COVID-19: Institut Imagine and Cerba HealthCare are partnering to test for patients likely to develop severe symptoms

In 2020, researchers at Inserm, Université de Paris, and Assistance Publique–Hôpitaux de Paris (AP- HP), in collaboration with the university hospital organisation Institut Imagine (Hôpital Necker-Enfants malades AP-HP), which has been granted “Institut Carnot” certification through The Rockefeller University and the Howard Hughes Medical Institute in New York, identified the leading genetic and immunological causes responsible for at least 15% of serious forms of Covid-19. Today, this same French and American team, jointly lead by Jean-Laurent Casanova and Laurent Abel* at the Institut Imagine and The Rockefeller University, is joining forces with Cerba HealthCare, a leading stakeholder in medical diagnostics, to transform these discoveries into clinical applications and screen individuals who are more likely to develop a severe form of the disease and tailor their treatment accordingly.

A commonality among 15% of severe cases: impaired type-I interferon activity

At the start of the Covid-19 pandemic, Dr.Jean-Laurent Casanova and his team created an international consortium, Covid Human Genetic Effort, to identify the genetic and immunological factors responsible for the reason some patients experience serious forms of the disease. They focused their research on patients who were hospitalised with severe Covid throughout the world. These patients all had a quantitative or activity-related type-I interferon (type-I IFN) impairment. Type-I interferons are immune system molecules that normally serve a powerful anti-viral function.

In two articles published in the journal Science1,2, researchers discovered changes in genes that were already understood to regulate the immune responses controlled by type-1 IFN, especially in reaction to the flu virus, in 3-4% of patients with a severe form of the disease. These mutations decreased the production of these interferons. In an even more surprising development, they identified an auto-immune reaction in 10-11% of other patients with serious Covid symptoms. These individuals produced autoantibodies that specifically targeted type-1 IFNs. In a recent article published in Journal of Experimental Medicine, these same anti-interferon autoantibodies were also identified as the cause of severe reactions to yellow fever live vaccine in around one- third of patients from an international cohort3, confirming the discoveries of the Imagine teams.

From ground-breaking research to a screening test

These studies have revealed the crucial role of type-I interferons in the immune response against SARS-Cov- 2 and the development of serious forms of the disease. The genetic variants that decrease their production or the auto-antibodies that neutralise their effect are present before the virus infects the body and play a critical role in the outcome of the disease. Some serious forms of Covid-19 could therefore be prevented by testing the general population to detect any auto-antibodies and by administering interferons at the onset of infection for certain patients”, Jean-Laurent Casanova and Laurent Abel explain.

Against this backdrop, Institut Imagine decided to form a partnership and sign its first collaboration agreement with Cerba HealthCare, a leading stakeholder in the fields of medical diagnostics and specialized biology.

Cerba HealthCare’s expertise; knowledge of specialised medical biology, from prevention to screening and diagnostics; and its international network are all major assets. This collaboration will help us reach the next level by transforming our improved understanding of the disease into a concrete application designed to help patients. In reality, we are talking about adapting precision genetic medicine to the context of a pandemic”, says Dr. Stanislas Lyonnet, Director of Institut Imagine.

Jérome Sallette, Scientific Director of Cerba HealthCare, adds, “Our partnership with Institut Imagine perfectly embodies our shared vision of the need to discover diagnostic tools and new treatments at a faster pace, particularly by building more bridges between different ecosystems. The reputation, expertise, and commitment of the teams at Institut Imagine are clearly a driver of success in this project, for which we have mobilised all of our areas of expertise. While the epidemic does lead to a race to innovate, it also underscores more than ever the importance of cooperation between public and private stakeholders.”

For additional information, click here.

*Jean-Laurent Casanova oversees genetics and experimental immunology in both branches, while Laurent Abel directs genetics and mathematical epidemiology in both branches.

 

Sources

1) Inborn errors of type I IFN immunity in patients with life-threatening COVID-19

Qian Zhang et al.
Science, 24 September 2020

2) Auto-antibodies against type I IFNs in patients with life-threatening COVID-19

Paul Bastard et al.
Science, 24 September 2020

3) Auto-antibodies to type I IFNs can underlie adverse reactions to yellow fever live attenuated vaccine.

