Labcorp, the commercial laboratory giant headquartered in Burlington, N.C., has billions of diagnostic test results archived. It takes samplings of those results and runs them through a machine learning algorithm that compares the data against a condition of interest, such as chronic kidney disease (CKD). Machine learning is a subdiscipline of AI.
Based on patterns it identifies, the machine learning algorithm can predict future test results for CKD based on patients’ testing histories, explained Stan Letovsky, PhD, Vice President for AI, Data Sciences, and Bioinformatics at Labcorp. Labcorp has found the accuracy of those predictions to be better than 90%, he added.
Labcorp also has created an AI-powered dashboard that—once layered over an electronic health record (EHR) system—allows physicians to configure views of an individual patient’s existing health data and add a predictive view based on the machine learning results.
For anatomic pathologists, this type of setup can quickly bring a trove of data into their hands, allowing them to be more efficient with patient diagnoses. The long-term implications of using this technology are significant for pathology groups’ bottom line.
Stan Letovsky, PhD (above), Vice President for AI, Data Sciences, and Bioinformatics at Labcorp, discussed AI developments in digital pathology during his keynote address at the 2022 Executive War College in New Orleans. “The best thing as a community that we can do for patients and their physicians with AI is to identify care gaps early on,” he said, adding, “If pathologists want to grow and improve their revenue, they have to be more productive.” (Photo copyright: Dark Intelligence Group).
Mayo Clinic Plans to Digitize 25 Million Glass Slides
In other AI developments, Mayo Clinic in Rochester, Minn., has started a project to digitally scan 25 million tissue samples on glass slides—some more than 100 years old. As part of the initiative, Mayo wants to digitize five million of those slides within three years and put them on the cloud, said pathologist and physician scientist Jason Hipp, MD, PhD, Chair of Computational Pathology and AI at Mayo Clinic.
“We want to be a hub within Mayo Clinic for digital pathology,” Hipp told Executive War College attendees during his keynote address.
Hipp views his team as the bridge between pathologists and the data science engineers who develop AI algorithms. Both sides must collaborate to move AI forward, he commented, yet most clinical laboratories and pathology groups have not yet developed those relationships.
“We want to embed both sides,” Hipp added. “We need the data scientists working with the pathologists side by side. That practical part is missing today.”
The future medical laboratory at Mayo Clinic will feature an intersection of pathology, computer technology, and patient data. Cloud storage is a big part of that vision.
“AI requires storage and lots of data to be practical,” Hipp said.
27th annual meeting of medical laboratory and pathology managers delivers insights on the path ahead for diagnostics, ranging from the supply chain shortage and the ‘Great Resignation’ to advances in artificial intelligence and whole genome sequencing in service of precision medicine
What’s coming as healthcare providers move to post-COVID-19 pandemic workflows will be of keen interest to clinical laboratory leaders attending this critical event. Several new and dynamic market changes are reshaping the development of, ordering, and reimbursement for medical laboratory tests. They include:
Millennials as change agents in how care is accessed and delivered.
New buyers of large volumes of clinical lab tests, such as retail pharmacies.
How clinical laboratories can earn new sources of revenue while supporting precision medicine.
Clinical Labs Should Prepare for the ‘Coming Roller Coaster Ride’
Robert L. Michel, Editor-in-Chief of Dark Daily’s sister publication, The Dark Report, and Founder of the Executive War College, described the “coming roller coaster ride” for the pathology and clinical laboratory industries.
Amid the usual operational issues labs deal with (e.g., workforce shortages, supply chain disruptions, regulatory pressures), he noted the emergence of new and powerful forces pulling clinical laboratories and pathology groups in all directions.
“One primary factor is how Millennials will use healthcare differently than Gen Xers and Baby Boomers,” Michel noted. “Similarly, Millennials will make up 75% of the pathologists and the lab workforce by 2025.
“Another major force for change will be new buyers of clinical laboratory tests,” he continued. “For example, expect to see national retail pharmacy chains build thousands of primary care clinics in their retail pharmacies. These clinics will need lab tests and will become major buyers of near-patient analyzers and lab tests.
“A third interesting factor is that a new class of in vitro diagnostics (IVD) manufacturers are developing analyzers and test systems that use minimal amounts of specimens and return answers in minutes. Primary care clinics in retail pharmacies will be interested in buying these lab testing solutions,” Michel concluded.
Robert L. Michel (above), Editor-in-Chief of The Dark Report and Founder of the Executive War College, has studied and worked with leaders of clinical laboratories and pathology groups for more than four decades. During his keynote address, he predicted that powerful economic forces are about to be unleashed on the traditional market for clinical laboratory testing. Those forces include the use of artificial intelligence (AI) in digital pathology, primary care in retail pharmacies, and increased focus on precision medicine. (Photo copyright: The Dark Intelligence Group.)
