May 22, 2018
The diverse city of Vancouver set the perfect tone for learning and collaborating at the 2018 USCAP meeting; a welcoming city, rich with breathtaking vistas, great Canadian hospitality and fantastic international cuisine. Having attended USCAP for more than 15 years, I was impressed by the meeting’s progress; evolving beyond dry lectures with morphology slide reviews to an USCAP where pathologists tackle big topics in molecular pathology and innovative translational research.
The theme selected this year by the President of USCAP, Chris Fletcher MD, was “Geared to Learn”- the machinery of engagement and learning, a fitting theme emphasizing the critical role of the pathologist in the Precision Medicine patient care path. Drawing a total of 5,021 global participants (1,382 from outside the US), this meeting is the largest gathering of clinical pathologists in the world – attracting global industry suppliers due to the international visibility.
My focus during USCAP 2018 in March was a simple one - to learn what’s new in clinical diagnostics. I was impressed by the level of heavy hitting industry firms ranging from IBM Watson, showcasing their next generation sequencing (NGS) annotation and reporting software, to Philips, who launched the first FDA approved whole slide imaging platform for primary diagnosis. It was interesting to note the continued commitment to pathology by pharmaceutical giants with therapy directed PD-L1 testing (Merck, Bristol-Myers Squibb and Astra Zeneca). I am pleased to share a recap of what surprised us, what impressed us, and a virtual view of the USCAP exhibit hall.
DIGITAL PATHOLOGY STEALS THE SHOW
Initially, I was a bit taken aback by the countless digital pathology scanner and cloud-based software solutions in the USCAP Exhibit Hall. Since the debut of the first image analysis systems marketed by Aperio and Chromavision in 2002 for breast cancer prognostic reporting , traction and adoption are still very low in the clinical lab. We stopped by the Digital Pathology Association (DPA) to get a better sense of why digital pathology solutions have not been adopted in the clinical lab beyond an estimated 30%. I was warmly welcomed at the booth, where they shared the DPA’s optimism about the future of whole slide image, with the recent FDA approval for Philips IntelliSite Pathology solutions.
We dug a little deeper into the Digital Pathology Association’s website, learning that the DPA has evolved to a focus on the application of digital pathology or what you can do with the slide once it’s digitized. Applications such as telepathology, image analysis, education, second opinions, and primary diagnosis are now the emphasis instead of on the technology itself. The DPA is focused on supporting FDA approval for whole slide imaging, a goal now accomplished with the Philips FDA approval for primary diagnosis. They now have a steep road ahead to drive adoption. In the future, they will be focused on driving adoption of whole slide imaging for primary diagnosis.
The digital buzzword at the show was artificial intelligence (AI) also known as machine learning, adaptive learning or deep learning. AI software is a learning system that establishes algorithms and neural networks to learn how an individual or pathology group selects certain morphological characteristics, improving diagnosis over time. The following summarizes a variety of digital pathology artificial intelligence systems which we found interesting.
Philips’ IntelliSite Pathology system, the first and only digital pathology solution marketed for primary diagnostic use in the U.S., helps pathologists manage the scanning, storing, presenting, reviewing, and sharing of information across labs and lab networks
Another advance in computational pathology was the Philips TissueMark, a software tool to aid in identifying insufficient samples for molecular tests with accurate cellularity guidance. The AI-based application enables region of interest detection and cellular profile estimation in whole slide images (WSI) of lung histology, lung cytology, colon and breast FFPE, and H&E tissue samples in 60 seconds
Leica Biosystems has integrated Aperio, an established leader in the whole slide imaging space, as a complement to their advanced staining automation. The Aperio offerings include scanners and digital pathology software which can be fully integrated into a lab workflow. Also available are image analysis tools for pathologists, including many “trainable” algorithms for IHC, ISH/FISH, Immunofluorescence, and Pattern Recognition, along with validated algorithms for the quantification of breast markers.
An exciting company which we found particularly interesting for their focus on laboratory workflow, is Proscia, with their cloud- based digital pathology learning system. While the company is currently focused on RUO Digital Applications for education, they have tools which enable the clinical lab to complete pathology reviews more efficiently. Proscia Connect is currently 6,000 customers strong as of January. A histotech uploads slides from all major scanners (scanner agnostic) to a cloud-based software module for ease of pathologist review. The system is standardized for digital pathology data management, collaboration, and image analysis and offers diverse and powerful applications for analysis of biomarkers, tissue features, and tumor characteristics.
Techcyte is a deep learning software platform with artificial intelligence pattern recognition with a Cytology focus. While currently RUO in the US, the deep learning software platform uses image analysis to assist pathologists in making efficient diagnostic decisions.
