Driving innovation in diagnostics
As we closed out 2024 with an eye on the exciting challenges lying ahead for our sector in 2025, our Communications Team took a moment to chat with Hamid Erfanian, Vice President and General Manager of The Binding Site, part of Thermo Fisher Scientific.
Hamid has spent his entire career serving the scientific industry, applying his technical experience to various commercial roles across a number of specialities, from oncology to haematology. Here, he shares his insights into the ever-shifting diagnostics sector, showcasing how Thermo Fisher maintains its market-leading position through innovation and keeping the patient at the heart of the company’s ethos.
The clinical diagnostics industry has been booming in recent years. What is driving this momentum? And how is Thermo Fisher contributing?
The diagnostics industry has long suffered from a shrinking workforce, which places enormous pressure on labs. Many are simultaneously experiencing an increase in demand, compelling them to look for automated solutions to fill the labour shortage gap and maximise their resources. We’ve looked to address this need through the launch of innovative technology such as our EXENT® System for the assessment of monoclonal gammopathies (MGs), which uses MALDI-TOF mass spectrometry. Traditionally, the diagnosis and monitoring of MGs – most notably, multiple myeloma (MM) – has largely relied on the detection of M-proteins with serum protein electrophoresis (SPE) and immunofixation electrophoresis (IFE). Although reasonably sensitive, these dated methods require a lot of manual work from skilled personnel, which a lot of labs are simply struggling to find. We’ve replaced complex analysis with a fully automated workflow that delivers computer-generated, quantifiable results that are not subject to user interpretation errors, helping to diagnose and monitor patients more accurately. This is just one example, but we – the industry – will continue to evolve, addressing the shortage in the labour force, improving accuracy and precision and, ultimately, helping clinicians to care for their patients.
You touched on ‘complex’ technologies, which is interesting, as there are still many somewhat outdated methods regarded as gold standards in diagnostics. How much do companies such as Thermo Fisher help to ensure new solutions reach the patients they are designed to help?
When any new technology is developed, I think the company plays a key role in ensuring regulatory bodies and clinicians fully understand its potential in the patient care pathway. I’ll use the example of MM diagnostics again. In the early 2000s, we introduced the Freelite® assays to the market, which quantify free kappa (κ) and lambda (λ) light chains in serum and allows calculation of the κ/λ sFLC ratio. Shortly afterwards, the International Myeloma Working Group (IMWG) – a respected organisation among myeloma researchers – incorporated free light chain assays into guidelines for diagnosing and monitoring plasma cell disorders. We worked very hard with the IMWG for this due to the identified clinical need and recognised benefits of the technology to the patient. We have since taken the role to drive innovation and evolution in this field. To this end, we continue to have a close working relationship with the IMWG and leaders in the field around the world, listening to the challenges and needs in the clinical space. This ensures that our direction isn’t driven by what the market demands, but rather by what the patient needs.
How important is it to keep the patient and clinician at the fore when designing diagnostics assays and equipment, even though it is the lab that uses them?
As you say, our day-to-day business revolves around serving the labs. They are our partners and the end users of our technologies, and they, along with patients, are the reason why we do what we do. We therefore listen to them on how we can improve workflows and help them become more productive; they want products that provide them with the best quality, most efficient workflow - and if possible, more economical - so that’s what we strive for. But these same labs are ultimately serving the clinicians out there – who look after patients – meaning we also need to keep an eye on what’s happening in the clinical space. In fact, labs will often follow the clinician’s lead – as well as guidelines and regulations, of course – but, sometimes, we’ve found that we need to facilitate these discussions to ensure that both parties are aware of the latest available innovations. Ultimately, our goals are aligned with clinical diagnostics organizations in providing outstanding patient care possible through providing high quality that enable their workflow efficiency.
Pivoting back to multiple myeloma, what are the hot topics right now, and do these differ in different regions?
To a certain extent, the industry is focussing on how we can diagnose patients earlier and monitor treatment to achieve better outcomes, as well as developing the tools that can achieve this. Evaluation of monoclonal gammopathies of unknown significance (MGUS) – a non-cancerous condition that increases the risk of developing MM – is central to this and has come a long way in recent times. There’s also a push to ensure that primary care clinicians are fully aware of the early signs and symptoms of MM, and that they are up to speed with the current guidelines. We try to help this by developing non-branded educational materials to educate primary care clinicians. Clinicians and laboratories have embraced this initiative, and we’ve actually seen an increase in patient testing and, consequently, more cases of MM diagnosed early. This is a really rewarding part of our job, knowing that we are contributing to the early diagnosis of some patients, which can significantly improve their outcomes.
Finally, what is happening among your competitors? And how do you think Thermo Fisher can hold its leading position?
As long as we stay true to the science and the patient, we are confident that we will keep innovating and improving patients’ lives. This stems from the enormous talent we have here at Thermo Fisher. I recently participated in an extended leadership call, scrolling through hundreds of faces radiating enthusiasm and ambition, while listening to the wealth of diverse and profound experiences they brought to the table. I have had the good fortune of joining a company that is a leader in the field of specialty diagnostics, and it was clear from this call that it is in capable hands. Going into 2025, we’ll need to continue our intense focus on innovation and ingenuity for the benefit of our customers and the patients they serve; relying on our diverse and talented workforce.
© 2024 kdm communications limited
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EXENT, EXENT-iP500, EXENT-iX500, EXENT-iQ, and Freelite are registered trademarks of The Binding Site Group Limited (Birmingham, UK) in certain countries.
The EXENT® System combines EXENT® Analyser with Immunoglobulin Isotypes (GAM) for the EXENT® Analyser. Product availability is subject to country specific regulatory requirements. Please contact your local Binding Site representative for availability in your country. The EXENT is not commercially available in the USA or China. Future commercial availability cannot be guaranteed.