RACE TO THE COVID-19 SEROLOGICAL TESTS: The winning partnership of two French Companies, bioMérieux and e-Zyvec.

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March 2020 will be remembered as this time when Europe braced itself against the outbreak of COVID-19. The spread of a new and poorly known coronavirus triggered countries to apply several social and economic measures to protect populations as best as possible. The healthcare community is used to fighting off well known pathogens for which an arsenal of diagnostics and therapeutics solutions are available. But the novel SARS-CoV-2 responsible for COVID-19 caught everybody by surprise and therefore unequipped for this fight. As a temporary measure, most of the countries asked their population to stay confined at home to limit the spread of the virus. Lockdown enabled healthcare systems to manage infected people in the best conditions as possible, but this extreme solution could not be a long term one. A return to a balanced and healthy lifestyle required the scientific community to develop the diagnostic tools in a historically short timeframe. Below is the story of how two French companies efficiently collaborated towards this crucial goal.

bioMérieux has been a major global player in the field of diagnosis of infectious diseases for more than 55 years. True to its public health mission the Company decided at the early onset of the epidemic to start working on the development of diagnostic tests for the detection of the SARS-CoV-2 virus responsible for the COVID-19 disease. bioMérieux’s strategy is primarily based on the launch of three complementary molecular biology tests as well as its continuing expertise in automated nucleic acid extraction and on its capability in immunoassays with the launch of two serology tests (IgG and IgM) on its VIDAS® instrument.

It is a rapid, accurate and automated solution for immunoassays diagnostics that is very well adopted by laboratories.

The development of new assays with high performances needs specific biomolecules such as antibodies, antigenic peptides and recombinant proteins. With a long-standing experience, bioMérieux R&D biomolecule engineering team designs, produces, and characterizes such biomolecules internally. Due to the complexity of this new Coronavirus, bioMérieux worked with human cell expression systems to allow screening of several antigens with native and complex structures required for specific antigenic properties. Expression vectors engineering and optimization is indeed a key factor for the development and the manufacturing of performant critical recombinant proteins used in immunoassays.

e-Zyvec is a 3 years-old start-up based in Lille. Spinning-off the Lille University and the CNRS, it was founded to bring an innovative service in biological and genetic engineering to both academic research laboratories and industrial biotech companies. e-Zyvec innovation relies on the exploitation of a proprietary method of DNA assembling, enabling fast and accurate generation of molecular tools called DNA vectors. Such DNA vectors are essential to produce artificial proteins in biological systems such as the viral antigens needed to develop the serological tests.

In the starting blocks

First contact to collaborate on SARS-CoV-2 project was made on the 18th of March.

Since the scientific communities started to point out the possible interest of serology test to fight the pandemic, bioMérieux began to study and design several SARS-CoV-2 antigens that would be used in the development of serological diagnostic tests. First challenges were to produce and screen many different antigens in a very short period.

“Relying on the expertise of e-Zyvec in vector assembly , innovative proposals and ability to rapidly provide us expression vectors, experienced in other recent projects, we proposed e-Zyvec to collaborate with us on SARS-CoV-2 antigens development for our serology project in this urgent context and critical healthcare crisis,”

Maxime Combe, R&D Scientist at bioMérieux.

 “As everybody else at this time in France, we were, as a company, dealing with all the lockdown measures to be taken to protect our team members while ensuring business as much as possible. bioMérieux’s proposal immediately triggered our will to be part of the response to the outbreak. It made a lot of sense to everybody in the team, so we jumped in without any second thought”

Sylvain Julien PhD, e-Zyvec Chairman.

Keeping the pace

Very quickly, on-line meetings succeeded each other to define the scientific strategies and validate the designs of the DNA vectors to be constructed. Both companies engaged in a close partnership to deliver a serial production of vectors, each series answering specific questions: what would be the best recognized viral antigen? What would be the best expressing vector? Can we further optimize them?

« We particularly appreciated e-Zyvec team members availability during this important project and also their ability to provide us 3 successive vectors generations in only 15 days starting from the plasmid maps approval to the onsite receipt. Finally, 23 different antigen candidates were screened in human cells to select SARS-CoV-2 antigens in native-like conformation, leading to the extremely high immunoassay performances as well as a high expression yield and high final purity.”

said Soizic Daniel. PhD, R&D ImmunoAssays Senior Manager (bioMolecule Engineering) at bioMérieux

“We had already worked together by the past. It made things smoother. The bioMerieux’s R&D team explained their needs and decisions to us very openly and their administrative department was very efficient to ease the paperwork processes. There was a lot of mutual trust that allowed us to entirely focus on achieving the goal and maximize our collective performance.”

Sylvain Julien PhD,  e-Zyvec Chairman.

The finish line!

Since Mid-May, bioMérieux officially commercializes 2

VIDAS SARS-CoV-2 tests (IgM & IgG) that are CE-marked. Both VIDAS® anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG provide results in less than 30 minutes and demonstrate excellent performance on a large number of clinical specimens, with 99.4% and 99.9% specificity, respectively.

“The ability of e-Zyvec to provide several vectors versions in a very short time frame allowed us to produce a panel of recombinant antigens that were screened for their antigenic properties and finally to release rapidly innovative diagnostic solutions in this worldwide health crisis context. The strong commitment of both teams, fruitful collaboration and positive mindset reinforced motivation to face this important challenge.”

Maxime Combe, R&D Scientist at bioMérieux.

“To tackle this challenge, we had to be agile. We re-organized our internal processes to provide fully sequenced assembled vectors in shorter time than usual while maintaining excellent quality level. We are now able when needed, to offer a performant fast-track management to our customers.

Each member of the e-Zyvec’s staff is particularly proud to have seized this opportunity to make a stand during this challenging time. We are very happy that our technological know-how as well as our scientific expertise were recognized by bioMérieux to complete this specific yet essential task: the generation of several DNA vectors for recombinant viral antigen production. During this special period, everybody was lifted by the collaborative spirit and the common goal to contribute to the fight against the pandemic.“

Carine Morel, e-Zyvec Director.

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