As the worldwide demand for histopathology services increases faster than the increase in the number of anatomic pathologist and histopathologists, a DP platform that suggests courses of treatments may be a boon to cancer diagnostics
Europe may become Ground Zero for the widespread adoption of whole-slide imaging (WSI), digital pathology (DP) workflow, and the use of image-analysis algorithms to make primary diagnoses of cancer. Several forward-looking histopathology laboratories in different European countries are moving swiftly to adopt these innovative technologies.
Clinical laboratories and anatomic pathology groups worldwide have watched digital pathology tools evolve into powerful diagnostic aids. And though not yet employed for primary diagnoses, thanks to artificial intelligence (AI) and machine learning many DP platforms are moving closer to daily clinical use and new collaborations with pathologists who utilize the technology to confirm cancer and other chronic diseases.
Now, Swiss company Unilabs, one of the largest laboratory, imaging, and pathology diagnostic developers in Europe, and Israel-based Ibex Medical Analytics, developer of AI-based digital pathology and cancer diagnostics, have teamed together to deploy “Ibex’s multi-tissue AI-powered Galen platform” across 16 European nations, according to a Unilabs press release.
Though not cleared by the federal Food and Drug Administration (FDA) for clinical use in the US, the FDA recently granted Breakthrough Device Designation to Ibex’s Galen platform. This designation is part of the FDA’s Breakthrough Device Program which was created to help expedite the development, assessment, and review of certain medical devices and products that promise to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
Benefits of AI-Digital Pathology to Pathologists, Clinical Labs, and Patients
According to Ibex’s website, the Galen DP platform uses AI algorithms to analyze images from breast and prostate tissue biopsies and provide insights that help pathologists and physicians determine the best treatment options for cancer patients.
This will, Ibex says, give pathologists “More time to dedicate to complex cases and research,” and will make reading biopsies “Less tedious, tiring, and stressful.”
Patients, according to Ibex, benefit from “Increased diagnostic accuracy” and “More objective results.”
And pathology laboratories benefit from “Increased efficiency, decreased turnaround time, and improved quality of service,” Ibex claims.
According to the press release, AI-generated insights can include “case prioritization worklists, cancer heatmaps, tumor grading and measurements, streamlined reporting tools and more.”
This more collaborative approach between pathologists and AI is a somewhat different use of digital pathology, which primarily has been used to confirm pathologists’ diagnoses, rather than helping to identify cancer and suggest courses of treatment to pathologists.
“This cutting-edge AI technology will help our teams quickly prioritize urgent cases, speed up diagnosis, and improve quality by adding an extra set of digital eyes,” said Christian Rebhan, MD, PhD (above), Chief Medical and Operations Officer at Unilabs, in the press release. “When it comes to cancer, the earlier you catch it, the better the prognosis—so getting us critical results faster will help save lives.” (Photo copyright: Unilabs.)
AI-based First and Second Reads
The utilization of the Galen platform will first be rolled out nationally in Sweden and then deployed in sixteen other countries. The AI-based DP platform is CE marked in the European Union for breast and prostate cancer detection in multiple workflows.
“The partnership with Ibex underlines Unilabs’ pioneering role in Digital Pathology and represents yet another step in our ambition to become the most digitally-enabled provider of diagnostic services in Europe,” Rebhan stated.
The Ibex website explains that the Galen platform is divided into two parts—First Read and Second Read:
The First Read “is an AI-based diagnostics application that aims to help pathologists significantly reduce turnaround time and improve diagnostic accuracy. The application uses a highly accurate AI algorithm to analyze slides prior to the pathologist and provides decision support tools that enable focusing on cancerous slides and areas of interest, streamline reporting, improve lab efficiency, and increase diagnostic confidence.”
The Second Read “is an AI-based diagnostics and quality control application that helps pathologists enhance diagnostic accuracy with no impact on routine workflow. The application analyzes slides in parallel with the pathologist and alerts in case of discrepancies with high clinical significance (e.g., a missed cancer), thereby providing a safety net that reduces error rates and enables a more efficient workflow.”
“Ibex is transforming cancer diagnosis with innovative AI solutions across the diagnostic pathway,” said Joseph Mossel, Chief Executive Officer and co-founder of Ibex, in the press release. “We are excited to partner with Unilabs to deploy our AI solutions and empower their pathologists with faster turnaround times and quality diagnosis. This cooperation follows a thorough evaluation of our technology at Unilabs and demonstrates the robustness and utility of our platform for everyday clinical practice.”
Use of AI in Pathology Increases as Number of Actual Pathologists Declines
Developers like Unilabs and Ibex believe that DP platforms driven by AI image analysis algorithms can help pathologists be more productive and can shorten the time it takes for physicians to make diagnoses and issue reports to patients.
This may be coming at a critical time. As nations around the globe face increasing shortages of pathologists and histopathologists, the use of AI in digital pathology could become more critical for disease diagnosis and treatment.
A 2019 Medscape survey stated that “One-third of active pathologists are burned out,” and that many pathologists are on the road to retirement.
And in the same year, Fierce Healthcare noted that in a 2013 study, “researchers found that more than 40% of pathologists were 55 or older. They predicted that retirements would reach their apex in 2021. Consequently, by the end of next decade, the United States will be short more than 5,700 pathologists.”
Dark Daily previously reported on the growing global shortage of pathologists going back to 2011.
Even China is struggling to keep up with demand for anatomic pathologists. In 2017, Dark Daily wrote, “China is currently facing a severe shortage of anatomic pathologists, which blocks patients’ access to quality care. The relatively small number of pathologists are often overworked, even as more patients want access to specialty care for illnesses. Some hospitals in China do not even have pathologists on staff. Thus, they rely on understaffed anatomic pathology departments at other facilities, or they use imaging only for diagnoses.”
Thus, it may be time for an AI-driven digital platform to arrive that can speed up and increase the accuracy of the cancer diagnostics process for pathologists, clinical laboratories, and patients alike.
There are multiple companies rapidly developing AI, machine learning, and image analysis products for diagnosing diseases. Pathologists should expect progress in this field to be ongoing and new capabilities regularly introduced into the market.
FDA cites ‘risk of false results’ and concerns about labeling and ‘performance claims’ in its official warning letter to Innova, a company with connections to Chinese firms
By many standards, the US government’s response to the COVID-19 pandemic has been phenomenal. However, the many emergency use authorizations (EUAs) awarded by the US federal Food and Drug Administration (FDA) to bring as many COVID-19 tests to market as quickly as possible means some of those tests in use today at clinical laboratories nationwide have not undergone the normal pre-market review and clearance typically required by the FDA.
But in its recall announcement, the FDA described Innova’s recall of its SARS-CoV-2 Antigen Rapid Test as a “Class 1 recall” and gave the stern warning, “Use of these devices may cause serious injuries or death.”
And in its public Safety Communication, the federal agency wrote, “The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health. In addition, labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests. Finally, the test has not been authorized, cleared, or approved by the FDA for commercial distribution or use in the United States, as required by law.”
In May 2021, Innova Medical Group of Pasadena, Calif., announced it would start producing millions of its COVID-19 SARS-CoV-2 Antigen Rapid test kits (above) per day in the United Kingdom by opening a production facility in Rhymney, South Wales. (Photo copyright: Innova Medical Group, Inc.)
FDA Warns Public to Stop Using Innova’s Rapid Antigen COVID-19 Test
Widescale COVID-19 testing has been viewed as key to containing community spread of the SARS-CoV-2 coronavirus, and fast, inexpensive rapid COVID-19 testing is a necessity in that fight.
However, as clinical laboratory scientists know, rapid tests are not as specific as molecular polymerase chain reaction (PCR) tests, which means there is a higher chance of false negatives and false positives with a COVID-19 rapid test than with a molecular test. When diagnosing COVID-19, a PCR test is considered the gold-standard, though results can take multiple days to produce.
Nevertheless, according to the Innova Europe website, the Innova rapid antigen test has a sensitivity on symptomatic individuals of 97% and a specificity of 99% and is the most widely used test in the world. More than 500 million units are in circulation.
Regardless, in its June 10th warning, the FDA called for the public to stop using the Innova Medical Group SARS-CoV-2 Antigen Rapid test for diagnostic use.
“The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health,” the FDA stated. “In addition, labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests. Finally, the test has not been authorized, cleared, or approved by the FDA for commercial distribution or use in the United States, as required by law.”
