News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Attention All Surgical Pathologists: Algorithms for Automated Primary Diagnosis of Digital Pathology Images Likely to Gain Regulatory Clearance in Near Future

Hello primary diagnosis of digital pathology images via artificial intelligence! Goodbye light microscopes!

Digital pathology is poised to take a great leap forward. Within as few as 12 months, image analysis algorithms may gain regulatory clearance in the United States for use in primary diagnosis of whole-slide images (WSIs) for certain types of cancer. Such a development will be a true revolution in surgical pathology and would signal the beginning of the end of the light microscope era.

A harbinger of this new age of digital pathology and automated image analysis is a press release issued last week by Ibex Medical Analytics of Tel Aviv, Israel. The company announced that its Galen artificial intelligence (AI)-powered platform for use in the primary diagnosis of specific cancers will undergo an accelerated review by the Food and Drug Administration (FDA).

FDA’s ‘Breakthrough Device Designation’ for Pathology AI Platform

Ibex stated that “The FDA’s Breakthrough Device Designation is granted to technologies that have the potential to provide more effective treatment or diagnosis of life-threatening diseases, such as cancer. The designation enables close collaboration with, and expedited review by, the FDA, and provides formal acknowledgement of the Galen platform’s utility and potential benefit as well as the robustness of Ibex’s clinical program.”

“All surgical pathologists should recognize that, once the FDA begins to review and clear algorithms capable of using digital pathology images to make an accurate primary diagnosis of cancer, their daily work routines will be forever changed,” stated Robert L. Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report. “Essentially, as FDA clearance is for use in clinical care, pathology image analysis algorithms powered by AI will put anatomic pathology on the road to total automation.

“Clinical laboratories have seen the same dynamic, with CBCs (complete blood counts) being a prime example. Through the 1970s, clinical laboratories employed substantial numbers of hematechnologists [hematechs],” he continued. “Hematechs used a light microscope to look at a smear of whole blood that was on a glass slide with a grid. The hematechs would manually count and record the number of red and white blood cells.

“That changed when in vitro diagnostics (IVD) manufacturers used the Coulter Principle and the Coulter Counter to automate counting the red and white blood cells in a sample, along with automatically calculating the differentials,” Michel explained. “Today, only clinical lab old-timers remember hematechs. Yet, the automation of CBCs eventually created more employment for medical technologists (MTs). That’s because the automated instruments needed to be operated by someone trained to understand the science and medicine involved in performing the assay.”

Primary Diagnosis of Cancer with an AI-Powered Algorithm

Surgical pathology is poised to go down a similar path. Use of a light microscope to conduct a manual review of glass slides will be supplanted by use of digital pathology images and the coming next generation of image analysis algorithms. Whether these algorithms are called machine learning, computational pathology, or artificial intelligence, the outcome is the same—eventually these algorithms will make an accurate primary diagnosis from a digital image, with comparable quality to a trained anatomic pathologist.

How much of a threat is automated analysis of digital pathology images? Computer scientist/engineer Ajit Singh, PhD, a partner at Artiman Ventures and an authority on digital pathology, believes that artificial intelligence is at the stage where it can be used for primary diagnosis for two types of common cancer: One is prostate cancer, and the other is dermatology.

Ajit Singh, PhD speaking at the Executive War College

On June 17, Ajit Singh, PhD (above), Partner at Artiman Ventures, will lead a special webinar and roundtable discussion for all surgical pathologists and their practice administrators on the coming arrival of artificial intelligence-powered algorithms to aid in the primary diagnosis of certain cancers. Regulatory approval for such solutions may happen by the end of this year. Such a development would accelerate the transition from light microscopes to a fully digital pathology workflow. Singh is shown above addressing the 2018 Executive War College. (Photo copyright: The Dark Report.)

“This is particularly true of prostate cancer, which has far fewer variables compared to breast cancer,” stated Singh in an interview published by The Dark Report in April. (See TDR, “Is Artificial Intelligence Ready for First Use in Anatomic Pathology?” April 12, 2021.)

“It is now possible to do a secondary read, and even a first read, in prostate cancer with an AI system alone. In cases where there may be uncertainty, a pathologist can review the images. Now, this is specifically for prostate cancer, and I think this is a tremendous positive development for diagnostic pathways,” he added.

Use of Digital Pathology with AI-Algorithms Changes Diagnostics

Pathologists who are wedded to their light microscopes will want to pay attention to the impending arrival of a fully digital pathology system, where glass slides are converted to whole-slide images and then digitized. From that point, the surgical pathologist becomes the coach and quarterback of an individual patient’s case. The pathologist guides the AI-powered image analysis algorithms. Based on the results, the pathologist then orders supplementary tests appropriate to developing a robust diagnosis and guiding therapeutic decisions for that patient’s cancer.

In his interview with The Dark Report, Singh explained that the first effective AI-powered algorithms in digital pathology will be developed for prostate cancer and skin cancer. Both types of cancer are much less complex than, say, breast cancer. Moreover, the AI developers have decades of prostate cancer and melanoma cases where the biopsies, diagnoses, and downstream patient outcomes create a rich data base from which the algorithms can be trained and tuned.

To help surgical pathologists, pathologist-business leaders, and pathology group practice administrators understand the rapid developments in AI-powered digital pathology analysis, Dark Daily is conducting “Clinical-Grade Artificial Intelligence (AI) for Your Pathology Lab: What’s Ready Now, What’s Coming Soon, and How Pathologists Can Profit from Its Use,” on Thursday, June 17, 2021, from 1:00 PM to 2:30 PM EDT.

This webinar is organized as a roundtable discussion so participants can interact with the expert panelists. The Chair and Moderator is Ajit Singh, PhD, Adjunct Professor at the Stanford School of Medicine and Partner at Artiman Ventures.

