Celltrion to Launch Both Antigen and Antibody Testing Kits in the U.S.
Celltrion Group (KRX:068270) today announced the launch of two rapid kits for SARS-CoV-2 in the US by the third week of August.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200811005863/en/
SAMPINUTE™ COVID-19 Antigen MIA (left) and DiaTrust™ COVID-19 IgG/IgM Rapid Test (Photo: Business Wire)
SAMPINUTETM COVID-19 Antigen MIA is an electrochemical immunoassay test for detection of SARS-CoV-2 antigen from nasopharyngeal swab samples, composed of one time use test cartridges and a portable analyzer developed in collaboration with BBB1.
DiaTrustTM COVID-19 IgG/IgM Rapid Test is a one-step in-vitro diagnostic test based on immunochromatographic assay designed for the rapid detection of antibodies of the novel coronavirus in healthcare settings in collaboration with Humasis2.
Both SAMPINUTETM COVID-19 Antigen MIA (antigen test) and DiaTrustTM COVID-19 IgG/IgM Rapid Test (antibody test) have shown reliable performance and promising clinical trial results. SAMPINUTETM COVID-19 Antigen MIA has a sensitivity of 94% and a specificity of 100%, with time to results within 10 minutes.
DiaTrustTM COVID-19 IgG/IgM Rapid Test also shows reliable performance with 96% positive percent agreement and 98.67% negative percent agreement for IgM, 92% positive percent agreement and 100% negative percent agreement for IgG. The turnaround time is 15 minutes.
Celltrion requested Emergency Use Authorization (EUA) for SAMPINUTETM COVID-19 Antigen MIA on July 24th, and for DiaTrustTM COVID-19 IgG/IgM Rapid Test on July 8th. The rapid tests kits are currently under the review of the US Food and Drug Administration’s Emergency Use Authorization. Celltrion anticipates the FDA EUA approval and subsequent commercialization in the US market by mid-August.
Celltrion is also developing a potential antiviral treatment for COVID-19 with its phase I clinical study initiated on July 17th.
Celltrion plans to launch the second generation antibody and antigen tests, in collaboration with the DiaTrustTM COVID-19 IgG/IgM Rapid Test’s manufacturer Humasis, for which Celltrion will apply its proprietary COVID-19 antibody-antiviral technology to enhance detection sensitivity during the second half of 2020.
“Celltrion has been striving to bring the tests into the US. The need for more accessible, affordable, and most importantly, rapid diagnostic testing will grow, as the daily activities are coming back, and the economy is opening up again,” a Celltrion representative stated. “With the short turnaround time and promising performance of the sensitivity and specificity results, Celltrion is confident that both SAMPINUTETM COVID-19 Antigen MIA and DiaTrustTM COVID-19 IgG/IgM Rapid Test will add great value to healthcare providers in screening patients and keeping communities safe.”
About Celltrion, Inc
Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in the research, development and manufacture of small molecules, biosimilars and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EC’s approval for INFLECTRA® and Remsima®, respectively, the world’s first mAb biosimilar approved from regulatory agencies in developed countries. For more information, visit www.celltrion.com.
FORWARD LOOKING STATEMENT
Certain information set forth in this press release contains statements related to our future business and financial performance, and future events or developments involving Celltrion/Celltrion USA, Inc. that may constitute forward-looking statements under pertinent securities laws.
These statements may be identified by words such as “prepares,” “hopes to,”“upcoming,” ”plans to,” “aims to,” “to be launched,” “is preparing,” “once gained,” “could,” “with the aim of,” “may,”“once identified,” “will,” “working towards,” “is due,” “become available,”“has potential to,” the negative of these words or such other variations thereon or comparable terminology.
In addition, our representatives may make forward-looking oral statements. Such statements are based on the current expectations and certain assumptions of Celltrion/Celltrion USA, Inc.'s management, of which many are beyond its control.
Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance, and undue reliance should not be placed on them.
Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.
Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion USA, Inc. believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion USA, Inc. undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
1 For more information, visit https://www.bbbtech.com/
2 For more information, visit http://humasis.com/
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Bentley Systems Announces Pricing of Initial Public Offering23.9.2020 02:45:00 CEST | Press release
Bentley Systems, Incorporated (“Bentley”) today announced the pricing of the initial public offering of 10,750,000 shares of its Class B common stock at a price to the public of $22.00 per share. The shares of Class B common stock to be sold in the offering are being sold by existing stockholders of Bentley. The selling stockholders granted the underwriters in the offering a 30-day option to purchase up to an additional 1,610,991 shares of Class B common stock from the selling stockholders. The shares are expected to begin trading on the Nasdaq Global Select Market on September 23, 2020 under the symbol “BSY”. The offering is expected to close on September 25, 2020, subject to customary closing conditions. Goldman Sachs & Co. LLC and BofA Securities are acting as lead book-running managers and RBC Capital Markets is acting as a book-running manager for the offering. Baird, KeyBanc Capital Markets and Mizuho Securities are acting as co-managers for the offering. A registration statement
SES Becomes Microsoft Azure Orbital Founding Connectivity Partner22.9.2020 21:00:00 CEST | Press release
SES today announced it has joined as the medium Earth orbit (MEO) connectivity partner for Microsoft Azure Orbital, Microsoft’s new managed service enabling network operators to communicate and control their satellite capacity, process data, and scale their operations directly within Azure. The integration is part of a multi-year agreement between the two companies that accelerates and expands SES’s use of Azure to significantly advance the digital transformation of the company’s services and operations as part of its cloud-first strategy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200922005927/en/ SES Becomes Microsoft Azure Orbital Founding Connectivity Partner (Photo: Business Wire) As pioneers in Microsoft’s new cloud ecosystem in space, the two companies will make joint investments in Azure Orbital ground stations that SES will deploy and manage for the MEO and Earth Observation segments. The first MEO and Earth Obs
SES Advances Digital Transformation with Cloud-First Strategy, Expanded Agreement22.9.2020 21:00:00 CEST | Press release
SES today announced plans to significantly advance its digital transformation across its enterprise, operations and development of new services for the cloud-scale era. As a cornerstone of the strategy, SES signed a multi-year agreement with Microsoft to be an Azure Orbital partner as well as to accelerate and expand the use of Microsoft Azure across its operations and jointly develop cloud-based video and data connectivity managed services. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200922005930/en/ SES Advances Digital Transformation with Cloud-First Strategy, Expanded Agreement (Photo: Business Wire) As an Azure Orbital partner, SES will be co-locating and managing O3b mPOWER gateways with Microsoft Azure locations so its customers are always only “one-hop” away from their Azure cloud services anywhere in the world. In addition, SES customers will enjoy improved network performance, speed-to-market, flexibility and sc
Workiva Wraps Up Amplify 2020: Global Conference Transformed into a Virtual Experience for Over 6,000 Attendees Across 60 Countries22.9.2020 18:13:00 CEST | Press release
Workiva Inc. (NYSE:WK), the company that simplifies complex work, wrapped up its largest annual conference, Workiva Amplify, following three days of incredible virtual experiences. More than 6,000 attendees from over 60 countries participated in 42 customer, partner and Workiva led sessions focused on solving the universal challenges of data, process and reporting complexity. “This year’s record attendance at Amplify underscores the importance that organizations have placed on utilizing cloud platforms to enable greater transparency, instill trust and streamline processes,” said Workiva CEO Marty Vanderploeg. “We are proud that Amplify continues to be a place where our customers can access innovative technology and insights that help them confidently move their organizations forward.” Workiva Amplify 2020 Highlights include: Trust in an Age of Transformation The Amplify general session featured Workiva leadership and customers who highlighted the need for stability and experience when
OCP Announces Date of Second Quarter and First Half 2020 Earnings22.9.2020 18:10:00 CEST | Press release
OCP S.A. (“OCP” or the “Company”), a global leader in the fertilizer industry, will release its second quarter and first half 2020 results on Tuesday, September 29, 2020. The results will be available to holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers on the OCP Intralinks portal from 9:00 a.m. EDT, 2:00 p.m. Morocco and London time (GMT+1). OCP senior management will host a conference call to discuss second quarter and first half 2020 results at 10:00 a.m. EDT, 3:00 p.m. Morocco and London time (GMT+1) on Tuesday, September 29, 2020 for holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers. Eligible parties that have not already registered for access to the Intralinks portal may do so by contacting the Investor Relations Department by emailing email@example.com. About OCP OCP is a global leader in the fertilizer industry, backed by almost a century’s production history. OCP has exc
Movius WhatsApp Integration Creates First True Compliant Mobile Unified Communications Solution22.9.2020 17:00:00 CEST | Press release
Movius, the leading global provider of mobile unified communication software, is now enabling enterprises to securely and compliantly communicate with clients on their preferred mobile messaging channel. Today, the company announced the integration of WhatsApp support from within Movius MultiLine, their secure mobile communication service that can be deployed over any smartphone device on any global carrier. The integration will help unify and capture all business voice and messaging channels through a single integrated user experience, while enabling firms to effortlessly meet regulatory and surveillance needs. An open Beta for this integration is available now and general availability is expected in the fourth quarter, 2020. As users continue to work remotely, they will find the expanded enterprise service provides unmatched productivity anywhere – and compliance everywhere – especially as companies accelerate their emerging Bring Your Own Device (BYOD) strategies and implementations