Finally, Another Notified Body Announced.


Istituto Superiore di Sanita, based in Rome was announced as the 13th Notified Body (NB) in September, nearly a year after the previous new addition. ISS is the first NB in Italy. There are now 4 in Germany, 2 each in Finland and The Netherlands, and 1 each in Austria, France, Italy, Ireland and Slovakia. The low numbers of NB still represent a significant potential road block to the full implementation of IVDR yet, ironically, there are now reports that these NB may have spare capacity as manufacturers delay their applications in order to pursue regulatory submissions in other jurisdictions or wait to see what happens as a result of the extension to full implementation.


The European Commission has further extended the deadlines for full implementation of IVDR.As with the previous extension, the new one will be staggered according to device classification meaning implementation for Class A and B devices won’t occur until the end of the decade. 

EUDAMED: Mandatory Registration, At Least for Those Bits That Work

According to the European Commission: “EUDAMED is the IT system established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. EUDAMED is integral part of the implementation of the two Medical Devices Regulations.” It is structured around 6 modules and a public website but currently only 3 modules are available with the rest varying times away from deployment. The Commission has decided that IVD manufacturers will need to begin registration with those modules of EUDAMED that are deployed from Jan 2026 instead of waiting for the entire system to become available. Industry bodies have expressed concerns that manufacturers are not devoting sufficient resources to training users and preparing documentation for inclusion in EUDAMED and advise them to address registration on the system as soon as possible.
Included in mandatory notifications for manufacturers is a requirement for them to notify the EU or their Competent Authorities if an IVD is at risk of becoming unavailable.

Despite Progress and Extended Deadlines, There’s Still Concerns

Various groups have been expressing concerns about the slow implementation speed and complexity of both the MDR and IVDR.
A group of 29 national associations and the EU-wide industry association MedTech Europe sent an open letter to the Commission, via its outgoing Commissioner for Health & Food Safety, requesting action to ensure device availability and competitiveness. They also had this to say about the two regulations:
“The unpredictability, complexity, and burden of the regulations means that many devices on the market today as well as new, innovative medical technologies are not reaching patients in Europe as they should. The competitiveness of the wider industry and even the viability of many small businesses (SMEs) are at risk.”

They pointed out that the incoming regulatory process is complex, slow and overly bureaucratic, hampering companies who are trying to bring new products to market. This limits innovation and availability of cutting-edge products to EU patients, while reducing their competitiveness.

The industry associations also called for a series of bridging measures to “…halt the continued disappearance of devices from the EU market and for attracting investment in bringing innovations to Europe”

Industry isn’t the only group with concerns. Members of the European Parliament (MEPs) have also expressed their concerns about the medical device and IVD regulations. According one MEP, the EU “…has introduced "loads of rules" that do not increase safety, but cause expense and effort to rise and that costs us jobs and economic growth at a time when the European economy is in a crisis situation”, creating a “bureaucratic monster” in the process. The EU parliament called on the incoming Health Commissioner to “step up” the implementation of the current regulations and evaluate the need for potential changes otherwise MEPs agreed, MEPs agreed, Europe's (EU) competitiveness will further decline, industry will pay and patients will suffer further shortfalls in care.

After different delays and not without concerns, the implementation of IVDR, the new regulatory framework for in-vitro diagnostic in the EU, has now started. Molecular testing in oncology is likely to be one of the areas in which this legislation will have a bigger impact, with questions and concerns having been raised by all the stakeholders involved in biomarker testing. However, IVDR is here to stay, and laboratories are facing a transition period in which they will need to adapt to this new reality.

 Ovarian Cancer: The importance of testing for genomic instability in addition to BRCA1/2 mutations in aOC

Dr. Vail is the director of the clinical molecular pathology laboratory at Cedars-Sinai Medical Center. The laboratory has a full suite of molecular diagnostic assays, encompassing viral, genetic and oncology testing. Dr. Vail’s academic focus is on the effective utilization of genomic biomarkers, especially those provided by NGS, in the clinical setting and provider outreach and education.

In this session, Dr. Eric Vail discusses the importance of genomic instability testing in advanced ovarian cancer patients. The session covers the clinical guidelines and recommendations for BRCA1/2 mutation testing and HRD status assessment through comprehensive genomic instability testing in ovarian cancer patients and its role in informing the use of PARPi therapy.

The reasoning for this situation is complex and multifactorial some of the causes are related to the following:

Lack of awareness of the new biomarker/test

Lack of proper training/optimization in running the test in the lab

Laboratories considering the adoption of a new biomarker test must assess its clinical utility, cost-effectiveness, and impact on patient care in comparison to existing diagnostic methods.