In its warning, the FDA recommended anyone in possession of Innova tests “destroy the tests by placing them in the trash” or return the tests to Innova.
The Innova SARS-CoV-2 Antigen Rapid test is also distributed under the names:
Innova COVID-19 Self-Test Kit (3T Configuration),
Innova Medical Group SARS-CoV-2-Antigen Rapid Test (7T Configuration), and
Innova Medical Group SARS-CoV-2-Antigen Rapid Test (25T Configuration).
Innova Medical Group was formed in March 2020 by Charles Huang, PhD, founder and chairman of private-equity firm Pasaca Capital. The Pasaca website states Innova worked with its primary contract manufacturer, China-based Xiamen Biotime Biotechnology Co., for several months to design “a highly accurate rapid antigen test for COVID-19.”
“The simple test takes less than five minutes to administer and generates results in as little as 20 minutes without the need for a machine,” the website states. “Equally important, Innova and its partner have been able to manufacture the product at scale, presently in excess of ten million kits per day.”
However, The Los Angeles Times claims that in September 2020 Innova “secured a vast supply of rapid coronavirus tests from an obscure Chinese manufacturer before established pharmaceutical companies could do so.” The LA Times adds that Innova distributed more than 70,000 tests in the United States even though the FDA had not acted on Innova’s application to sell its tests domestically.
This may have contributed to the FDA’s dire warning to discontinue use and discard the Innova tests.
UK’s MHRA Disagrees with FDA Warning
But in the UK, it is a different story. According to The Guardian, Innova’s lateral flow tests are the cornerstone of “Operation Moonshot”, the government’s mass testing plan aimed at reducing community transmission by identifying asymptomatic COVID-19 positive people using an inexpensive, quick-response test distributed for home use and to workplaces, schools, and test centers.
In “Rapid COVID Tests Used in Mass UK Programme Get Scathing US Report,” The Guardian reports that “criticism of the Innova test has been fierce” in the UK following the FDA’s “scathing review” of its rapid antigen test. However, after investigating the concerns raised by the FDA, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) reiterated that the Innova lateral flow tests were safe to use.
“We have now concluded our review of the risk assessment and are satisfied that no further action is necessary or advisable at this time,” said Graeme Tunbridge, MHRA Director of Devices, in a UK government response statement which announced that the MHRA was extending the Exceptional Use Authorization (EUA) for the tests use in its national asymptomatic testing program through Aug. 28, 2021. “This has allowed us to extend the EUA to allow ongoing supply of these [lateral flow devices] over the coming months. People can be assured of the MHRA’s work to continuously monitor the tests in use; as is our standard process.”
Innova Defends Its Test, FDA Repeats Its Warning
An Innova spokesperson told The Guardian: “The Innova rapid antigen test has been widely used, studied, tested, scrutinized and analyzed with data supporting the efficacy of the test from the largest mass testing program out of the UK. Innova is confident about the quality of its product.”
However, the FDA maintains Innova’s COVID-19 lateral flow test included labeling that provided “false and misleading” estimates of the test’s clinical performance. In its warning letter to Innova, the FDA also pointed out that the clinical study data Innova submitted as part of its EUA request was “identical to data previously provided by other manufacturers in their EUA requests. The data reliability and accuracy issues noted herein raise significant concerns that the performance of the SARS-CoV-2 Antigen Rapid Qualitative Test has not been adequately established, and that the products distributed by Innova without FDA approval, clearance, or authorization could present a serious risk to the public health.”
Pathologists and clinical laboratory professionals in this country will want to watch carefully to see if efforts to increase regulatory scrutiny of diagnostic tests in the UK spills across the Atlantic.
Since all Americans have access to free COVID-19 vaccines, many pathologists and clinical lab managers will ask if this test is even necessary. Some experts say “maybe”
Here’s another example of genetic test developers who are willing to push boundaries and sell a diagnostic test directly to consumers that has some diagnostic experts and pathologists challenging its clinical validity.
The test was developed by molecular diagnostics company Genetic Technologies Ltd. (NASDAQ:GENE) of Melbourne, Australia, and, according to an article in Science, is an at-home saliva test that “combines genetic data with someone’s age, sex, and pre-existing medical conditions to predict their risk of becoming extremely ill from COVID-19.”
