“Unlocking your Ingenuity” was the brilliantly appointed theme for the 2019 USCAP Annual Meeting that seemed to reverberate off the walls of the Gaylord Convention Center in Maryland in March.

It occurred to me that this Tony Robbins-esque theme could be applied to the field of personalized medicine as a whole.   The direct patient focus by USCAP to empower Pathologists, Histotechs, and clinicians through products to guide decision-making is palpable and continues to reinforce the message that tissue testing remains critical to personalizing patient care along the entire tissue journey.

It’s a Great Time to be a Pathologist

We are now neck-high in the digital age so it’s no surprise that innovative digital imaging tools and educational programs are popping up left and right to support the complex decisions required for interpretation by Pathologists.

• Web-based eLearning programs are now available to train Pathologists from the comfort of their office – providing everything from interpretation support to digital case collaboration and review.
• There is an increased focus on honing the skills of Pathologists to allow them to do more both on and off the bench.
• USCAP 2019 even featured a workshop on training Pathologists on social media use!
• Each of these tools, both simple and complex, is aimed at unlocking the ingenuity of Pathologists to allow for better and faster decision making to guide treatment.  These tools provide easier access to their community for support and guidance and more advanced training to support their role in the personalized medicine journey.

Pharma has Arrived

The presence of pharma at USCAP further cemented the importance of biomarker-driven therapies to advancing personalized medicine.  As diagnostic companies become more well-versed in navigating pharma relationships for assay development and companion diagnostics, these Rx-Dx partnerships are spawning industry-changing advancements.  Pharma is increasing its understanding of the Anatomic Pathology (AP) sector is educating and catering to the Pathologist, clearly making its presence known in the tissue testing space.  A high value conference like USCAP allows companies such as Merck, BMS, and Bayer to not only showcase their biomarker discovery and companion diagnostics programs, but also allows for direct interface with key Pathologists for future support in clinical trials.  These Rx/Dx partnerships continue to unlock the ingenuity of Oncologists as they refine treatment paradigms and bring personalized medicine closer to the patient.

End to End Solutions from IHC to NGS

Anatomic Pathology and Molecular Diagnostics companies are increasingly paying attention to how they can support their lab customers to improve efficiency of tissue processing, staining, and analyzing tissue.  Comprehensive end-to-end solutions are becoming more commonplace and beginning to shift the testing paradigm in the laboratory, all in the name of providing better and faster patient results.

Agilent Genomics’ created a stir at USCAP 2019 as it unveiled its new end to end “staining to sequencing” workflow concept at USCAP.  With its suite of products that cover the tissue journey from slide preparation through library prep with the new Magnis™ instrument, Agilent and other leading tissue diagnostics companies (think Roche Ventana) are aiming to unlock the ingenuity of the lab professionals responsible for processing tissue samples.  With an end to end concept, personalized medicine comes closer to a reality, as more consistent and rapid results allow for earlier and more effective treatment decisions.

The Future has Arrived – Artificial Intelligence Remains a Focal Area

Perhaps the most profound advancements for the Pathologist have been in the area of the Artificial Intelligence (AI).  Despite skepticism from some members of the Pathology community about feasibility and necessity, digital pathology companies are focused on clinical evidence to demonstrate the benefits of AI to the Pathologist and to improve machine learning, cell identification, regions of interest ID, and speed.  AI tools can be broken into three buckets: 1) tools for scanning images and collaborating with the Pathology community, 2) tools for aiding in cell identification and counting, and 3) the most advanced, tools for aiding in diagnosis.

SCAN AND COLLABORATE:  Enabling high volumes of slides and improving sorting and sharing capabilities across departments or institutions enables easier collaboration and more rapid diagnosis.  This space has become increasingly crowded, with a variety of companies focusing on refining and differentiating their technologies in the hopes of ultimately commercializing for clinical use.  Notable product launches have been seen from Philips, Leica, Nikon, 3DHistech, and Huron Digital Pathology, among others.

CELL IDENTIFICATION: These novel digital advances use machine learning to identify and count relevant cells, a tedious task for Pathologists, thus affording them more time to focus on critical components of a diagnostic evaluation.  Examples include the Philips TissueMark and the Bioview integrated all-in-one imaging system.  Despite the potential upside of this machine learning tool, this feature has been feared by many Pathologists over concerns about accuracy and reliability.

ANALYSIS: These products use deep learning algorithms to pull from a variety of sources in addition to the tissue images to aid in diagnosis.  For example, the Roche (Ventana) DP 200 slide scanner now includes a Companion Algorithm software designed to aid pathologists in assessment, measurement, and diagnosis of breast cancer.  These software tools can be truly game changing once a body of evidence is accepted around reliability.

Notable Startups

A number of young companies also have their eye on AI solutions to support more rapid and accurate diagnosis, including, but not limited to:

• PathAI: This Cambridge, MA-based company is evolving machine learning for drug development and clinical work in collaboration with Phillips.  The company received $11M investor funding in 2017.
• Paige.AI: In March 2019, Paige.AI received Breakthrough Device designation from the FDA for their deep learning software; their collaboration and exclusive rights to a Memorial Sloan Kettering archive of 25 million slide images to train their system to machine learn make this group a serious threat to others in the space.  The company Received $25M investor funding in 2018.
• Nucleai: The Israel-based startup, founded in 2017 with a $5 million seed round under their belt, is focused on development of image recognition capabilities, with information drawn from patients’ medical records and genomics data.

The level of investment and caliber of technologies being brought to market and being continuously improved leads us to believe that AI will become a critical piece of the personalized medicine puzzle.  Through automated and standardized tissue slide review mechanisms, patients will begin to get answers more rapidly than ever before.

So, What Next?

As we reflect on this convergence of innovation from tech companies, pharma, and IVD developers alike, I can’t help but ponder whether we are, to quote Lady Gaga, on the edge of glory.

Imagine a day where an Oncologist receives results from all NGS, IHC, and FISH tissue testing results within 48 hours of surgery so that patients can start treatment immediately and not have to anxiously await results for weeks.

At Market Ready Rx, we can support you to make this a reality.  Allow us to help you unlock your ingenuity as a commercial partner at your side to help you define your strategy and deliver your personalized medicine solutions to the market.

Contact Market Ready Rx for an introductory consultation should you wish to explore how Market Ready Rx can support your organization.

• We are a different kind of IVD marketing consultancy
• We blur the lines between strategic consultancy and tactical agency to support every stage of the commercial launch lifecycle
• Because we know best practices and have an efficient launch methodology and tools, clients can rest assured that we’ll get it done at the highest quality, on time and on budget.

To learn more about our services, checkout:  marketreadyrx.com