Eurofins Bioanalytical Services Blog

The world is entering a new era of the COVID-19 pandemic in which there is an increasing call for reliable antibody testing. Conventional neutralising antibody serological testing requires the use of a live virus conducted in a Biosafety Level 3 (BSL-3) laboratory, which presents challenges for COVID-
19 development programmes. An alternative approach is the use of a surrogate virus test (sVNT) that removes this obstacle and is the first neutralising antibody serology test to
receive emergency use authorisation (EUA) from the FDA. This innovative assay detects the presence of neutralising/ blocking antibodies against the SARS-CoV-2 virus, that block the interaction between the receptor-binding domain (RBD) of the viral spike glycoprotein and the ACE2 cell surface receptor.

Current testing methods, such as PCR, determine whether someone is actively infected by confirming the presence of
viral material or IgG/IgM antibodies that detect (binding and blocking) induced immune response from exposure to the
virus. Being an ELISA methodology, the in-house, fully validated surrogate virus neutralisation test (sVNT) is
amenable to high-throughput testing, at a lower analytical cost, and requires no extended validation timelines for
Eurofins’ client base. It also removes the obstacle faced by many COVID-19 development programmes, by eliminating
the requirement for a Biosafety level 3 containment.

The advantage over historic antibody IgG/IgM tests is that this new gold standard assay tests for neutralising
antibodies (versus binding antibodies), by confirming neutralising function without the need for a secondary
antibody and is isotype and species independent. As the world strives to combat the COVID-19 pandemic,
Eurofins is committed to being part of global solution by expanding capacity to develop reagent kits and investments
in nonproprietary assays to offer for industry COVID-19 analytical Nab testing.

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It was early 2020 when the head of Moderna’s vaccine development team first met with Eurofins Viracor. Moderna scientists were working feverishly to move their COVID-19 vaccine candidate programme into the clinical phase, but their laboratory partner did not have all the validated assays ready to meet the needs of the trial. Eurofins Viracor was also gearing up to enter the fight against the COVID-19 pandemic with the launch of their new Coronavirus (COVID-19) SARS-CoV-2RT-PCR test.

A qPCR assay that the US Food and Drug Administration (FDA) would later show to have the highest sensitivity of any they evaluated. Not having worked with Eurofins Viracor previously, Moderna was understandably skeptical about partnering
with someone new for such a high-stakes project. So much so that they lined up backup providers in case Eurofins Viracor was unable to meet their clinical testing needs. But Eurofins Viracor didn’t fail. After developing a sensitive and robust quantitative polymerase chain reaction (qPCR) assay for Moderna’s study, that was bridged to their EUA assay, the Eurofins Viracor
laboratory team performed over 2,000 Phase II tests, and more than 85,000 tests (on NP swab and saliva samples) to support their >30,000 subject Phase III trial; matching Moderna’s intensity and proving that their newly chosen molecular testing partner was equal to the task.

The two organisations worked closely and collaboratively, in a joint response to the COVID-19 pandemic, performing essential laboratory testing to assess the efficacy of the Moderna vaccine candidate against novel coronavirus infection. The ultimate result was the successful completion of Moderna’s clinical trial for the mRNA-1273 COVID-19 vaccine candidate, and emergency use authorisation (EUA) by the US FDA on December 18, 2020, with subsequent approvals by regulatory agencies around the globe.

Without the accurate and reliable molecular testing Eurofins Viracor provided, the Moderna trial could not
have met the aggressive timeline needed for regulatory submission and approval for their COVID-19 vaccine. As the Moderna vaccine continues to be distributed around the world to thwart the spread of the deadly COVID-19 virus, the Eurofins Viracor team looks back with pride at the contribution to its success and are humbled by the impact it will have on the health and safety of millions of people across the world.

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Eurofins donates 100,000 fast PCR tests to detect SARS-CoV-2 variants B.1.1.7 (ex. UK), B.1.351 (ex. South Africa) and B1.1.248 (ex. Brazil) to hospitals around the world

Eurofins is making new assays for the identification of B.1.1.7 (UK) and B.1.351 (South Africa)/B.1.1.248 (Brazil) variants with a one hour run time available for free to public health institutions who do not have capabilities to rapidly identify the presence of these variants.

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Eurofins BioPharma Services recently launched a validated antibody assay against the SARS-CoV-2 virus; Surrogate Virus Neutralization Test (sVNT). This innovative assay detects the presence of neutralizing/blocking antibodies against SARS-CoV-2 virus, that block the interaction between the receptor-binding domain (RBD) of the viral spike glycoprotein with the ACE2 cell surface receptor. Fast and automatable, the fully validated sVNT assay is amenable to high-throughput testing at a lower analytical cost requiring no extended validation timelines for our clients.  

Additionally, Eurofins was granted an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for SARS-CoV-2 RT-PCR testing in support of clinical trials for COVID-19 vaccine and therapeutics development. The FDA developed a reference panel for RT-PCR testing to assess the performance of molecular tests. Data from the FDA SARS-CoV-2 Reference Panel demonstrates that Eurofins truly offers best in class solutions in the laboratory services marketplace, outperforming well-respected In Vitro Diagnostic (IVD) reagent kit manufacturers and other Laboratory Developed Tests (LDT) in house. 

Eurofins Bioanalytical Services, a member of Eurofins BioPharma Services, Laboratory Testing division, announces the launch of a Surrogate Virus Neutralization Test (sVNT) antibody assay against the SARS-CoV-2-virus. An alternative to conventional testing with a live virus, this assay is the first neutralizing antibody serology test authorized by the FDA as emergency use authorization (EUA). This innovative assay detects the presence of neutralizing/blocking antibodies against SARS-CoV-2 virus, that block the interaction between the receptor-binding domain (RBD) of the viral spike glycoprotein with the ACE2 cell surface receptor.

Eurofins Bioanalytical Services expands its technology footprint with the 25 fluorescent channel Novocyte Quanteon^TM Flow Cytometer.

For the 2020 CRO Leadership Awards, Life Science Leader magazine once again teamed up with Industry Standard Research (ISR) to determine the award recipients. More than 60 contract research organizations were assessed on over 20 performance metrics in ISR's annual CRO Quality Benchmarking survey. Eurofins is recognized as a recipient of these awards, exceeding customer expectations in Quality, Capabilities and Compatibility.

Eurofins Bioanalytical Services expands its technology footprint in Flow Cytometry with the addition of Novocyte Quanteon™. The flow cytometer provides an expanded set of capabilities that accommodate today’s high-end and increasingly sophisticated multi-color flow cytometry assays. 

Expert Interview

In this Bioanalysis Zone interview, David Lanham of Eurofins BioPharma Services discusses flow cytometry for pharmacodynamic biomarker analysis and receptor engagement in early clinical stage work. David also explains the challenges faced when using flow cytometry as an analytical tool, before sharing his thoughts on the progress that has been made to regulate and standardize the field.