Ask the Experts: The Future of In Vitro Diagnostics
A number of key trends are fuelling the global in vitro diagnostics (IVD) market growth with increases of chronic and infectious diseases, and a rise in geriatric population is pushing towards more rapid tests at the bedside. In addition, advances in molecular diagnostics and personalized medicines are becoming increasingly linked to diagnostic testing, not to mention the need for speed as diagnostics are being pushed to deliver real-time results.
As specialists in the design and manufacture of in vitro diagnostic devices some of ITL’s brightest minds share their expertise in this Q&A about the current trends shaping the IVD industry.
What general trends are you noticing in in vitro diagnostic (IVD) technologies and the IVD industry as a whole?
ITL approach this from the point of view of a contract design agency, and whilst there may be alternative opinions depending on the market segment, ITL benefits from its breadth and longevity of experience when making these statements.
As a whole, the preference seems to be gravitating towards Point of Care (POC) diagnostics, mainly due to the advancement of technologies such as microfluidics, enabling developers to both miniaturise existing assays, but also develop new assays with a smaller footprint.
When ITL first began work in the field more than 40 years ago, most assays were being done in 96-well microplates, which by their very nature had a large footprint and required equally large processing stations.
Modern technology has seen assays move from this format, down onto single sample chips, and then gradually seems to be moving back towards multiplex assays, i.e. multiple tests being performed on a single sample to get the most “bang for your buck” from a single droplet of blood, serum, urine, etc.
This combined with new areas of focus such as next-generation sequencing (NGS), anti-microbial stewardship and a re-emergence of infectious diseases such as Ebola or Plague, plus the nature of caring for an ageing population is pushing towards more rapid tests at the bedside.
In which IVD application areas (molecular diagnostics, point-of-care, genome sequencing, etc.) are you noticing the most innovation and market potential, and why?
As mentioned earlier there’s a huge push from ITL’s point of view towards point-of-care (POC), and the combination of technologies into one platform in order to give a rapid answer. Oncology seems to be a great area of focus, potentially because of the ageing global population and the associated increase in the prevalence of various cancers.
How is innovative IVD technology supporting the trend toward personalized medicine?
At the moment, ITL feels that personalised medicine is still relatively contained to the laboratory. Whilst there a wide range of companies promising personalised medicine, the real-world use of that information is rather more limited.
Cancer diagnostics is an interesting field where this is seen – the sequencing of the genome of a tumour can be a useful tool, but cancer cells have the ability to mutate and change their genome quickly rendering a treatment ineffective. In this instance you have to revert back to more traditional treatment regimes.
Personalised medicine also brings up a host of other debates – namely around data – computer learning, probabilistic algorithms, etc are starting to generate interest, certainly from regulatory bodies such as the FDA who has produced guidance around multi-varied index analyses as a new class of IVD.
The task for now is all about speed – quickly obtaining an answer and prescribing the best course of treatment.
How do you expect IVD technology and the IVD market to transform in the years to come?
All of the above – patients are really starting to expect the benefits from all the investments seen over the years and the public news stories about technologies promising sci-fi levels of innovation within the next few years.
Biomarkers also seem to have the potential to play a big role moving forward – ELISA will probably still remain as a dominant force even if it is antiquated technology because it is fast, cheap and effective. The market moving forward will probably involve the handling of more data and more patient-specific data at that, which then brings with it the challenges of how you handle, store, and manage that information safely.
With 40 years’ experience as a contract manufacturer, our portfolio includes in-vitro diagnostics (IVD), point-of-care devices, cancer staging and treatment, surgical robots and next generation DNA sequencing.
In an ideal world, ITL brings the most to the table when a client is able to engage at a very early stage in their development lifecycle, right when the initial work is being done on cutting edge technologies, and to help bring them to the commercial market. This has happened previously throughout ITL’s history – the company was involved in its early days with the emergence of radioimmunoassays, and then through into ELISA and emerging DNA technologies through the 21st century.
This allows ITL to bring the best of both worlds – a great provenance in the development of instrumentation, combined with the ability to keep up with a breadth of modern technologies through the projects we engage with.
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