FDA Issues an Emergency Authorization to a Blood Purification Device for Treating COVID-19 Patients

The U.S. Food and Drug Administration (FDA) has issued an emergency authorization to a new device that might treat COVID-19 patients. This device is a blood purification tool that could be used on an adult COVID-19 confirmed patient with severe respiratory symptoms. It would be available in major intensive care units  (ICU) of the leading hospitals in the US.

This device works by reducing the number of body’s inflammatory mediators such as cytokines. Cytokines are small protein fragments inside blood that govern the immune response of a cell. It filters the blood of the patient. Usually, these proteins are elevated when a person is infected and it could even cause a “cytokine storm” in a COVID-19 positive patient. Such a patient suffers from extreme inflammation that could lead to a rapid shock, respiratory or any organ failure, eventually causing death.

Stephen M. Hahn, Commissioner FDA says; “We continue to work across all sectors to expedite the development of numerous innovative potential preventive and treatment approaches by both facilitating emergency access for patients, to the extent we can, and supporting the evaluation of potential therapies.”

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He further added that; “With today’s authorization of a blood purification device, we are expediting the availability of a treatment option for patients in the ICU to help reduce the severity of the disease. Our staff will continue our around the clock review of all medical products to expedite the availability of treatments to help fight this devastating disease.”

This emergency use authorization from U.S.FDA  has been issued to “Terumo BCT Inc”. and “Marker Therapeutics AG” for their “Spectra Optia Apheresis System” and “Depuro D2000 Adsorption Cartridge device”.

In Europe, this antibody detection bases systems are also developed to improve the diagnostics. EUROIMMUN AG is the pioneer company to offer such a model to show its support for all COVID-19 positive patients.

All these tests are extremely helpful to identify patients who have contacted coronavirus lately. It ensures a shorter tracking period and also records the recovered patients as they develop immunity against SARS-CoV-2.

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The Fraunhofer Research Institution for Marine Biotechnology and Cell Technology EMB from Germany is supporting the EUROIMMUN AG system for its generous efforts to develop new serological tests for improving  COVID-19 diagnosis.

Dr. Wolfgang Schlum-berger, the executive head of EUROIMMUN AG says that producing these antigens that are currently using in this test system is a complicated, long and difficult process, which is why the company is gratified on this collaborative project with Fraunhofer EMB. With this combined effort, the process would speed up and they would be able to handle the expectations of everyone and develop these  “Anti-SARS-CoV-2 ELISA test kits” for the whole world.

Professor Reimund Neugebauer from Fraunhofer-Gesellschaft hopes that this partnership would be fruitful, saying that it feels like working on the frontline during this coronavirus pandemic. All the experts at Fraunhofer are working at their best to make this project successful. The test kits production on a large scale would make these kits available for all the suspected patients globally. He is hopeful that this joint venture is a significant contribution to control the deadly pandemic which has taken more than 90,000 lives till the date.