Panelists for June 17 webinar, Clinical-Grade Artificial Intelligence (AI) for Your Pathology Lab: What’s Ready Now, What’s Coming Soon, and How Pathologists Can Profit from Its Use

The panelists (above) represent academic pathology, community hospital pathology, and the commercial sector. They are:

Because the arrival of automated analysis of digital pathology images will transform the daily routine of every surgical pathologist, it would be beneficial for all pathology groups to have one or more of their pathologists register and participate in this critical webinar.

The roundtable discussion will help them understand how quickly AI-powered image analysis is expected be cleared for use by the FDA in such diseases as prostate cancer and melanomas. Both types of cancers generate high volumes of case referrals to the nation’s pathologists, so potential for disruption to long-standing client relationships, and the possible loss of revenue for pathology groups that delay their adoption of digital pathology, can be significant.

On the flip side, community pathology groups that jump on the digital pathology bandwagon early and with the right preparation will be positioned to build stronger client relationships, increase subspecialty case referrals, and generate additional streams of revenue that boost partner compensation within their group.

Act now to guarantee your place at this important webinar. Click HERE to register, or copy and paste the URL https://www.darkdaily.com/webinar/clinical-grade-artificial-intelligence-for-your-pathology-lab/ into your browser.

Also, because so many pathologists are working remotely, Dark Daily has arranged special group rates for pathology practices that would like their surgical pathologists to participate in this important webinar and roundtable discussion on AI-powered primary diagnosis of pathology images. Inquire at info@darkreport.com or call 512-264-7103.

—Michael McBride

Related Information:

Ibex Granted FDA Breakthrough Device Designation: Ibex’s Galen AI-powered platform is recognized by the FDA as breakthrough technology with the potential to more effectively diagnose cancer

Is Artificial Intelligence Ready for First Use in Anatomic Pathology?

Innovative Medical and Pathology Laboratories in Canada Shared Successes in Improving Patient Outcomes at Last Week’s Executive Edge Conference

Pathologists and clinical lab leaders heard about innovations in microbiology automation, genetic testing, use of mass spectrometry, and lab informatics advances

DATELINE: TORONTO, ONTARIO: From across Canada, clinical laboratory executives, pathologists, and health service administrators assembled last week to attend Executive Edge, this nation’s largest conference on innovations in the management and operation of medical laboratories.

Healthcare in Canada faces challenges that are common to healthcare systems in most developed countries. Demand for healthcare is growing at a fast pace due to an aging population and increased incidence of chronic disease. Government budgets cannot grow fast enough to meet the rising demand for healthcare services. (more…)

Mouth Pipetting: Blogger Reminds Medical Laboratory Technologists of an Era When This Was Leading Source of Clinical Laboratory-acquired Infections

Today, cheap and accurate mechanical pipettes are used by clinical pathology laboratories, although mouth pipetting, a dangerous medical lab practice, is still used in developing nations

Mouth pipetting was the topic of a recent blog published by Body Horrors. The blogger recalled a time when clinical laboratory professionals routinely mouth pipetted specimens.

Mouth pipetting is the practice of using one’s mouth to suck a desired volume of a medical laboratory specimen–blood, urine, cell cultures and other microbial stews–into an open-ended tube, using the reduced air pressure created by sucking to hold the specimen in place while moving it to another vessel. (more…)

Positive News for Clinical Pathology Laboratories on Compensation for Medical Technologists and Clinical Laboratory Scientists

Laboratory professionals with four years of higher education do earn comparable compensation when compared to other professions requiring a four-year degree

Never say that readers of Dark Daily are not ready to express opinions and speak out! On Monday, we published an e-briefing that reported on the inclusion of “Medical and Clinical Laboratory Technicians” on a list of the “Most-Educated and Least-Paid Professions” that was compiled by a reporter at 24/7 Wall St.

Essentially, using data from the U.S. Bureau of Labor Statistics’ Occupational Employment Statistics Database, this reporter had ranked “Medical and Clinical Laboratory Technicians” as number three of seven professions which were most-educated and least paid. (See Dark Daily, Bad News for Clinical Pathology Laboratories: Med Techs Rank Number 3 on List of Most-Educated and Least-Paid Professions,” December 19, 2011.) (more…)

Experts Predict Shortage of Clinical Laboratory Labor Will Create Need for More Sophisticated Laboratory Information Systems

Recent reports show why labs need more robust laboratory information systems (LIS), including a shrinking workforce, new requirements to connect to EMRs in hospitals and physicians’ offices, and the development of health information exchanges.

Clinical laboratories nationwide are realizing they need new and more powerful laboratory information systems (LIS) as they seek to process larger volumes of medical laboratory tests with a shrinking number of medical technologists and clinical laboratory scientists.

In response to the critical shortages of MTs, CLSs, and other laboratory scientists, most clinical laboratories are beefing up automation in all areas of the lab. From the high-volume core chemistry/hematology laboratory to microbiology and histology, laboratory automation systems are becoming ubiquitous. But all this lab automation increases the need to use information technologies to manage both automation and the flow of specimens through the laboratory.

A report published earlier this year by Kalorama Information of Rockville, Maryland, actually links the shortage of skilled medical laboratory staff as one of the most important factors in fostering growth in the LIS market. Researchers estimated the size of the LIS market at $800 million and predicted that it would grow about 6% annually for the next few years.

As pathologists and clinical laboratory managers know, labor accounts for more than 60% of the cost of producing medical laboratory test results. The Kalorama report stated that laboratory automation and better information management systems can reduce the number of manual procedures and tasks in the typical medical laboratory, In turn, this helps optimize labor efficiency, said the report titled, Laboratory Information Systems (LIS / LIMS) Markets. (more…)

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