Peer-to-Peer Learning Opportunities
With approximately 90 presenters scheduled, clinical laboratory leaders from such prestigious institutions as Johns Hopkins Hospital, Mayo Clinic, United Indian Health Services, and more will facilitate peer-to-peer learnings throughout the conference.
In addition, several sessions and panel Q/A discussions will cover critical legal and regulatory issues and payer challenges facing the industry.
New Technologies, Workflows, Analytics
The 2022 Executive War College master classes, breakouts, panel discussions, and benefactor sessions will highlight several significant themes:
Lab data analytics and utilization. Sessions this year are heavily weighted toward data analytics, aggregation, and utilization. Look for case studies demonstrating the value of lab data, and where and how data has become actionable and monetized. As Dark Daily previously reported, useful data structures have been difficult to achieve for clinical laboratories; however, the case studies featured during this week’s conference will demonstrate signs of progress and highlight lessons learned.
Automation. Several case studies are planned that focus on expansion and modernization using laboratory automation. From Butler Health System, an independent hospital system in western Pa., Robert Patterson, MD, Medical Director of Pathology, Laboratory Medicine, and Laboratory Outreach, will detail steps Butler took that enabled its labs to better compete with other area health systems and national reference laboratories. Likewise, Eric Parnell, System Supervisor of Microbiology for Bronson Healthcare in southern Mich., will discuss his lab’s transition to and implementation of total laboratory automation.
Genetic testing and next-generation sequencing (NGS). Quickly becoming the foundational disruptor technology on which many new and powerful clinical laboratory tests and procedures are based, genomic testing has now become accessible and affordable. Many clinical laboratories and pathology groups are using molecular diagnostics testing to deliver clinical value to referring physicians.
Other sessions include:
Launching and scaling clinical NGS testing in a clinical environment (featuring a project at Rady Children’s Hospital in San Diego).
How labs and payers can work together to achieve better outcomes and health equity using genomic testing.
Effective ways to repurpose PCR and other genetic test instruments to build specimen volume and increase lab revenue.
Paths Forward for Clinical Labs and Pathology Groups
Another important topic being discussed at the 2022 Executive War College is how to position clinical laboratories and pathology groups for the next phase of modern healthcare.
Attracting capital for clinical labs and pathology groups.
Emerging concepts in growth strategies.
Business valuation factors.
Unexpected disruptions during sales closings.
These are just a few highlights of the informative sessions and expert speakers scheduled during this week’s 27th annual Executive War College in New Orleans. Look for more coverage in Dark Daily during the days ahead and in upcoming editions of our sister publication The Dark Report.
Full details about the 2022 Executive War College can be found by clicking on this link. (Or copy/paste this URL into your web browser: http://www.executivewarcollege.com.)
Speakers, session topics, and the conference agenda can be viewed by clicking on this link. (Or copy/paste this URL into your web browser: https://executivewarcollege.darkintelligencegroup.com/executive-war-college-agenda-2022.)
Book provides detailed road map for clinical laboratory professionals who believe they have a valid case to file under the federal qui tam statute, as well as lab owners who want to understand what motivates whistleblowers and what practices to avoid
Several high-profile whistleblower cases uncovering massive fraud have shocked the clinical laboratory industry over the past decade. Media coverage nearly always focuses on the court battle and subsequent renderings of justice. But little is written about what it is like to be a whistleblower who wants to hold a medical laboratory accountable for alleged violations of federal and state laws.
Now, a new “tell-all” book penned by Chris Riedel, a whistleblower who owned a clinical laboratory company in California, details the exploits of clinical laboratory whistleblowers over the past 15 years. The intriguing white-collar crime thriller, titled, “Blood Money: One Man’s Bare-Knuckle Fight to Protect Taxpayers from Medical Fraud,” outlines Riedel’s battle with major clinical laboratory players—including the so-called “Blood Brothers” Labcorp (NYSE:LH) and Quest Diagnostics (NYSE:DGX)—to expose medical laboratory fraud.
‘Most Whistleblowers Get Absolutely Destroyed’
The book takes the reader on a gripping journey into extortion, money laundering, attempted murder, buried gold in a CEO’s backyard, fraudsters hiding money in the Cayman Islands, and, according to the author, an Assistant Attorney General sabotaging her own state’s case and a corrupt state Governor who undermined litigation by his own Attorney General.
“I wrote it to be a true crime thriller, so I’m hoping people who love thrillers will enjoy it as a true crime story,” Riedel said in an exclusive interview with Dark Daily. “For anyone who’s considering filing a whistleblower lawsuit, this is an absolute must read.
“Most whistleblowers get absolutely destroyed,” he explained. “When companies find out who’s trying to attack their business model, they do everything they can to destroy the whistleblower’s life. Many end up bankrupt, unemployable, and divorced.