In a non-peer-reviewed preprint, titled, “Development and Validation of a Clinical and Genetic Model for Predicting Risk of Severe COVID-19,” Genetic Technologies’ Chief Scientific Officer Richard Allman, PhD, and Senior Biostatistician and the study’s first author, Gillian Dite, PhD, wrote, “Using SARS-CoV-2 positive participants from the UK Biobank, we developed and validated a clinical and genetic model to predict risk of severe COVID-19. … Accurate prediction of individual risk is possible and will be important in regions where vaccines are not widely available or where people refuse or are disqualified from vaccination, especially given uncertainty about the extent of infection transmission among vaccinated people and the emergence of SARS-CoV-2 variants of concern.”
But since every American already has access to free COVID-19 vaccines, one wonders why this test would be launched in the US?
Determining Risk for COVID-19 Infection
Can a genetic test predict an individual’s risk of contracting a SARS-CoV-2 infection that would require hospitalization or cause death? Genetic Technologies and its US partner, Infinity BiologiX (IBX) of Piscataway, N.J., believe so.
According to a Genetic Technologies news release, the saliva test, which reportedly costs $175, enables a “leading-edge risk assessment that estimates your personal risk of severe disease,” IBX says on its website.
The at-home saliva-based test, which is intended for people age 18 and older, gives a risk score for contracting a serious COVID-19 case based on genetic and clinical information, IBX stated in its own news release.
The two companies partnered with Vault Health, a “virtual platform for telemedicine and diagnostics” developer, to distribute, and sell the COVID-19 Serious Disease Risk Test in the US.
In the IBX news release, IBX’s Chief Executive Officer, Robin Grimwood, said, “We see this initial agreement for the sale and distribution of Genetic Technologies’ COVID-19 Risk Test (above) as a critical collaboration in line with our mission to understand the genetic causes of common, complex diseases and to discover diagnoses, treatments and, eventually, cures for these diseases.” However, as Dark Daily’s sister publication The Dark Report previously reported, some geneticists, epidemiologists, and clinical laboratory professionals have expressed concerns. (Photo copyright: Infinity BiologiX.)
Is There a Place for Genetic COVID-19 Risk Test in the US?
“Alongside existing treatment options and vaccines, we believe this test will enable more insightful decisions for states, workplaces, and individuals,” said Simon Morriss, Genetic Technologies’ CEO, in the news release.
Meanwhile, some experts are uncertain about predictive types of testing for the SARS-CoV-2 coronavirus. “I think it’s premature to use a genetic test to predict a person’s likely COVID-19 severity. We don’t understand exactly what these genetic variants mean or how they affect disease,” epidemiologist Priya Duggal PhD, a professor in the Genetics Epidemiology Division at the Johns Hopkins University School of Public Health, told Science.
According to Science, “The test debuts in a regulatory gray zone …. The two companies did not seek [FDA] approval for validity because, [Genetic Technologies Chief Scientific Officer Richard Allman] says, the test is not a direct-to-consumer product that falls under its review. After a customer receives results from IBX’s federally-approved labs, they can consult with a ‘telehealth’ physician.”
“We are uniquely and strategically positioned with our partners to deliver the test and provide remote telehealth services and reporting, utilizing our extensive array capability and capacity across a number of platforms,” Grimwood said in the IBX news release.
However, Science reported that “Several geneticists who reviewed the company’s preprint” said “the test needs to be validated in other, more diverse populations than one detailed in the UK Biobank, and they wonder whether its predictions are reliable for people infected with new SARS-CoV-2 variants.”
“It’s a good start, but by no means is it calibrated or validated sufficiently to say this is a test I would take, or my wife should take,” cancer geneticist Stephen Chanock, MD, Director of the Division of Cancer Epidemiology and Genetics at the National Cancer Institute, National Institutes of Health, told Science.
The question remains unanswered as to why a genetic risk test for SARS-CoV-2 and its variants is needed in the United States. Nevertheless, clinical laboratory leaders and pathologists may want to monitor these developments for new biomarkers and COVID-19 diagnostics.
Following a nearly two-year disruption due to the SARS-CoV-2 pandemic, pathologists and clinical laboratory professionals once again have an opportunity to gather and learn from each other
It is good news that the daily number of new cases of COVID-19 continue declining here in the United States. That fact, and the growing number of vaccinations, have encouraged state and federal officials to lift many restrictions on business and social activities.
