In our last blog post, Andrew covered how immuno-oncology is driving the development and utilization of digital pathology and multiplex spatial tissue analysis. In his blog, Andrew included all plex levels, but for this blog post we will be focusing on technologies capable of 20+ plex. While digital pathology has been on the market for some time, highly-multiplexed tissue imaging is a fairly recent development. Until March of this year, only a single platform was available: Fluidigm’s Hyperion Imaging System.

On May 2, Fluidigm reported Q1 2019 revenues of ~$30M, a 19% year-over-year increase. During this quarter, Fluidigm’s mass cytometry segment experienced an impressive 110% year-over-year increase in revenues to $18.8M. Vikram Jog, CFO & Principal Accounting Officer, highlighted strong sales for both the Helios and Hyperion systems as major contributors to this growth. The Hyperion was the first highly-multiplexed tissue imaging system to hit the market and was named the “No. 1 Innovation of 2017” by The Analytical Scientist. The Hyperion is an imaging mass cytometry (IMC) instrument and enables researchers to simultaneously image up to 100 different markers (a 37-plex panel is commercially available), a substantial advancement over the single-to-low plex capabilities of H&E (hematoxylin and eosin, a basic histology stain), immunohistochemistry (IHC), and immunofluorescence (IF). This increase has only been made available to a limited number of researchers with access to these instruments, but highly-multiplexed tissue imaging has already been shown to be a useful tool and it will emerge as a critical research and clinical tool in the future, as assessed by many KOLs we interacted with at AGBT and AACR.

As covered by our previous life sciences market research blog posts, immuno-oncology has been one of the primary drivers of multiplex technology development. Nanostring’s recently-launched GeoMx Digital Spatial Pathology (DSP) instrument has already generated a substantial amount of data despite an as of yet relatively small install base and will certainly be at the center of attention at ASCO 2019. Three of the ten abstracts highlighted by Andrew last week utilized Nanostring’s GeoMx (abstracts 3142, e20071, and e14218). Two of these concluded that highly-multiplexed tissue imaging technology is able to provide better insights, identify unique targets, and possibly help lead to improved patient outcomes when compared to standard practices, as mentioned by Chumsri et al. The third abstract is from an ongoing study. Despite being limited to academic research for the foreseeable future, highly-multiplexed tissue imaging technologies will be used clinically. While this is far off, the implications of utilizing this technology have become apparent. As artificial intelligence (AI) and machine learning (ML) capabilities increase, and as multiplex technology improves, these systems could be used to easily stratify cancer patients to the best immunotherapy options. While this avalanche of data is currently difficult to work with, AI and ML improvements will aid in analysis.

Edit: The original version of this article stated Dr. Garry Nolan as the inventor of the CyTOF instrument. This is not the case, and it has been corrected. DVS Sciences is the company which created the CyTOF instrument and Nolan was heavily involved in the development of CyTOF applications for the immunome.

As mentioned earlier, the Fluidigm Hyperion Imaging System is no longer the only highly-multiplexed tissue imaging platform available. Just last month Akyoa Biosciences, NanoString, and Miltenyi Biotec announced their offerings: the CODEX, GeoMx DSP, and MACSima, respectively. In addition to these three recent additions, IONpath, ReadCoor, and 10X Genomics are poised to enter the market in the near future. Each of the technologies is outlined above.

Of these technologies, the MIBI platform commercialized by IONpath is the most similar to Fluidigm’s Hyperion and will be a direct competitor to the platform. The use of an ion beam may lead to a few improved capabilities over the Hyperion’s laser-based system. While there are a number of competitors poised to enter the market, Fluidigm will be closely watched by industry experts and potential buyers, particularly when the MIBIscope I is launched by IONpath because of the two platforms’ similarities. Until then, though, Fluidigm is already facing stiff competition from Nanostring. The GeoMx platform generated a lot of excitement during the technology access program before its official launch last month, and Nanostring was able to secure more than 30 pre-orders for the instrument in 2018--almost a full year before the first deliveries were expected. Consumers will soon have a wide variety of options to choose from to meet their multiplex imaging needs in this exploding market, and our life science market research experts believe there is enough demand for multiple technologies to coexist in the market. With the GeoMx’s strong pre-order performance, Nanostring seems poised for success in the near-term, but IONpath’s MIBIscope I could pose serious challenges to both Nanostring and Fluidigm’s multiplex imaging offerings in the long run.

DeciBio will be at ASCO2019! Check out our ASCO2019 Conference Analytics Tool. To learn more about the immuno-oncology biomarkers driving the development of highly-multiplexed tissue imaging technologies, check out our I/O BioMAP.

Author | Max Jorgensen

Max is an Analyst at DeciBio with a background in neuroscience and data analysis. At DeciBio, the projects Max has been involved with have been spread across life science research tools, diagnostics, and our data products. Connect with him on LinkedIn.

PMC search terms for multiplex IHC / IF: multiplex AND (immunohistochemistry OR ihc OR immunofluorescence)
PMC search terms for 1-plex IHC / IF: (immunohistochemistry OR ihc OR immunofluorescence) NOT multiplex
PMC search terms for highly-multiplexed: (akoya AND codex) OR "co-detection by indexing" OR "codetection by indexing" OR cycif OR "t-cycif" OR (nanostring AND dsp) OR "digital spatial profiling" OR (nanostring AND geomx) OR (geomx AND dsp) OR fisseq OR "fluorescent in situ sequencing" OR readcoor OR "imaging mass cytometry" OR (fluidigm AND imc) OR (fluidigm AND hyperion) OR macsima OR (ionpath AND mibi) OR "multiplex ion beam imaging" OR mibiscope OR "spatial transcriptomics"