Paul Bastard et al.
Journal of Experimental Medicine, 2021

 

About AP-HP

Europe’s leading hospital and university center, the AP-HP and its 39 hospitals are organized into six university hospital groups (AP-HP.Center-University of Paris ; AP-HP.Sorbonne University ; AP-HP.Nord-University of Paris ; AP-HP.Université Paris Saclay ; AP-HP.Henri Mondor and AP-HP University Hospitals.Paris Seine- Saint-Denis University Hospitals) and are organized around five universities in the Ile-de-France region. Closely linked to major research organizations, the AP-HP has three world-class hospital-university institutes (ICM, ICAN, Imagine) and the largest French healthdata warehouse (EDS). A major player in applied research and innovation in health, AP-HP holds a portfolio of 650 active patents, its clinician-researchers sign nearly 9,000 scientific publications each year and more than 4,000 research projects are currently under development, all promoters combined. In 2020, AP-HP obtained the Institut Carnot label, which rewards the quality of partnership research : the Carnot@AP-HP offers industrial players solutions in applied and clinical research in the health sector. The AP-HP also created in 2015 the AP-HP Foundation for Research to support biomedical and health research carried out in all of its hospitals. https://www.aphp.fr

About Cerba Healthcare

Cerba HealthCare, a leading player in medical diagnosis, aims to support the evolution of health systems towards more prevention. It draws on more than 50 years of expertise in clinical pathology to better assess the risk of diseases development, detect and diagnose diseases earlier, and optimize the effectiveness of personalized medicine. Every day, the Group’s 8 500 employees through its subsidiaries on 5 continents sustain the transformation of medicine, driven by one deep conviction: to advance diagnosis is to advance health.

Cerba HealthCare, enlightening health.

About Inserm

Inserm is a public scientific and technological establishment, under the dual supervision of the Ministry of Health and the Ministry of Research. Dedicated to medical biological research and human health, it is positioned along the entire path from the research laboratory to the patient’s bed. On the international scene, it is the partner of the largest institutions involved in the challenges and scientific progress of these fields.

About Institut Imagine

In an architecture designed by Bernard Valéro and Jean Nouvel on the campus of Hôpital Necker-Enfants malades (AP-HP), Institut Imagine, which has been labelled Institut Carnot, is the leading center for research, care and teaching on genetic diseases. With the mission of understanding and curing these diseases, the Institute brings together 1,000 of the best doctors, researchers and healthcare personnel in an architecture that creates synergies. This unprecedented continuum of expertise, combined with proximity to patients, enables Imagine to make discoveries for the benefit of patients. The 7,000 or so genetic diseases identified affect 35 million patients in Europe, and nearly 3 million in France, where there are 30,000 new cases each year. Nearly 60% of the children seen in consultations leave without a genetic diagnosis and 90% of genetic diseases do not yet have a cure. Faced with this major public health problem, the challenge is twofold: to diagnose and to cure. www.institutimagine.org/fr

About Université de Paris

As a research-intensive, multidisciplinary university, the University of Paris ranks among the most prestigious French and international institutions thanks to its high-level research, its excellent higher education programs, its support for innovation and its active participation in the construction of the European research and education area.

The University of Paris has 61,000 students, 4,500 professors and researchers, 22 doctoral schools and 142 research laboratories. Visit u-paris.fr.

Cerba Research Announces Time-Saving COVID-19 Exploratory Tools and NGS Advancements

  • Enhance viral load measurement for SARS-CoV-2 using digital droplet PCR
  • Enable whole-genome sequencing in NGS of the SARS-CoV-2 and other respiratory viruses

Cerba Research announces today that it has developed two new COVID-19 exploratory tools to enhance clinical research for the development of vaccines and treatments for COVID-19 and other infectious diseases. Developed by scientists at Cerba Healthcare on nasopharyngeal ongoing patient samples, these tools are available and efficient on clinical specimens. Furthermore, this whole-genome sequencing in NGS assay is available for other viruses responsible for respiratory diseases like influenza viruses.

The developments reinforce Cerba Healthcare and Cerba Research’s scientific commitment to the continued fight against the pandemic. Cerba Research recently announced its In Vitro Diagnostic (IVD) division supported The French Public Health Agency (Santé Publique France) in a prospective COVID-19 seroprevalence study now identified as a major partner for epidemiological studies with the French Government.

“Since the onset of the pandemic, Cerba Healthcare has been at the forefront of fighting against COVID-19 with all stakeholders, including patients, healthcare professionals, governments, IVD professionals, and pharmaceutical and biotechnology companies developing vaccines and treatments. Our new COVID-19 exploratory tools help our clinical research customers develop more tailored and effective treatments,” said Jérôme Sallette, chief scientific officer at Cerba Research.