Clinical laboratories are watching a big drop in the daily number of COVID-19 tests they perform, even as routine test volumes climb and more patients show up in doctors’ offices for the typical mix of ailments and health conditions.
It’s true that many familiar routines are back. But it is also true that things are not exactly the way they were pre-pandemic. And that’s the rub. Going forward, what should medical laboratory managers and pathologists expect to be the “post-pandemic normal” in how patients access care and how providers deliver clinical services? How will healthcare in this country be different from what it was pre-pandemic?
Preparing Clinical Lab Leaders for What Comes Next
These questions and more will be front and center when the Executive War College on Lab and Pathology Management returns on Nov. 2-3, 2021, at the Hyatt Riverwalk Hotel in San Antonio. The theme of this first live gathering since the spring of 2019 will be “Preparing Your Clinical Laboratory and Pathology Group for Post-Pandemic Success.”
“Today, lab managers have the interesting challenge of understanding the new opportunities they can use to advance their labs, both clinically and financially,” stated Robert L. Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report, and founder of the Executive War College. “It isn’t that the pandemic changed healthcare in fundamental ways. Rather, it is that the pandemic accelerated changes that were underway before the outbreak began.
“That’s true of telehealth as well, for example,” he continued. “Once the nation was locked down, utilization of virtual physician visits and telehealth services skyrocketed. Today, national surveys confirm that as many as 50% of all patients and physicians have used a telehealth service, are comfortable with this type of appointment, and are ready to continue to use virtual office visits.
Robert Michel (above), Editor-in-Chief of Dark Daily, its sister publication The Dark Report, and founder of The Dark Intelligence Group, will host the first live edition of the Executive War College since May 2019 in San Antonio. The theme will be “Preparing Your Clinical Laboratory and Pathology Group for Post-Pandemic Success.” Attendees from clinical laboratories and pathology groups will gain critical insights they can act on immediately. (Photo copyright: The Dark Report.)
“Another trend accelerated by the pandemic is patient self-testing at home,” Michel added. “Government health officials saw the benefit of clearing for clinical use different specimen collection systems and COVID-19 test methods designed for use by consumers in the comfort of their home. Today, consumers can choose from multiple specimen collection products and SARS-CoV-2 tests designed for in-home use. Clinical laboratory managers should consider this development to be a consumer home-test baseline. Federal officials have created a regulatory pathway that will make it easier and faster for federal regulators to clear other types of diagnostic tests for consumer home use.”
What if the FDA Approves More Consumer At-Home Tests?
There are implications to each of the two trends described above. In the case of telehealth, if patients see their doctors virtually and the doctors order medical tests, how do clinical laboratories access these patients to collect the specimens needed to do this testing?
Similarly, if, in coming years, the federal Food and Drug Administration (FDA) increases the number of diagnostic test specimen-collection kits that consumers can use from home, how should local clinical laboratories position themselves to receive those kits and perform those tests?
These are two examples of important questions to be answered at sessions scheduled for the Executive War College in San Antonio on Nov. 2-3. Case studies by innovative lab leaders will address topics ranging from high-level strategy to daily management, operations, marketing, and managed care contracting.
Attendance Limited at This Fall’s Executive War College
At the first live edition of the Executive War College since May 2019, attendees will notice one significant difference from earlier years. By design, and for the safety and well-being of attendees, the number of attendees will be limited to 300. The hotel follows the Centers for Disease Control and Prevention (CDC) guidelines and is prepared to adjust those numbers as CDC guidance evolves. Thus, those interested in attending this year’s conference are advised to register early to guarantee their place and avoid being disappointed.
Suggestions for session topics and speakers are welcome and can be sent to info@darkreport.com. Conference details, session topics, and speakers will be updated regularly at www.executivewarcollege.com.
So, register today because seating is limited at the 2021 Executive War College Presents “Preparing Your Clinical Laboratory and Pathology Group for Post-Pandemic Success.” To ensure your place at this valuable conference, click HERE or place this URL (https://dark.regfox.com/2021-ewc-presents) into your browser.
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.
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.)
“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.
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.
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.
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.
