Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Point of Care Diagnostics

Larry H. Bernstein, MD, FCAP, Curator

LPBI

Point-of-Care Diagnostics—An Expanding Field Driven by Technology Development 

Impact of Various Disease Classes on the Development of POC Diagnostics

Gary Oosta, Ph.D., Enal Razvi, Ph.D.

Figure 1. POC diagnostics word cloud

• There is growing interest in the point-of-care (POC) diagnostics field as the space is expanding and evolving from pure technology development to applications development in various settings. We sought to understand the dynamics of the point-of-care diagnostics field by examining the entire ensemble of publications in this space and analyzing trends from the bottom-up.

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  Figure 2. POC diagnostics is a global field.

  We harvested and analyzed 14,046 publications from the academic literature where the search terms were “point-of-care” in the titles and/or abstracts of the publications.  Figure 1 presents a word cloud that shows a pictorial representation of the abundance of various terms within this space as a means to illustrate the dataset which we harvested.  Most of the data was collected in 2015 and therefore it represents the current scenario of the field.

  We subsequently sought to understand the nature of the POC diagnostics field by examining the geographic source of these publications—is this a concentrated marketplace or is it truly global in nature, vis-à-vis research and publications in this field.  Figure 2 presents the geographic breakout and this clearly shows that POC diagnostics is a global field.

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  Figure 3. Growth of publications in the POC diagnostics space.

  The U.S. dominates publications in this space with 39% of total but it’s important to note the breakout is truly global in nature and attests to the fragmented nature of research in this field.

  We also sought to understand the pace of growth of this field—if the hypothesis is that the POC diagnostics field is expanding we should observe a steep climb in the growth of publications—Figure 3 presents this data, which shows a clear expanding space and this begs the question as to where the growth in the field is coming from. To address this question, we examined the compound annual growth rates (CAGRs) of the various segments of the broader POC diagnostics space and this data (not presented in this article) suggest that specific segments of the POC space are outperforming the growth of the broader POC diagnostics space and there are opportunities for applications development in these particular spaces.

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  Figure 4. Cardiovascular disease classes are an important component of the POC space.

  Infectious diseases are a strong theme in the overall POC diagnostics field and estimates suggest that infectious diseases account for 70% of the overall POC diagnostics marketplace.  Our industry research however also suggests that the oncology space is experiencing growth in the POC diagnostics arena and this suggests to us that the technology development taking place in POC diagnostics is starting to branch out and impact other market segments.  Another space we investigated as part of our industry analyses was the impact of POC diagnostics into the cardiovascular diseases space.  Figure 4 presents the publications landscape of POC diagnostics impacting various cardiovascular disease classes.

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  Figure 5. In POC, specific biomarkers are an almost unexplored space.

  Even though POC diagnostics seeks to interrogate biological marker[s], the specific biomarker[s] that are implicated in POC diagnostics are generally not well characterized and indeed studies of biomarkers do not crossover into POC diagnostics.  We interpret this data to mean that the majority of the efforts in the POC diagnostics field are focused on technology development, approaches for deployment into the point-of-need setting rather than the molecular characterization of the biomarkers that are the underlying molecular entities associating the readout with the biological phenotype studied. This is especially true in the cancer biomarkers space where there is an extensive body of literature where specific biomarkers or signatures thereof are associated either as prognostic or diagnostic biomarkers with specific pathological states—such levels of association are not observed in the POC diagnostics field.  This will evolve over time and such molecular associations of the lesions will be described.  Figure 5 presents the publications landscape of specific biomarkers that have been described thus far in the POC diagnostics space.

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  Figure 6a. In the POC space, the penetrance of cancer is growing, albeit small currently.

  POC diagnostics are suited ideally for high-impact diseases for which quick time to diagnosis and treatments are crucial, cardiovascular diseases for example as well as infectious disease where time to diagnosis is a key determinant of the therapeutic regimen that is deployed.  The broader cancer space impact on POC diagnostics is small at the present time, but growing.  We believe that the impact of minimally invasive diagnostics such as biofluid/liquid biopsies will increase the penetrance and impact of POC diagnostics into the cancer diagnostics space.

  The impact of molecular diagnostics tools onto the POC diagnostics space is expanding, and we believe that this trend will drive the interrogation of specific molecular species [biomarkers] in the POC context.  In this vein, we have noted that the penetrance of PCR amplification in POC diagnostics is growing suggesting the potential move of molecular testing, MDx, precision medicine into the POC diagnostics space.  We will continue to monitor this trend closely as the impact of nucleic acid analyses into POC diagnostics is an important theme and will enable precision medicine at the molecular level in the point-of-need setting.

  Earlier in this article, we alluded to the observation that in the point-of-care diagnostics setting cancer is currently a small contributor but is a growing space—Figure 6a illustrates this trend.

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  Figure 6b. Segmentation of cancer classes by penetrance by POC diagnostics.

  We have further characterized this market segment and found that specific cancers are represented to various degrees—breast cancer is the most penetrant.  Figure 6bbreaks-down the various cancer classes vis-à-vis their penetrance into the POC diagnostics space and the trends observed are very interesting as they reflect on clinical practices in cancer screening as well as early diagnostics testing.  We seek to analyze this trend over the coming year to observe shifts in cancer POC diagnostics with the mounting interest in the liquid biopsy space—liquid biopsy can be viewed as a POC diagnostic since it is minimally invasive and can be performed in out-patient settings—a hallmark of the POC diagnostics space.

• In summary, we have framed the current landscape of POC diagnostics, seeking to bring together various disease classes and describing their impact on the overall POC diagnostics field.  We continue to monitor this space as it evolves and is impacted by other fields, such as liquid biopsies, which will affect the character and dynamics of this space. We believe that not only will new technologies (such as microfluidics) drive the POC diagnostics field forward in resource-rich and resource-limited settings but also the impact of new biomarkers and biomarker classes will drive the field forward as more precise tailored-medicine becomes the norm in clinical practice.  Therefore even though currently POC diagnostics is deployed for high-impact diseases, the trend is moving toward its utilization in many niches of clinical unmet need.

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  At the 2nd Annual Biofluid Biopsies and High Value Diagnostics 2015 conference Select Biosciences brings together academic researchers, industry researchers, as well as biotechnology and pharmaceutical companies to explore the expanding and evolving field whereby Circulating Biomarkers of various classes are being evaluated for their potential to be developed into diagnostics for cancer as well as other disease classes.