“There are things you can do to protect yourself and I list those in my rules for whistleblowers. I hope enough people will read it—particularly in Congress and maybe the Department of Justice (DOJ)—to put pressure on the DOJ to change their behavior. They are far too willing to accept what they call ‘affordable civil settlements’ as opposed to punishing companies and people for their theft,” Riedel said.
Chris Riedel (above) has worked in the healthcare industry as an executive and an entrepreneur for more than 40 years. He founded five companies, including two medical laboratories and a cardiovascular disease management company. For the past 15 years, he has been tirelessly working to fight against medical companies that are defrauding US taxpayers. His actions have resulted in a court verdict and settlements totaling more than $550 million. (Photo copyright: Leadership Books.)
Riedel became a whistleblower in 2005 when he filed a case under California law that was sealed until 2009. Jerry Brown, California Attorney General at that time, joined the case and unsealed it.
Riedel had acted after his sales representatives informed him that his company, Hunter Laboratories, needed to come up with a way to compete against larger labs’ pricing to survive. Knowing the test-price-discounting practices transpiring within the lab industry in California, Riedel determined he had three choices:
Violate federal and state laws to compete,
Close his business, which would cause him to lay off more than 150 employees and lose most of his life’s savings, or
Try to stop the other companies from participating in fraudulent practices.
“It is very frustrating for honest CEOs of clinical labs to see that they cannot compete well against those lab companies employing fraudulent schemes. Rather than compete on the quality of service of their products as honest companies do, fraudsters compete based on the value of their illegal inducements,” he states on his website. “I felt the pain that many other honest CEO’s and lab owners have had to endure as they try to compete with fraud and watch their life’s work destroyed.”
He chose to try leveling the playing field for all labs and stop taxpayers from being fleeced. After filing that first whistleblower lawsuit in California in 2005, he later filed similar whistleblower lawsuits in other states that had statutes defining how labs were to price lab tests for their Medicaid programs.
Riedel encountered many roadblocks and frustrations during the initial lawsuit, including some genuinely frightening moments. He described one such experience for Dark Daily.
“Quest and Labcorp together went to Blue Shield of California, a major insurance company, and they got our clinical lab kicked out of network. They offered Blue Shield a 10% discount on all their laboratory testing if they would kick Hunter Laboratories out of network,” Riedel explained. “Since [Quest and Labcorp] represented about 70% to 80% of the total outpatient laboratory testing for Blue Shield, it was too good for this insurer to pass up.
“When your lab loses a major insurance carrier like that, you can’t survive. What doctor is going to want to start with a clinical lab that doesn’t have Blue Shield? And existing clients don’t want to subject their patients to having much higher out-of-pocket expenses.
“From that point on, it was like a dagger in our heart,” he added. “We were literally two weeks away from both corporate and personal bankruptcy when we reached our historic settlement with Quest. Had it not been for that settlement, our 150 employees would have lost their jobs, we would have lost our house, and we would have been completely bankrupt. That was very scary, and I had a very hard time dealing with it.”
Uncovering Medical Laboratory Fraud
While performing his research for the whistleblower case, Riedel was astonished by the information and fraud he discovered.
“There was one point where we had to prove that Quest and Labcorp were passing out discounts to some clients that were at or below cost, without giving those same prices to the Medi-Cal program, as required by state law at that time,” Riedel explained. “I personally reviewed over a million documents. It took more than five years, but it was worth it.
“I eventually found three documents that exposed the complete fraud by Quest. These documents showed what Quest had billed Medi-Cal, how much money the company lost client billing and capitation contracts, and how much business they ‘pulled through’ from the government and insurance payers that made up for the staggering losses on deeply discounted client and capitated billing. That was like the silver bullet.”
In the process, Riedel also discovered what it was like to work with the federal Department of Justice.
“The DOJ hates people who file more than one whistleblower lawsuit,” he added. “They don’t like the statute to begin with, and they barely tolerate whistleblowers, so when they find someone who does it time and again, they really don’t like it.”
“Blood Money” (above) contains practical advice and suggestions that are useful for both clinical laboratory executives and pathologists who want to keep their lab operations compliant with federal law, thus not giving whistleblowers any issues to pursue a qui tam lawsuit, as well as lab whistleblowers who observe violations within their clinical labs—or at competing labs—and who want to do something that may rectify the situation. (Photo copyright: Chris Riedel.)
Riedel is considering writing a second book and is trying to decide which qui tam lawsuits will provide the best subject matter.
“I am currently investigating what would be a multi-billion-dollar lawsuit against an insurance company and that is going to be, by far, the biggest of the cases I have ever been involved in. That might make a good book all by itself,” he said.
Riedel finds his work fighting fraud against the government rewarding and plans to continue his efforts in the future.
