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Cepheid Europe SAS

Cepheid

Cepheid is an automated molecular diagnostics innovator, focused on the speed and accuracy of PCR testing, enabling a higher quality of care, lower costs, and improved outcomes.

Lobbying Activity

Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics

5 Oct 2025

The principles of the IVDR (Regulation (EU) 2017/746 on in vitro diagnostic medical devices) are welcome, however implementation has fallen short in achieving its aims of a robust, transparent, predictable and sustainable regulatory framework for devices that ensures high levels of safety and supports innovation. As a global in vitro diagnostic (IVD) manufacturer, Cepheid support the proposal to revise IVDR, and believe that the initiative aims will be most effectively achieved through a combination of measures. Please see attachment for further details
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Meeting with Laurent Muschel (Acting Director-General Health Emergency Preparedness and Response Authority)

27 Nov 2024 · Pipeline & production facilities

Meeting with Ondřej Dostál (Member of the European Parliament) and Affordable Medicines Europe and RPP Group

15 Oct 2024 · Introduction

Meeting with Susana Solís Pérez (Member of the European Parliament)

27 Nov 2022 · AMR

Meeting with Dominique Riquet (Member of the European Parliament)

16 Nov 2022 · Santé

Response to Recommendation for strengthened actions against antimicrobial resistance

22 Mar 2022

Cepheid is a global automated molecular diagnostics innovator, focused on the speed and accuracy of testing delivered closer to the patient. Our mission is to deliver a better way to improve patient outcomes by enabling access to PCR testing everywhere. At Cepheid we provide a wide portfolio of diagnostic tests that can be leveraged in the fight against Antimicrobial Resistance (AMR) in both hospital and community settings and are expanding this portfolio with a number of innovative products. Our multi-use diagnostic platform works across more than 30 different CE-marked in vitro diagnostic tests, including multiple for detecting AMR-specific cases. In the hospital setting, Cepheid tests can identify the most common resistance genes that code for carbapenemase production in a time frame that allows targeted and effective infection control measures. Methicillin resistant Staphylococcus aureus (MRSA) carriage can be detected in about one hour, again allowing quick decision-making regarding isolation measures and initiation of suitable treatment. Outside of hospitals, detection of specific sexually transmitted infections enables focused treatment regimens, while the ability to identify Influenza A or B as well as Group A Streptococcus sore throats to prevent unnecessary antibiotic treatment can significantly benefit stewardship measures in primary care. Cepheid welcomes the Commission´s recognition for the need for greater action on AMR. As one of the main drivers of AMR is the improper usage of antibiotics, the rapid incorporation of testing to assess type of disease will play a significant role in reducing resistance, especially as it can be implemented relatively quickly. In vitro devices (IVD) are a much-needed tool for fast and accurate detection of patients colonized or infected with multidrug-resistant organisms to help prevent widespread outbreaks and determine the best infection prevention pathways. It is not only better for patient outcomes to be able to test rapidly and thus treat early, it is also more cost effective to reduce individuals’ hospital time, increase available beds and eliminate the use of unnecessary treatments. Through the COVID-19 pandemic, it has been demonstrated that there is high public demand and willingness to use fast diagnostics. Despite the many benefits, fast diagnostics have not yet been fully taken up by healthcare settings. Governments’ plans for post-COVID-19 recovery, specifically plans to reduce disease transmission and control outbreaks must consider positioning fast molecular testing at the heart of health systems. In many countries in Europe, access to fast automated diagnostics is still fragmented, and many patients need to wait days or even weeks for their results before being prescribed appropriate treatment. Cepheid calls on the Commission to address the barriers to fast diagnostic uptake by increasing education and awareness about fast PCR testing; create antibiotic control frameworks across healthcare systems to include antimicrobial resistance testing; financially support and incentivize the infrastructure for decentralization of testing outside of the laboratory settings; set high demands for the speed and accuracy of fast diagnostics; and ensure that relevant stakeholders, such as IVD manufacturers, are involved in the upcoming consultations. A clear, focused strategy to leverage molecular diagnostics together with guidance on targeted infection control and antibiotic stewardship measures, and ongoing surveillance, would allow Member States to develop and implement measures the most appropriate to their local health systems. Uptake of testing that can be integrated in various settings, such as emergency units, gynecological departments, hospital laboratories, and long-term care facility settings, to be able to test for multiple diseases, both relating to AMR and beyond, will ensure a more robust safeguard against any infectious disease outbreaks in the future.
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