Celltrion Healthcare to expand COVID-19 testing portfolio to include both antigen and antibody testing kits

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Celltrion Group announced plans to expand its diagnostic portfolio for SARS-CoV-2, the virus causing COVID-19, in its efforts to improve access to COVID-19 testing and help prevent the further spread of coronavirus infection worldwide.

Celltrion has completed development of a point-of-care antigen testing (POCT) kit for COVID-19 together with South Korean healthcare company BBB, which specialises in blood testing and lab-on-a-chip technology. The POCT kit is a portable and highly sensitive device for use in rapid point of care testing to support early detection of COVID-19 positive patients in clinical settings.

Promising early results for a prototype of Celltrion’s POCT kit for COVID-19 showed more than 95% sensitivity. The kit uses lab-on-a-chip technology consisting of a microfluidic electrochemical biosensor which aims to give fast and accurate results. The kit is designed to show results within 15-20 minutes, and Celltrion anticipates receiving a CE mark in Europe later this month, ahead of the expected launch in July.

Celltrion has also entered into a distribution agreement with Humasis, a South Korean in-vitro diagnostic company, to distribute and sell a rapid diagnostic test globally this month. This test is a COVID-19 rapid antibody diagnostic test (RDT) kit, which could offer a cost-effective option and can be used by hospitals to confirm patients to be discharged. Celltrion and Humasis will also cooperate in the development of an upgraded rapid antibody diagnostic test and a rapid antigen diagnostic test, for which Celltrion will apply its proprietary COVID-19 antibody- antiviral technology to enhance detection sensitivity. Celltrion plans to leverage its advanced therapeutic technologies to expand the range of co-developed diagnostic devices beyond SARS-CoV-2 to a number of other infectious diseases as it progresses cooperation with Humasis.

“We are keen to drive early diagnosis of COVID-19 through the availability of our testing portfolio,” said Ki-Sung Kwon, Head of R&D Unit at Celltrion. “We have successfully built solid partnerships with local device companies that are prominent in the field of diagnostic testing. We are committed to providing flexibility for testing needs as the pandemic evolves, and are using our expertise and past experience developing antibody treatments and targeting coronaviruses to fight this pandemic.”

About Celltrion Healthcare

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries.