The new Vitro Diagnostic Regulation legislation comes into force on May 26, 2022. Diagnostic device manufacturers are working hard to ensure design, manufacturing, and post-market surveillance and vigilance of their products comply with the new regulations. As the clock ticks, few manufacturers are fully prepared: according to a survey conducted by MedTech Summit and NSF in early 2021, only 15% of respondent organizations were fully prepared to meet the IVDR deadline.

One of the main reasons for the delay was COVID-19. Almost all (95%) of respondents said the pandemic had impacted their IVDR implementation. While the European Commission recently proposed to adapt the full IVDR mandatory application dates depending on the class of medical device, organizations that are not already working with a Notified Body on CE mark submission may have a tough few years ahead. Download our whitepaper to find out more from Cerba Research.

More than three decades ago, scientists at the National Cancer Institute began exploring ways to fight cancer using the patient’s immune system. Their work formed the basis of what is now a promising cancer treatment that doesn’t require surgery or radiation. The global immunotherapy market as well as cell and gene therapy, such as CAR T, adoptive cell therapies, checkpoint inhibitors and other immunotherapies, is expected to grow by 10.1% CAGR between 2020 and 2028.

Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies. Each sample they give is precious, as they all provide a wealth of biological data that contributes to therapy development. To ensure samples arrive at the lab intact, robust sample transportation and global logistics are critical. The deep scientific expertise housed within those labs ensures the highest-quality analysis and reporting.

Our white paper takes an in-depth look at the world of flow cytometry. Nithianandan Selliah, Global Head of Flow Cytometry, and collaborators at Cerba Research, examine its unique benefits and future potential. They highlight the latest trends in technology and set out the key points to consider when planning a flow cytometry-based clinical trial and choosing a partner lab.

Discover our expertise in the field of Auto Immune diseases.

Investigations into autoimmunity benefit from a multifaceted approach.  

Genetic Testing/NGS

Along with infections and other exposures, genes play a significant role in disease development. Read more

Diagnosis & development

Tissue diagnosis and routine testing register pathology and the course of the disease

Immune monitoring

Gauge response to treatment by following up on the status of immune cells via flow cytometry

Biomarker Testing

Develop and follow serum markers for both diagnosis and prognosis of autoimmune diseases Read more