
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/
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200811005863/en/
Contact information
Celltrion, Inc.
Eunyoung Lee, +82 32 850 4384
Eunyoung.lee1@celltrion.com
Or
Tae-Gyun Kim, +82 32 850 5136
Taegyun.kim@celltrion.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
H.I.G. Capital Announces the Sale of DGS S.p.A.11.6.2024 12:00:00 CEST | Press release
H.I.G. Capital (“H.I.G.”), a leading global alternative investment firm with $62 billion of capital under management, is pleased to announce that an affiliate has signed a definitive agreement to sell its portfolio company, DGS S.p.A. (“DGS” or the “Group”), a leading firm in the Italian Information Technology market, to DGS Co-Founders and management team in partnership with ICG, a global alternative asset manager. Since its inception in 1997, DGShas supported blue-chip customers in the design, integration, and maintenance of complex IT systems, with a specialization in digital transformation and cybersecurity services. The Group currently has over 1,900 employees, revenues of approximately €300 million, and maintains a group of highly loyal clientele. During H.I.G.’s ownership, DGS has tripled in size and consolidated its position as a leading Italian firm in cybersecurity services and digital transformation. DGS offers its clients sophisticated and proprietary digital transformation
Evertas Names Nick Selby Head of European Underwriting11.6.2024 12:00:00 CEST | Press release
Evertas, the world’s first crypto insurance company, has named Nick Selby as its new Head of European Underwriting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240611141887/en/ Nick Selby, Executive Vice President and Head of European Underwriting at Evertas (Photo: Business Wire) Selby, an accomplished information and physical security professional, brings two decades of expertise in public and private sector information security, physical security, and complex incident handling, as well as seven years of experience leading teams securing billions of dollars in cryptoassets. Previously, his roles included VP of the Software Assurance Practice at Trail of Bits, Chief Security Officer at Paxos Trust Company, and Director of Cyber Intelligence and Investigations at the NYPD Intelligence Bureau. “Nick is an extremely valuable addition to our European team,” said Evertas CEO and Co-Founder J. Gdanski. “His public and private
Owlet utvider globalt fotavtrykk med lanseringen av medisinsk-sertifisert Dream Sock™ i Storbritannia og over hele Europa11.6.2024 11:00:00 CEST | Pressemelding
Owlet, Inc. («Owlet» or the «Company») (NYSE:OWLT), pioneren innen smart spedbarnsovervåking, kunngjør i dag den britiske og europeiske lanseringen av Dream Sock. Dette er en smart babymonitor med levende helseavlesninger og varsler for friske spedbarn mellom 0-18 måneder og 2,5-13,6 kg. Dette innovative medisinske utstyret gir foreldre helse og viktig informasjon i sanntid, noe som gir uovertruffen trygghet. Denne pressemeldingen inneholder multimedia. Se hele pressemeldingen her: https://www.businesswire.com/news/home/20240611820341/no/ (Photo: Business Wire) «Vi er svært stolte over å lansere Dream Sock til omsorgspersoner over hele Storbritannia og Europa og gi millioner av foreldre mer trygghet mens babyen sover,» sa Kurt Workman, Owlets administrerende direktør og medgründer. «Dream Sock er nå et globalt produkt som er anerkjent som medisinsk nøyaktig og trygt, etter å ha gjennomgått regulatoriske autorisasjoner og sertifiseringer innenfor flere geografier. I dag er misjonen vår
V-Nova Surpasses 1000 Patent Milestone in Media Technology Innovation11.6.2024 10:00:00 CEST | Press release
V-Nova, a leading provider of data compression solutions, video compression technology, XR technology, AI acceleration and parallel processing for a multitude of industries including media and entertainment, today announced its milestone achievement of 1000 active technology patents. This accomplishment underscores V-Nova’s dedication to research and development and its commitment to protecting its intellectual property globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240611724561/en/ V-Nova’s patent portfolio spans more than 50 different jurisdictions. Including over 400 patents in Europe, over 200 in the Americas, over 100 in the United States specifically, and over 200 in Asia. V-Nova forged new directions in data processing to enhance digital experiences, maximize efficiency, reduce costs, and increase sustainability. The company leads the way with key international data compression standards for the video indust
Alipay+ Reveals Top Scorer Trophy Design for UEFA EURO 2024™11.6.2024 09:24:00 CEST | Press release
Alipay+, a suite of cross-border mobile payment and digitalization technology solutions operated by Ant International and an Official Partner of UEFA EURO 2024™, today revealed the trophy that will be awarded to the most prolific marksman at the UEFA EURO 2024™ finale on July 14 in Berlin, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240610328619/en/ The UEFA Top Scorer Trophy presented by Alipay+ is unveiled for UEFA EURO 2024™ (Photo: Business Wire) Sculpted in the shape of the Chinese character “支” (pronounced zhi, and meaning payment as well as support), the trophy reflects Alipay+’s dedication to supporting consumers to enjoy seamless payment and a broad choice of deals using their preferred payment methods while traveling abroad. The character also resembles the fleeting moment of a barefooted striker poised to shoot, evoking the original beauty and power of football – a game that united people across the wo