“Even though it’s risky—and the book details how my life was almost destroyed when the Blood Brothers counter attacked—I enjoy the investigative work and legal challenges. For me, it is very fulfilling, and I am proud to carry the torch for taxpayers,” he says in a statement on his website.
The 368-page book should be of interest to clinical laboratory personnel, healthcare professionals, those considering becoming a whistleblower, and basically anyone involved in medical laboratory testing.
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.
Though clinical laboratory RT-PCR tests remain the ‘gold standard’ when diagnosing COVID-19, at-home antigen tests offer convenience and quick test results. But are they accurate?
Clinical laboratory and pathologists generally acknowledge that RT-Polymerase Chain Reaction (RT-PCR) tests remain the preferred method for detecting COVID-19 disease. However, according to Popular Science, rapid at-home antigen tests that accurately identify people carrying larger loads of the virus are becoming important tools in the fight against spread of the coronavirus.
DxTerity SARS-CoV-2: This saliva-based collection kit is available on Amazon and at Walmart for $110. Specimens must be sent via FedEx on the same day as collection. Results are available within 24 to 72 hours of the sample being received by the PCR testing lab.
Lucira Check It COVID-19 Test Kit: Billed as offering “PCR quality molecular accuracy,” this nasal swab test costs $55 and provides results in 30 minutes or less.
Abbott BinaxNOW Antigen Self-Test. Results within 15 minutes and available for $23.99 at major pharmacies. Each box includes two nasal swab tests, with the second test taken within 36 hours of the first.
Pixel COVID-19 At-Home Collection Kit: This nasal-swab-based mail-in collection kit is available online for $119. Results delivered within 24 to 48 hours of the sample being received by Labcorp.
Many of the newest at-home tests not only have users collect their own swab or saliva samples, but some also provide results in less than an hour, which can be sent to the user’s smartphone. Conversely, home-based collection kits that are returned to clinical laboratories for testing can take 48 hours or longer for shipping and processing.
The FDA’s emergency use authorization announcement (EUA) for Ellume’s $38.99 COVID-19 At Home Test (above) states the test “is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual two years of age or older.” Ellume’s self-collection test was the first such test to receive an FDA EUA for use without a physician’s order. (Photo copyright: Ellume).
Among the issues cited were the potential for inadequate samples and improper handling to cause inaccurate results, as well as uncertainty whether at-home antigen tests will pick up on COVID-19 variants.
At-home tests also are less likely to be covered by insurance, MedPage Today reported.
During the CAP virtual media briefing, pathologist Kalisha Hill, MD (above), Chief Medical Officer and Chair, Department of Pathology and Medical Director, Laboratory Services, at AMITA Health St. Mary’s Kankakee (Ill.), said, “The gold standard is still a laboratory-performed real-time PCR test and that is the most sensitive and most accurate that we do that is very specific for COVID-19.” Hill called at-home tests a “good screening tool,” but she noted, “You’re testing that moment, that day, and as soon as you leave your home or come in contact with someone else, you could potentially be COVID positive. It’s also important to recognize that when you’re collecting a sample yourself, you may not be able to obtain enough sample for an accurate result … It’s very important how it is collected and also the sensitivity and specificity of the test,” she added. (Photo copyright: AMITA Health/LinkedIn.)
How Do the Tests’ Accuracy Compare?
The Quest Direct and LabCorp Pixel tests—both of which are sent to company labs for PCR testing—scored highest on the two main statistical measures of performance sensitivity (positive percent agreement) and specificity (negative percent agreement). According to Popular Science, each of these tests’ sensitivities and specificities are close to 100%.
According to the websites of the other tests reviewed by Popular Science:
DxTerity test, which uses a saliva sample—97.2% sensitivity and a 92.5% specificity.
BinaxNOW test—84.6% sensitivity and 98.5% specificity.
Cue COVID-19 test—98.7% sensitivity and 97.6% specificity.
Lucira Check Its test—98% accuracy.
Ellume test—95% sensitivity and 97% specificity.
Rapid Antigen Tests Accurate and Easy to Use, says Popular Science
Popular Science found the tests generally easy to use and concluded they are a beneficial—if imperfect—tool in the fight against COVID-19.
“If you’re unvaccinated and symptomatic, they’re a great way to confirm a COVID-19 infection without risking a trip out of the house,” Popular Science stated in its article. “If you’re unvaccinated and have no symptoms, and just want to know whether you can safely attend a family dinner or soccer game, an at-home test remains an imperfect way of self-screening. Remember: If the test comes back negative, there’s still the chance the result is false, and you could accidentally expose others by being within six feet of them without a mask on.”
As the popularity of at-home COVID-19 tests increases, clinical laboratories that perform RT-PCR tests may want to keep a watchful eye on the demand for at-home rapid antigen testing, especially now that some tests are available without prescription.
