevin Hrusovsky, Chairman and Chief Executive Officer, Quanterix. “We are happy to get this EUA label growth on our antigen exam and exhibit another progress in the entire body of proof supporting Simoa’s potential for asymptomatic, a lot less-invasive scientific screening. While PCR testing stays the most important COVID-19 diagnostic modality, we imagine antigen screening with very simple sample collection in both equally symptomatic and asymptomatic people is a complementary for a longer period-term prospect to help regulate the distribute of COVID-19 and protect our most susceptible citizens.”

The expanded Food and drug administration authorization of the Simoa SARS-CoV-2 N Protein Antigen Take a look at is an vital following move in a job funded by the NIH Speedy Acceleration of Diagnostics (RADx) initiative to apply Simoa digital biomarker engineering to decentralized SARS-CoV-2 antigen detection in non-invasive sample kinds. The intention of this NIH system is to make improvements to scientific laboratory assessments that will improve the potential of SARS-CoV-2 tests in the U.S.

Simoa RUO assays for COVID-19 Exploration

Quanterix offers a family of assays personalized to Study Use Only (RUO) apps. In addition to its EUA assay, Quanterix has commercialized a SARS-CoV-2 N Protein Antigen Gain Assay. Quanterix has tailor-made this quantitative extremely-sensitive assay for research apps in sample matrices such as NP swabs, nasal swabs, serum, plasma, capillary dried blood, and saliva. The assay complements the Simoa SARS-CoV-2 IgG serology assay which represents an important software in ongoing vaccine advancement initiatives, specifically as the neighborhood seeks to understand serological signatures of protective immunity.

Kevin Hrusovsky commented: “The world wide exploration local community continues to invest in means to deepen the for a longer period-expression knowing of SARS-CoV-2 biology, including COVID-19 illness progression, innate and adaptive immune responses, and biomarkers indicative of disorder pathology, which includes a growing appreciation for the opportunity purpose of neurological markers. Our RUO portfolio of ultra-delicate assays involves a wide panel of markers joined to SARS-CoV-2 biology and disease progression and severity. Our engineering is enabling investigation on individuals with acute disorder, and these with prolonged-expression non-resolving signs (“COVID-19 extended haulers”), which includes individuals with neurological dysfunction. Blood-centered biomarkers show promise for predicting ailment severity and addressing this vital evolving investigation need.”

Simoa Technological know-how

Simoa (one molecule array technological innovation) is a innovative electronic tactic to immunoassays, which makes it possible for single molecules to be counted for protein biomarker investigation applications, changing the way researchers study the biology of wellness and illness by offering them the skill to carefully study critical biomarkers. In undertaking so, Quanterix permits improvement of approaches giving significantly previously ailment detection, better prognoses and increased remedy strategies to strengthen the top quality of life and longevity of the populace for generations to arrive. The engineering is now getting utilized for apps in a the vast majority of therapeutic places, which include oncology, neurology, cardiology, inflammation and infectious disorder.

For additional details on Quanterix’ Simoa technologies, go to https://www.quanterix.com/technological know-how. To find out additional about Quanterix’ infectious sickness exploration and RUO assay enhancement remedies, check out https://www.quanterix.com/therapeutic-regions/infectious-disease.

About Quanterix

Quanterix is a enterprise that is digitizing biomarker examination with the purpose of advancing the science of precision wellbeing. The company’s digital health and fitness option, Simoa®, has the prospective to transform the way in which health care is provided right now by giving researchers the potential to closely look at the continuum from health to sickness. Quanterix’ technological innovation is created to enable a great deal earlier disorder detection, much better prognoses and increased treatment techniques to strengthen the high quality of lifetime and longevity of the population for generations to arrive. The engineering is at this time being employed for analysis programs in many therapeutic regions, like oncology, neurology, cardiology, irritation and infectious condition. The business was established in 2007 and is found in Billerica, Massachusetts. For further data, be sure to go to https://www.quanterix.com.

Forward-Wanting Statements

This press launch contains forward-wanting statements inside of the this means of the Personal Securities Litigation Reform Act of 1995. Words this sort of as “could,” “will,” “anticipate,” “approach,” “foresee,” “estimate,” “intend” and very similar expressions (as perfectly as other words or expressions referencing potential gatherings, ailments or instances) are supposed to recognize forward-searching statements. Forward-hunting statements in this information release are based on Quanterix’ anticipations and assumptions as of the day of this push launch. Every single of these forward-on the lookout statements will involve hazards and uncertainties. Factors that may perhaps trigger Quanterix’ real final results to differ from individuals expressed or implied in the forward-hunting statements in this press release are talked over in Quanterix’ filings with the U.S. Securities and Exchange Commission, including the “Risk Elements” sections contained therein. Other than as needed by law, Quanterix assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new data gets to be out there.


1 https://www.medrxiv.org/written content/10.1101/2020.10.02.20205708v1