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Viracor Eurofins received FDA EUA for its RT-PCR SARS-CoV-2 Virus LDT.

Eurofins Genomics expands capacity for probes and primers production for RT-PCR SARS-CoV-2 test kits

Eurofins Technologies, a fast growing provider of diagnostic technologies in the field of immunoassays and molecular detection methods, announces the launch of a range of testing kits for serology-based antibody detection by ELISA of patients who have been exposed to COVID-19. The development of the assays has been spearheaded by affiliate companies Gold Standard Diagnostics Inc., Virotech Diagnostics GmbH, NovaTec Immundiagnostica GmbH and Ingenasa (Inmunologia Y Genetica Aplicada SA). Those specialized diagnostic technologies companies are well-established providers of testing solutions with a strong focus on scientific excellence in infectious diseases testing and immunology. The first ELISA assays are expected to receive CE-IVD mark by 16 April 2020 and will also be submitted to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA).

Viracor Eurofins received FDA EUA for its RT-PCR Laboratory-Developed Test (LDT) for SARS-CoV-2 on 06 April 2020. More information can be found on https://www.viracor-eurofins.com/about-us/newsroom/news-items/viracor-eurofins-receives-emergency-use-authorization-eua-from-the-us-food-and-drug-administration-fda-for-its-sars-cov-2-rt-pcr-laboratory-developed-test-ldt/.

Due to the increasing global demand and worsening supply chain issues, Eurofins Genomics’ six oligonucleotides production sites in the U.S., Europe, India and Japan are increasing their capacity to produce probes, primers and positive controls, which are key components for RT-PCR testing of SARS-CoV-2. 

Multiple solutions to support health authorities in their fight against COVID-19

A comprehensive product portfolio is essential to support the tremendous efforts of health authorities working on SARS-CoV-2 detection and COVID-19 control all over the world. Over the last six weeks, in close collaboration with leading research hospitals and many of Eurofins human clinical testing laboratories around the world, Eurofins Technologies teams have worked diligently to develop a broad range of testing methods to support healthcare providers around the world.

According to experts, there is a large range of applications for serologic testing. Serology can be used to complement the PCR swab testing that detects the virus to help diagnose acute infections status and its evolution. It can help estimate the timing of infection. As knowledge develops about the immunity to potential reinfection of patients having previously contracted COVID-19 and recovered, antibodies testing may provide information about statistically reduced contagion risks of and from these persons. It could help identify donors of plasma from recovered patients that can be transfused into COVID-19 patients as a potential treatment. Long-term, serologic tools can contribute to discriminating between vaccine-induced antibodies and natural infection. As the pandemic unfolds, serosurveys can enable tracking closely what percentage of the population has become infected in each city or region. Serosurveys may also help efforts to develop vaccines and therapies.

The following products will be released shortly to leading reference centres and hospitals around the world:

Serology – Antibody tests for IgG, IgM, and IgA with very good specificity and sensitivity will be released for use on any open ELISA platform.

Lateral Flow – As an additional option with fast turnaround time, an easy-to-use rapid lateral flow antibodies test is under final development and validation.

Automation – Gold Standard Diagnostics offers a suite of instruments for the seamless automation of ELISA assay testing in any laboratory.

Molecular Diagnostics – A range of RT-PCR tests for the qualitative detection of SARS-CoV-2 have been developed by Eurofins laboratories around the world. These tests are designed to meet the region-specific requirements for COVID-19 targets. Viracor Eurofins received FDA Emergency Use Authorization (EUA) for its SARS-CoV-2 Laboratory Developed Test (LDT) on 06 April 2020. Other Eurofins laboratories around the world have developed alternative RT-PCR options to meet local regulatory obligations and mitigate reagent supply chain issues so Eurofins can continue to significantly increase the testing capacity it offers to health authorities fighting the disease.

Probes and Primers for RT-PCR – Eurofins Genomics is also supplying primers and probes to a large number of laboratories and clinical diagnostic developers around the world to form an essential part of their RT-PCR testing solutions. Eurofins Genomics’ six Oligonucleotides production sites around the world are increasing capacity significantly to meet the growing demand and help clinical diagnostic manufacturers and laboratories mitigate supply chain issues.