SARS-CoV-2 ELISpot: a New Test in the COVID-19 Diagnostic and Vaccine Arsenal

What is an ELISpot Assay?

The assay consists of measuring the specific cellular response against more than 250 peptides of the SARS-CoV-2 Spike (S) and Nucleocapsid (N) proteins by quantifying the number of interferon-producing T cells. The lymphocytes of ill or vaccinated patients are isolated and then brought into contact with the virus antigens. After 20 hours of incubation, the production of interferon is measured. A positive assay allows differentiating the immunity related to infection with the virus (testing positive for anti-SARS-CoV-2 S-protein and N-protein antibodies) from the immunity related to vaccination (testing positive only for anti-SARS-CoV-2 S-protein antibodies).

Download the flyer to learn more.

Conducting Clinical Trials During COVID-19: Lessons for the Next Pandemic

The coronavirus is not the first infectious disease that has forced clinical trials to adapt. Zika, Ebola, and other diseases called for the world to adjust and collaborate global research efforts. With COVID-19, the rapid spread and impact on global healthcare systems forced us to change our trial management and accelerate our processes like never before. The global research community have already discovered and developed several tests and vaccines in record time through collaboration. Yet we are still working on predictive biomarker testing to identify people who are at the most risk of developing severe symptoms, epidemiological, vaccine, and genetic studies.

To facilitate testing, research, and innovation and to ensure trials continued, Cerba Research and Cerba Healthcare adapted our capabilities and facilities to push research continuity.

Register for this webinar to learn the answers to these questions:

  • Did we succeed, how fast did we adapt, and are we ready to face a new pandemic crisis in the future?
  • How did we maintain the high security and confidence of testing, and what did our reactivity and proactivity mean in the context of a health crisis?

Webinar: Leveraging Medical Laboratory Data for Patient Recruitment

Connecting real-world laboratory data from clinical sites and digitalizing patient data – the power of Decentralized Clinical Trials (DCT) to change the trials of tomorrow

Digitalization continues to provide an impetus to move away from centralized, high-cost and difficult-to-access settings to more virtual, patient-centric and decentralized clinical trial (DCT) models. Our methods need to be more patient-centric, and we need to collaborate to find remote solutions.

Thanks to digitization, we can now decentralize clinical trials and put patient data in front of research success. In partnership with Biokortex, Cerba Research will show participants of this webinar a picture of the future: how clinical trials will look tomorrow. New technologies allow us to imagine a whole new process for drug development and assays. This new way of thinking reduces costs and enhance access to data.  The world is evolving fast, and we need to develop accordingly. Agility, adaptability and digitization need to be the new keywords for a more manageable and secure development.

Watch the recording of our webinar held in April 2021 to learn more!

Pediatric Phase I/II Clinical Trial on Mucopolysaccharidosis type III (MPSIIIA)

Lab support for a global pediatric trial for the rare genetic neurodegenerative disorder, Mucopolysaccharidosis type III. Cerba Research provided safety testing, sample management, and specialized testing in our histology lab. Read the case study to discover more details.

Pediatric Phase I/II/III Study in X-Linked Myotubular Myopathy (XLMTM)

Lab support for a global pediatric trial for the rare neuromuscular disease, Myotubular Myopathy. Cerba Research provides safety testing, PBMC isolation, biomarkers, and sample management for the clinical trial. Read more on the challenges and solutions in the case study.

The Complexity of Myeloid-Derived Suppressor Cells in Non-small Cell Lung Cancer: A Combinatorial Multiplex IHC and Flow Cytometry Approach

Presence and Capabilities – Running Clinical Trials in Australia Infographic

Lab Support for the Largest Global Phase III NASH Study to Date

In Light of NASH: Liver Biopsy Optimization Webinar

Liver biopsies are the gold standard for Non-Alcoholic Steatohepatitis diagnosis and thus essential to NASH clinical trials, yet obtaining them is invasive, can be painful and comes with risk of complications. Making optimal use of these valuable samples is therefore critical.

In this webinar, our experts will highlight possible ways to get the most out of liver biopsies and moreover, provide an overview of alternative methodologies.

The presenters will discuss available stainings of liver biopsies for diagnosing NASH, how alternative and innovative imaging can facilitate pathologists’ reading of the samples and how the placebo effect can impact study results. Together, they will lead the discussion on how to determine the best process for trials and boost the optimal use of liver biopsies for studies.