Motic, based out of China, is a digital pathology company levering its optical expertise, with the aim of differentiating through ease of use and high-quality images. At USCAP, the company announced the launch of two new Whole Slide Imaging scanners, Motic EasyScan One and Motic EasyScan Infinity, for desktop scanning and high capacity scanning, respectively.
Corista featured their Digital Pathology Network Platform (DP3) as the only image-centric pathology workflow solution integrating multiple facilities, scanners, physicians, patients and LISs in the extended healthcare enterprise. The DP3 comprehensive clinical workflow suite for digital pathology establishes tumor boards in minutes, automates QA, and launches real-time peer reviews. DP3 was awarded the Frost & Sullivan Product Innovation Award in 2014.
Inspirata offers a digital pathology workflow solution focused on automating high-throughput slide scanning to manage a high-volume institution’s entire case load and to integrate data feeds from disparate clinical systems such as Anatomic and Molecular Pathology Systems, Radiology System, Endoscopy System and Electronic Health Records (EHR). They have also secured regulatory-cleared digital pathology solutions that are now available in the U.S., Canada and Europe.
Olympus Life Science , a trusted microscope company, focused on their core competency by offering a microscope incorporated with a whole slide consultation called the MIA (multiple image alignment) system, which takes a slide image of H&E and overlays it with other stains for ease of interpretation in the region of interest.
MOLECULAR DIAGNOSTICS ARRIVES AT USCAP
The ongoing convergence of tissue diagnostics and molecular diagnostics was evident at this year’s USCAP show. Software products were plentiful, to support everything from information transport to NGS interpretation. Of note was IBM Watson, delivering a platform which enables simple VCF file annotation and curation of tier 2 NGS variants, as well as tier 1 FDA approved reporting for clinical practice. The system on display illustrated:
- Drug evidence to guide therapy in tier 2 variants
- Remote diagnosis with live streaming in real time
- Secure IT medical grade software compliant with hospital EHR systems with Encryption and HIPPA compliant report.
ACDBio, now a Biotechne brand, has advanced their innovative RNAscope® assay to detect mRNA and ncRNA targets of >300bp. They have partnered with Leica Biosystems to develop the fully automated RNAscope® ISH technology for clinical applications such as HPV, optimized for use on the Bond III, and are supporting companion diagnostics through biomarker discovery.
PHARMA AT USCAP
As pathologists grow more relevant in the patient care path for precision medicine, pharma companies such as Merck, Bristol-Myers Squibb, and Astra Zeneca, all with an interest in PD-L1 tissue testing, are close at hand to ensure that pathologists are educated on the clinical relevance of their drugs. Of note was the BMS booth, where patients were being interviewed by pathologists on their diagnostic test experience with lung cancer and melanoma.
The presence of early stage biotech companies to USCAP is indicative that the oncologist pathologist relationship is stronger than ever. One example is Stemline Therapeutics, Inc., an early stage biopharma company developing a novel oncology therapeutic called Stemline 123 for relapse refractory AML patients. The compound is currently achieving 40% Response Rate in relapse refractory AML biomarker positive CD123 patients. Stemline Tx is aiming a first line approval for AML and this show was relevant to their understanding of pathologists’ priorities.
THE HEART OF USCAP- TISSUE TEST AUTOMATION
Traditional Tissue Histology and Advanced Staining companies were still present with many traditional platforms featured, as manufacturers catered to the core histologist and histotechnologist attendee base. Products of note included:
Biogenex with their Xmatrx automation
- RNA SSHA biomarker for ISH
- Tumor of unknown origin tests for micro RNA
Sakura was in full force with their robust instrument systems
- The revolutionary Tissue-Tek automated microtome slide sectioner
- The Tissue-Tek Genie® Advanced Staining System: the first and only fully automated, true random access stainer for immunohistochemistry (IHC) and in situ hybridization (ISH) that features 30 completely independent slide stations
Stat Lab in collaboration with Sienna Cancer Diagnostics launched the hTERT Bladder cancer test
- Cytospins and ThinPrep specimens
- In-vitro diagnostic (IVD) assay for the detection of hTERT (human telomerase reverse transcriptase), a component of the enzyme telomerase, immunocytochemistry (ICC) test for use as an adjunct to urine cytology.
As tissue diagnostics becomes ever-more personalized, these core Anatomic Pathology vendors recognize the need for plug and play solutions to support the molecular pathology workflow downstream.
I was impressed by the quality of vendors and the interest by Pathologists to engage in discussions about precision medicine and learning digital pathology systems. USCAP will remain on my list of MUST ATTEND shows for years to come.
*Note that the above summary is not all-encompassing of the many innovative technologies displayed at USCAP 2018, but rather a high-level synopsis of the direction in which the tissue diagnostics market is moving.