Safe and accurate In Vitro Diagnostics (IVDs) are essential to a safe, efficient and effective healthcare system. Policymakers recognise this and that’s why they have included a clinical evidence requirement in the upcoming revision of the IVD Directive (IVDD). Because IVDs play such a pivotal role in the treatment pathway of patients, we, the IVD industry, fully agree with the need for adequate data on safety and accuracy of our products. But we need to make sure the requirements are tailored to the specificities of our industry.

Clinical evidence what?

Don’t worry if clinical evidence requirements do not immediately ring any diagnostic bells with you. They’re not often front page news on the FT. And when thinking about evidence requirements for medical technologies, one easily thinks of medical device requirements which assess whether the therapeutic effects of a device are indeed what they claim to be and what its impact is on the patient’s well-being.

When it comes to IVDs, it’s a whole different game, first and foremost because in this case we’re not ‘treating patients’. What IVD manufacturers have to demonstrate are 3 things: scientific validity, analytical performance and clinical performance.

Scientific validity basically is about answering the question: what is the meaning of the result you can read off of a test? Or in real terms: what is the meaning of high glucose in a diabetic patient (insulin may be needed to control it). While for established assays the scientific validity is well-known, for new diagnostic tests such as novel genetic tests or companion diagnostics, this is not the case, and the scientific validity of these assays will have to be determined before they can be made available for widespread use.

Analytical performance needs to demonstrate whether an IVD can accurately measure what it is supposed to measure time and time again. Will a given test operate in the same way under different conditions? What about day versus night, or different days of the week?

In terms of clinical performance, what we need to show is how the diagnostic test performs in a real, day-to-day environment. Does the test work well with other medical equipment, other instruments? Does it work in the setting where it is meant to be used? Will it work on different patients such as children or pregnant women, and if so which are the normal values for them?

While all this data gathering and research creates considerable overhead for the in vitro diagnostics industry, we unanimously feel that these requirements truly increase safety, efficiency and effectiveness, and reach the objective they were created for.

So what(‘s in it for me)?

Accurate diagnostics benefit everyone: patients, healthcare professionals and of course healthcare systems at large. And providing clinical evidence for IVDs is one way of ensuring this. Healthcare systems benefit from this, for instance thanks to more efficient healthcare delivery or less instances of costly, adverse events, while HCPs can count on diagnostics to guide them in their decision-making process and in choosing the optimal treatment pathway for each patient. But also for patients themselves, quick and accurate readings are of immense value. Women find out within a few minutes and with 99% accuracy whether they are pregnant, regardless of the time of day, their physical condition, whether they smoke or not, and so on. Why? Because all these parameters have been researched.

In the same vein, women can reliably be screened for cervical cancer, tested for toxoplasmosis or pre-eclampsia using a quick and reliable diagnostic test. IVDs are not only something that lab people in white coats use in their laboratories… they are a fundamental part of everyone’s life. This evolution was made possible thanks to the quick and accurate results they provide. In fact, we’ve gotten so accustomed to measuring our blood-glucose, testing when our wives are ovulating or being able to rule out Down syndrome in foetuses with a great level of accuracy that it’s become unimaginable not being able to do so any longer. This is a risk for future diagnostic technologies if the new regulatory framework for IVDs, when setting out the data requirements, does not take into account the limitations and specific nature of diagnostics. Failing to do so would not only have a considerable impact on an important industry in Europe which guides 80% of medical decisions, but would also take away essential new tools for HCPS and leave patients with no access to the information they value so much.

Serge

– Serge Bernasconi, Chief Executive Officer, EDMA