Speakers

Fanny Estermann, PhD, Biomarker Study Team Leader, Cerba Research Montpellier

Fanny Estermann holds a PhD in Biology. She conducted successfully her work on oncolytic viruses at Salk Institute for Biological Studies (La Jolla, CA, USA), paving the way for a new type of targeted cancer therapy. As a specialist in cancer research, she then worked on senescence, cancer and metabolism at the Cancer Institute of Montpellier (ICM, France). She focused her work on metabolism dysfunctions and its consequences in the global health and cancers. She then joined the Montpellier’s University Hospital center (IRMB, France) to develop cutting-edge stem cell, cancer and senescence techniques. After gathering extensive experience in cancer research, stem cells and metabolism, she received a degree in Clinical Trials from the University of Medicine of Montpellier before joining Cerba Research, as Biomarker Study Team Leader and Regional Head of Project Management. Her main goal with her team is to deliver high quality results to clients by designing and conducting custom scientific projects to fit clients’ needs in preclinical and clinical trials. She has been closely involved in the management and development of Cerba Research biopsy processing and new stainings. She is a direct interlocutor of many NASH KOL.

Manon Motte, Head of Image Analysis, Cerba Research Montpellier

Graduated as Master in Skin Biology at the University of Lyon, Manon worked for more than 7 years in the pharmaceutical industry in a Morphology Histologic team (R&D department) for Dermatological projects. She has a strong experience in the implementation of transverse Histology/Omics technology as well as in the validation of Image analysis applications (Pre-clinical and clinical Studies). Manon is also a specialist in histological techniques and related processes. Today, Manon has chosen to extend her experience in the histology and immunohistochemistry department of Cerba Research as an imaging manager and ensures compliance with GLP and ISO17025 standards in order to ensure maximum reliability in the results delivered to our customers. Manon leads the team advancing NASH associated imaging solutions to assist in the pathologist’s evaluation at Cerba Research. This development includes the evolution of digital pathology and software assisted analyses specific for NASH histological stains and their associated scores.

Pablo Ortiz, MD, PhD, Chief Scientific Officer, OWL Metabolomics

Pablo Ortiz became MD by Universidad Autónoma of Madrid (1972-1978) where he also achieved his PhD (1984-1990, Cum Laude) and Postgraduate with Honors in the Autonomous of Barcelona University about “Biostatistics in Medicine” (1980-1981). Pablo Ortiz graduated as an MD from Universidad Autónoma in Madrid (‘72-’78), after which he continued to a Postgraduate with Honors in Biostatistics in Medicine at the Barcelona University (‘80-’81). He also holds a PhD in Biostatistics in Medicine, obtained from Universidad Autónoma.
Pablo has extensive training in managing R&D projects and clinical trials, and over 25 years of experience (1979-2004) within the Medical Department of Boehringer Ingelheim. He was named Honorary Professor at the Faculty of Medicine of Málaga University in 2000 and from 2008 to 2011, and currently teaches in the Master’s in Biotechnology program at the University Pompeu Fabra of Barcelona.  From June 2004 until November 2012, he was CEO at Digna Biotech, a company created as a spin-off of University of Navarra, which he left with 4 clinical-Stage Products (1 small peptide, 2 proteins and 1 viral vector). He was member of the Board of Trustees in Fundación Moderna (Goverment of Navarra) and 2 Biotechs companies (Bionure and ProRetina) from 2010 to 2011. From January 2013 to date, Pablo is head of the Biotech division at Pivotal (Clinical CRO). He joined OWL in January 2013 as a senior consultant, in June 2014 as Chief Executive Officer and is currently its Chief Scientific Officer. He has published more than 30 papers in international peer-reviewed journals.

Nonnegotiable Central Laboratory Capabilities for I/O Clinical Trial Success

In immuno-oncology (I/O), meeting budget and timeline expectations in the journey from translational research to commercialization is a challenge. You need expert, integrated clinical laboratory and diagnostic solutions delivered by top scientists who will help you assess needs and generate early insights that optimize your protocol.

What else should you look for in a clinical laboratory partner? Along with access to a sizable patient database, impeccable performance across the globe, and I/O experience, three main testing capabilities are mandatory for success in this field: immunohistochemistry, flow cytometry, and next generation sequencing.