Further information:
Viral load measurement for SARS-CoV-2 using digital droplet PCR

  • Use in treatment and vaccine trials
  • An innovative method enabling SARS CoV-2 absolute quantification
  • Increased sensitivity and precision as compared to qPCR assays, especially in low viral abundance samples
  • Follow-up of patients with low viral load
  • Accurate assessment in viral load variation
  • Performed in an ISO15189 accredited lab

Whole-genome sequencing in NGS of the SARS-CoV-2 and other respiratory viruses

  • Use in treatment and vaccine trials
  • Viral determination and subtyping (SARS CoV-2, influenza, RSV, adenovirus, pneumovirus, rhinovirus)
  • Detection of virus mutations
  • Assessment of viral heterogeneity and quasispecies
  • Precise detection of co-infections (e.g., influenza subtype)
  • Documentation of proven reinfections
  • Can be combined to host genetics to address individual genetic susceptibility to infection, level of the immune response, or severity prognosis factors

Cerba Xpert plays essential role in the French response to COVID-19

In March 2020, when the global COVID-19 pandemic rapidly moved through the population, the French government decided to lockdown the movement of people to stop the spread, as collective immunization was not an option.

The French Public Health Agency of the Ministry of Health (Santé Publique France) commissioned a study for the serology, prevalence, and evolution of COVID-19 in the French population, including French overseas nationals. The study objective was to monitor the collective immunization, and specifically map the immunization rate by department, region, age and gender over time, looking at the expression of antibodies.

Cerba Xpert (part of Cerba Research) was selected among other companies to conduct this study due to the wide lab network of the Cerba Healthcare* Group which provided a unique capability to prospectively collect and provide thousands of samples before, during and after the French lockdown.

To meet the study objectives in the shortest time possible, Cerba Xpert deployed additional human resources focused on a 24/7 operation. This agility enabled us to scale up our operations to meet the demands of the intense sampling seen with the rising infection rates, using the PCR test result.

By harnessing the Cerba Healthcare laboratory network and Cerba Xpert, the IVD division of Cerba Healthcare, Santé Publique France will be positioned to publish the results of the study this November. The outcomes of the study will provide insight, allowing the French government to adapt its future strategy in the fight against COVID-19.

Cerba Xpert is now identified and referenced by the French government as a major partner for epidemiological studies. We are honoured to have played a pivotal  role in the fight against COVID-19 and we are ready to pursue our partnership for 2021.

*Cerba Healthcare is an international network of medical biology laboratories that offers a complete solution in terms of biological diagnostics ranging from the collection centre to the specialty laboratory.

Covid-19 samples available through Cerba Research IVD Division

In light of the global COVID-19 pandemic, the need for testing has become urgent and critical.  Cerba Research IVD, together with Cerba Laboratories, is widely using SARS-CoV-2 diagnostic tests to detect the virus in patients.

The national epidemiological situation has undergone changes demanding measures in favor of multiple diagnostic tests with health care providers who are capable of receiving large numbers of samples for the diagnosis of COVID-19.

As a major player in public health in the specialty diagnostics sector for more than 50 years, Cerba is receiving COVID-19 samples and performing 4000+ SARS-CoV-2 tests daily.

With the agreement of the French Health Directorate (DGS), we are performing COVID-19 diagnostic tests for confirmation of positive cases in the support of the CNR responsible for respiratory infections at the Institut Pasteur (Paris).

With our expansive access to patient samples, Cerba Research IVD can help support the development of diagnostics tests for both molecular and immunological assays.

For COVID-19 samples – nasopharyngeal (NPS) or serological samples, please contact our team at secretariat@cerbaxpert.com.

For COVID-19 assay validation – testing evaluation or method comparison testing – please contact our team at secretariat@cerbaxpert.com.

 

Additional Resources:

BIOLOGICAL MANAGEMENT SARS-COV2 (COVID-19)

Possibilities of substitution of the recommended transport medium M4RT to transmit my COVID-19 samples

Cerba Research Proud to be part of Government Task Force in combat against Covid-19

The Belgian Taskforce to combat Covid-19 has taken off! Cerba Research and sister company, CRI, have engaged to be a vital part of the government-led consortium, alongside PPD, JnJ, GSK, Biogazelle, UCB ULiège, Sciensano, ThermoFisher, UgenTec and MIPS. Together, we will work to upscale Covid-19 testing in Belgium.

Led by Federal Minister Philippe De Backer, the members of the task force will work to increase testing against Covid-19, an important tool in tackling the further spread of the virus, in order to flatten the curve. Cerba Research, the central lab division, with its Headquarters in Ghent, Belgium, is providing the logistical support and organization for this project and this way plays a pivotal role in the delivery of patient samples to pharma and academia for Covid-19 testing. We are very grateful to be part of this consortium and wish to thank all the other members for the seamless collaboration for this ambitious project. Speed and efficiency were of the essence, as the project only started few weeks ago and took off today!