Additionally, they may need to provide training for laboratory staff and ensure seamless integration of the test into current laboratory information systems.

Developing a validated companion diagnostic (CDx) test aimed at identifying suitable patients for precision medicine (PM) treatment does not automatically guarantee precise detection of the appropriate patient population and subsequent delivery of treatment. In the current landscape of clinical diagnostic testing, many patients do not receive necessary tests in a timely manner, despite their availability.

Even after obtaining regulatory approval and completing technical optimization, the commercial availability of a biomarker test does not guarantee immediate uptake in laboratories. Factors such as reimbursement policies, clinician awareness and acceptance, and the availability of supporting infrastructure and resources can influence the pace of adoption.

This delay in accessing tests, and consequently treatments, is attributed to the inadequacies of the current clinical diagnostic testing landscape. This unprepared environment poses numerous challenges to the clinical implementation of CDx tests, hindering their diffusion and utilization.

To delve deeper into how data-driven engagement can address these challenges and facilitate the adoption of new biomarker tests, we invite you to join our upcoming webinar on November 13th from 1-2 PM EST: 

Optimize Your Physician Engagement Strategy: Data-Driven HCP Education in Precision Medicine

This session will focus on effective strategies for leveraging data and omnichannel approaches to enhance physician engagement and lab education. By rapidly identifying and educating healthcare professionals about your precision medicine therapies, we can ensure timely awareness and understanding, ultimately driving adoption rates and improving patient access to essential testing and treatment


Register here 

The uptake of a new biomarker test takes too long.

Artificial Intelligence in Prostate Cancer: from clinic to lab 

We are delighted to welcome our guest speakers; Pr. Sophie Ferlicot, Head of the Department of Pathology of Bicêtre Hospital, AP-HP, Paris-Saclay University, and Dr. Mario Terlizzi, a radiation oncologist and brachytherapist at the Gustave Roussy Institute for our sixth episode of the 'Better Testing, Better Treatment' podcast series. 

Prof. Sopie Ferlicot and Dr. Mario Terlizzi explore the applications of AI in prostate cancer care, including diagnostics (imaging and histological assessment), and therapeutics. 

Don't forget to catch up on previous episodes!

Listen now

We are excited to announce that our sixth episode is available now.

This delay in accessing tests, and consequently treatments, can be attributed to the unpreparedness of the clinical diagnostic testing landscape into which these tests are introduced. Such a setting presents numerous challenges to the widespread implementation of CDx tests, hindering their diffusion and adoption.

Awareness among physicians regarding biomarker tests is crucial, as they initiate the testing process by ordering these tests. The slow uptake of tests that follows is often due to a lack of awareness regarding the clinical utility of new biomarkers and associated therapies.

The availability of testing is paramount for adoption, but equally important is the availability of tests in laboratories that physicians trust and prefer. Hence, raising awareness among laboratories is crucial for facilitating the offering of tests.

By investing in pre-launch planning and CDx tests, the clinical diagnostic testing landscape can be positively impacted. Strategic preparation ensures that early adopters are informed about 'how and where to request testing' and understand how to interpret the results. This, in turn, benefits biopharmaceutical companies by increasing the return on investment (ROI) through improved access to testing and treatment for more patients.

To explore more about how data-driven physician engagement can enhance the adoption of precision medicine, join our latest webinar, 

‘Cutting Through the Noise: Data-Driven Physician Engagement in Precision Medicine’ on November 13th, 1-2 pm EST.

Join Gosia Leitch, VP of Engagement Solutions at Diaceutics to explore how data driven omnichannel strategies can enhance engagement by precisely targeting physicians treating patients with relevant biomarkers. Discover how leveraging laboratory data can accelerate the adoption of novel treatments, enabling rapid engagement with physicians within 24 hours after a patient tests positive for a relevant biomarker.

Register for the webinar

In the field of oncology alone, inefficiencies stemming from inadequate market development planning for companion diagnostic (CDx) tests currently result in 50% of patients not receiving appropriate testing for biomarker-guided treatment.

Insights

IVDR Report Update 2024

Ovarian Cancer: The importance of testing for genomic instability in addition to BRCA1/2 mutations in aOC

Overcome the challenges of Implementing New Biomarker Tests in Labs

Artificial Intelligence in Prostate Cancer: from clinic to lab

Early awareness campaigns obtain better results