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.
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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/
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