PN: Let’s begin by introducing our readers to IVD. What is it and where would someone encounter IVD in their daily life?

HD: I should start by clarifying what in vitro means. In a survey we conducted, we discovered that many people believe that the in vitro in IVD is related to in vitro fertilization (IVF). Now, in vitro in IVD is Latin for “within the glass”. Think of the times you’ve seen scientists use glassware to do experiments in the lab. We call those experiments in vitro because they are done outside a living organism. However, the in vitro in IVF differs from the in vitro in IVD. In IVF, we fertilize an egg with sperm outside the body. Conversely, when we say in vitro diagnostics, we refer to tests that we do on biological samples to see how healthy a person is.

We can test a wide range of samples, such as blood, urine, saliva, and even tissues to assess a person’s health. From those samples, we would measure the concentration or presence of different molecules that can tell us various things. IVDs can tell us how well a medical treatment works, how severe a person’s disease is, and if a person will experience side effects from a drug.  For treatments such as chemotherapy, this last is important – as the use of diagnostics can stop people from having an ineffective treatment which may have debilitating side effects.

People have already used IVDs throughout their whole lives. Whenever you conduct a blood test, you use an IVD. When you measure haemoglobin A1C (HbA1c) levels to monitor your diabetes, you use an IVD. When you take a pregnancy test, you’re also using an IVD. Many of these tests, like the pregnancy test, can be done within the community. However, healthcare workers also commonly perform these tests. When the COVID-19 pandemic began, care practitioners collected nasal swabs and measured SARS-CoV-2 gene copies with qPCR. Then, companies developed lateral flow devices so the public could test themselves for SARS-CoV-2 at home.

PN: You’ve touched upon a lot of ways that IVDs can be used in the clinic, highlighting their usefulness in medical care. I imagine that trade associations like BIVDA would be vital for advancing novel IVDs in the clinic. But what is BIVDA? What is their mission, and how do they fulfill their mission?

HD: Yes, two years ago, we celebrated the 30^th anniversary of BIVDA. BIVDA stands for the British in vitro Diagnostics Association. We are a trade organisation that represents a growing network of stakeholder members from over 200 companies. The companies within our network design, produce, and distribute IVD products and services for their customers. BIVDA works to foster closer relationships with policymakers and decision-makers to demonstrate how IVDs can make a difference in patients’ lives. Our intricate network provides us with the expertise, skill, and experience to advance patient care.

It’s not just our network that helps BIVDA advance IVDs in the UK. As an organization, we fulfill our mission by focusing on four key areas. They are as follows:

• Research: Our work aims to inspire and support the next generation of researchers, scientists, and companies to develop and deliver IVD tests.
• Advocacy: We believe that a test result should mean just as much as a drug in a patient’s hands. As such, we influence key players throughout the system to encourage the use of IVDs appropriately to ensure that any treatment will work best for them.
• Lobbying: We collaborate with policymakers, the National Health Service (NHS), regulators, and other stakeholders to ensure that innovation in the system and innovative diagnostics are delivered to patients quickly and effectively.
• Investment: We work with funding sources ranging from the UK government to venture capitalists to ensure strong financial support for companies developing and selling novel IVD tests. This includes grants and international investments that bolster the UK economy.

PN: It’s clear that BIVDA is a well-established player in IVD with its ever-growing network of stakeholders. I imagine that each of these companies faces various challenges in making novel IVDs available to the public. What are the most common challenges you’ve seen?

HD: The biggest we’ve seen, irrespective of the field, is navigating the regulations in place for IVDs and making the UK more attractive for investment. The NHS wants to ensure safety and accuracy for all IVDs. However, because of how the NHS is funded, sales into the NHS are low-profit. They also have stringent regulations and processes that increase the cost of product development. This is a perfect storm that causes delays in the return on investment for IVD companies and makes it harder to deliver new products.

That’s not to mention the various problems we’ve seen when implementing IVDs for various diseases. For one, we face challenges in scaling up AMR diagnostics for patients in the UK. We have the expertise, development, and appetite from our stakeholders to fight AMR with robust diagnostic tools. However, we in the UK struggle to adopt these technologies at country-scale level because of funding complexities and a focus on short-term, not long-term problems.

We’re also seeing similar issues in other disciplines. For one, rare diseases are difficult to invest in because they, by nature, are rare. That makes adopting new IVDs for detecting rare diseases difficult. Adopting sequencing-based efforts to diagnose disease is also difficult due in part to the high cost of preparing nucleic acids for sequencing and identifying gene variants. Ultimately, we don’t just want to be an ideas factory. We want our ideas to become tools that we can use to fight diseases much more effectively.

PN: The challenges to bringing IVDs into the UK seem daunting, requiring a large organization like BIVDA to address them. How has BIVDA worked towards addressing these challenges?

HD: We are dedicated to improving access to IVDs for patients and the public. We demonstrate to policymakers across the system the value of creating the most appropriate regulatory and market access regimes. This will speed up access to technology, innovation, and funding for patients and providers. We also help companies, big and small, navigate and understand the landscape and resources needed to partake in the UK’s IVD sector. Lastly, we promote the value of IVDs by using the evidence available and developing more to create a market for diagnostics.   

PN: Thank you for sharing the important work you do at BIVDA. I admire your hard work in getting IVDs off the ground in the UK. To end the interview, what can LBS 2024 attendees expect to learn from your speech?

HD: My current talk will cover in greater detail some of the material that I covered in this interview. Through my talk, I aim for our attendees to appreciate the work needed to bring novel IVDs into the UK market. Attendees from other markets can also learn from our experiences. Through my talk, they can learn how they can navigate their markets’ regulatory environments to facilitate IVD uptake. Lastly, I want to demonstrate that BIVDA plays a key role in fighting various acute issues that we face, from the current NHS backlog to precision medicine. Through LBS 2024, I expect that I, along with many of my fellow speakers, will play a big part in making the conference a success for advancing biomedical innovation.