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Many key trends are fueling the global in-vitro diagnostics (IVD) market growth with increases of chronic and infectious diseases, and a rise in the geriatric population is pushing towards more rapid tests at the bedside. Also, advances in molecular diagnostics and personalized medicines are becoming increasingly linked to diagnostic testing, not to mention the need for speed for delivering real-time results.
At ITL, we are specialists in the design, development, and manufacturing of IVD devices. We rounded up some of our brightest minds to share their expertise in this Q&A and provide insight into the current trends shaping the IVD industry.
We approach this from the point of view of a design consultancy. While 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 diagnostic testing, mainly due to the advancement of technologies such as microfluidics, enabling developers to both miniaturize existing assays, but also develop new assays with a much smaller footprint.
When we first began working with IVDs over 40 years ago, most assays were 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. It then gradually seemed 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), antimicrobial resistance (AMR), and a re-emergence of infectious diseases such as Ebola or Plague, and now Coronavirus, plus the nature of caring for an aging population, has increased demand for rapid testing at the bedside.
As mentioned previously, there’s a huge push towards point-of-care testing and the combination of technologies into one platform in order to give a rapid diagnosis. Oncology also seems to be a prime focus, potentially because of the aging global population and the associated increase in the prevalence of various cancers.
At the moment, personalized medicine is still relatively contained in the laboratory. Whilst there a wide range of companies promising personalized medicine, the real-world use of that information is rather more limited.
We see this most in cancer diagnostics. The sequencing of the genome of a tumor can be useful, but cancer cells have the ability to mutate and change their genome quickly, rendering treatment ineffective. In this instance, you have to revert back to more traditional treatment regimes.
Personalized medicine also brings up a host of other debates – namely around data – machine learning, AI, 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.
All of the above. Nowadays, patients and customers expect a better standard of care after years of funding and public news stories about technologies promising sci-fi levels of innovation within the next few years.
Biomarkers 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 over 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.