Mario Papillon, CEO of Cerba Research, states: “The Covid-19 pandemic is heavily impacting our society, and we must work together to overcome the situation. Cerba Research is proud to join efforts with the Belgian government, Biogazelle, GSK, JnJ, UCB and PPD to significantly improve testing capabilities to our elderly living in nursing homes.

As described in the news (VRT) today, the first nursing homes have already received testing kits for their residents.

You can watch the news here. The testing kits being delivered to the nursing homes is the first headline. For those of you who do not speak Dutch, please find the transcript of the video below.

Transcript news

The first Flemish nursing homes have received material from the government to test their residents for covid-19. 85 care centers will receive a total of 11.000 test kits. In 55 of these nursing homes residents have already tested positive, whereas in the other 30, no covid-19 cases have been confirmed. One of these nursing homes is De Weister in Aalbeke, a sub municipality of Kortrijk. Yesterday, 45 tests arrived there. However, it is still unclear when exactly the residents will be tested, as the nursing home does not determine this.

“What does it contain? It contains a surgical facemask, an apron, and the kit itself which contains gloves and the actual test.”

45 of these test kits were delivered here yesterday, 1 for every resident of the nursing home. When exactly they are tested will be determined by “Zorg en Gezondheid”, and not by the nursing home itself.

The care center was randomly selected as research place, as there have been no confirmed cases yet. In any case, the family members are relieved that every inhabitant will be tested.

Partner, Teddy Lab, selected as central lab for Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19

We are proud to announce that our partner in China, Teddy Lab, has been selected as the authorized central lab for a Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19. On March 18th, the results were published in the New England Journal of Medicine (NJEM).

Read the full article here.

Business Continuity Plan – Coronavirus (COVID-19)

Cerba Research continues to monitor the global COVID-19 pandemic and we have an established team of experts who review our business operations on a daily basis and implement actions to respond to changes in the global environment. We are committed to ensure business continuity to support our biomarker, central laboratory and in-vitro diagnostics services and ensure the well-being and safety of our employees, our customers, investigator sites and the participants. We continue to review the updated guidance from the World Health Organisation (WHO), the Centers for Disease Control (CDC) and national and government organisations and adapt our business continuity plan as the situation evolves.

We have taken the following actions to mitigate risk and maintain business continuity;

  • Flexible and home working arrangements for all office-based employees in all our affiliates.
  • For our sample handling, kit building, logistics, warehouse and laboratory staff, additional safety measures have been implemented and rotational working arrangements to allow business continuity.
  • In the event any of our affiliates cannot continue operations due to government mandated closures, we will communicate updates to any impacted sites and customers.
  • Implementation of a travel advisory and all employees will not be permitted to travel, unless extreme circumstances require it.
  • We continue to monitor courier services and contingency plan to minimize any disruption to our customer base. Please note, the situation is very dynamic and is subject to change at any given time. We have confirmed all couriers have contingency plans in place and are using all necessary means to offer service. We are enacting our own contingency plans to ensure we have solutions in place should the current/standard courier be unable to deliver. In the event there are impacted areas within country where couriers are not able to access sites due to government mandated closures, we will provide updates to sites via the local courier offices and communicate updates to sites and customers.
  • All sites will be provided a communication update this week and advised to contact their local courier office to check the latest information on sample collection services before scheduling their patient visits. All sites will also be requested to check the Cerba Research website for the latest information related to our operational services.

If you have any questions or require assistance, please contact your Cerba Research Project Manager.

Communication on Coronavirus (COVID-19)

Cerba Research is closely monitoring updates related to COVID-19 and will implement processes to ensure smooth running of all biomarker, central laboratory and in-vitro diagnostics services during this time, as needed. These processes are focused on the well-being and safety of our employees, our customers, investigator sites and the participants.

As of today, we are continuing to operate as normal; Cerba Research is in close communication with couriers to ensure timely follow up of collection and transportation of test samples and will communicate for affected areas where needed.

According to the World Health Organisation (WHO) Director General’s Opening Remarks at the weekly mission briefing on COVID-19 on 4th March, the WHO has raised its assessment of the risk of spread and the risk of impact to very high at the global level. This link provides more information from the briefing.

In response to this assessment;
• Actions have been taken to protect Cerba Research staff and ensure business continuity.
• Cerba Research have implemented a travel advisory and all employees globally will not be permitted to travel, unless extreme circumstances require it.
• All employees have received training and guidance on personal protection measures.
• Regular internal and external updates will be provided as needed as we continue to monitor the situation.