The deal will enable Crosscope’s digital pathology platform to layer around Clarapath’s histology automation hardware, a combination that could improve quality and efficiencies in diagnostic services for future customers, according to a Clarapath press release.
Clarapath’s goal with its products is to automate certain manual processes in histology laboratories, while at the same time reducing variability in how specimens are processed and produced into glass slides. In an exclusive interview with Dark Daily, Eric Feinstein, CEO and President at Clarapath said he believes the resulting data about these activities can drive further changes.
“A histotechnologist turns a microtome wheel and makes decisions about a piece of tissue in real time,” noted Feinstein, who will speak at the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management on April 25-26 in New Orleans. “All of that real-time data isn’t captured. Imagine if we could take all of that data from thousands of histotechnologists who are cutting every day and aggregate it. Then you could start drawing definitive conclusions about best practices.”
“Clarapath’s foundation is about creating consistency and standardizing steps in histology—and uncovering the data that you need in order to accomplish those goals as a whole system,” Eric Feinstein (above), CEO and President at Clarapath told Dark Daily. “A histology lab’s workflow—from when the tissue comes in to when the glass slide is produced—should all be connected.” Many processes in histology and anatomic pathology continue to be manual. Automated solutions can contribute to improved productivity and reducing variability in how individual specimens are processed. (Photo copyright: Clarapath.)
Details Behind Clarapath’s Deal to Acquire Crosscope
As part of its acquisition, Clarapath of Hawthorne, New York, has retained all of Crosscope’s employees, who are located in Mountain View, California, and Bombay, India. Financial terms of the deal were not disclosed.
Clarapath’s flagship histology automation product is SectionStar, a tissue sectioning and transfer system designed to automate inefficient and manual activities in slide processing. The device offers faster and more efficient sample processing while reducing human involvement. Clarapath expects SectionStar be on the market in 2023. The company is currently taking pre-orders.
Meanwhile, Crosscope developed Crosscope Dx, a turnkey digital pathology solution that provides workflow tools and slide management as well as AI and machine learning to assist pathologists with their medical decision-making and diagnoses.
Adoption of Digital Pathology and Automation Can Be Challenging
Digital pathology has experienced growing popularity in the post-COVID-19 pandemic world. This is not only because remote pathology case reviews have become increasingly acceptable to physicians but also because of the ongoing shortages in clinical laboratory staffing.
“A pain point today for clinicians and laboratories is labor. That’s across the board,” Feinstein said. “We can help solve that with SectionStar.”
Feinstein does not believe adoption of digital pathology and histology automation is proceeding slowly, but he does acknowledge barriers to healthcare organizations installing the technologies.
“There are lots of little things that—from a workflow perspective—people have outsized expectations about,” he explained. “Clinicians and administrators are not used to innovating in a product sense. They may be innovating on how they deliver care or treatment pathways, but they’re not used to developing an engineering product and going through alpha and beta stages. That makes adopting new technology challenging.”
Medical laboratory managers and pathologists interested in pursuing histology automation and digital pathology should first determine what processes are sub-optimal or would benefit from the standardization hardware and software can offer. Being able to articulate those gains can help build the case for a return on investment to decision-makers.
Another resource to consider: Feinstein will speak about innovations for remote histology laboratory workers at the upcoming Executive War College for Clinical Laboratory, Diagnostics, and Pathology Management on April 25-26 in New Orleans. His session is titled, “Re-engineering the Classic Histology Laboratory: Enabling the Remote Histotechnologist with New Tools That Improve Productivity, Automate Processes, and Protect Quality.”
Research in the UK and US into how rapid WGS can prevent deaths and improve outcomes for kids with rare genetic diseases may lead to more genetic testing based in local clinical laboratories
Genetic scientists with the National Health Service (NHS) in England have embarked on an ambitious plan to offer rapid whole genome sequencing (rWGS) for children and babies with serious illnesses, as part of a larger initiative to embrace genomic medicine in the United Kingdom (UK).
The NHS estimates that the plan will benefit more than 1,000 children and babies each year, including newborns with rare diseases such as cancer, as well as kids placed in intensive care after being admitted to hospitals. Instead of waiting weeks for results from conventional tests, clinicians will be able to administer a simple blood test and get results within days, the NHS said in a press release.
The press release notes that about 75% of rare genetic diseases appear during childhood “and are responsible for almost a third of neonatal intensive care deaths.”
Here in the United States, pathologists and clinical laboratory managers should see this development as a progressive step toward expanding access to genetic tests and whole genome sequencing services. The UK is looking at this service as a nationwide service. By contrast, given the size of the population and geography of the United States, as this line of medical laboratory testing expands in the US, it will probably be centered in select regional centers of excellence.
“This strategy sets out how more people will be empowered to take preventative action following risk-based predictions, receive life-changing diagnoses, and get the support needed to live with genomically-informed diagnoses alongside improved access to cutting-edge precision [medicine] treatments. It also outlines how the NHS will accelerate future high-quality genomic innovation that can be adopted and spread across the country, leading to positive impacts for current and future generations,” the NHS wrote.
“This global first is an incredible moment for the NHS and will be revolutionary in helping us to rapidly diagnose the illnesses of thousands of seriously ill children and babies—saving countless lives in the years to come,” said NHS chief executive Amanda Pritchard (above) in a press release announcing the program. (Photo copyright: Hospital Times.)
New Rapid Whole Genome Sequencing Service
The NHS announced the plan following a series of trials last year. In one trial, a five-day old infant was admitted to a hospital in Cheltenham, Gloucester, with potentially deadly levels of ammonia in his blood. Whole genome sequencing revealed that changes in the CPS1 gene were preventing his body from breaking down nitrogen, which led to the spike in ammonia. He was given life-saving medication in advance of a liver transplant that doctors believed would cure the condition. Without the rapid genetic test, doctors likely would have performed an invasive liver biopsy.
Using a simple blood test, the new newborn genetic screening service in England is expected to benefit more than 1,000 critically ill infants each year, potentially saving their lives. “The rapid whole genome testing service will transform how rare genetic conditions are diagnosed,” explained Emma Baple, PhD, Professor of Genomic Medicine at University of Exeter Medical School and leader of the National Rapid Whole Genome Sequencing Service in the press release. “We know that with prompt and accurate diagnosis, conditions could be cured or better managed with the right clinical care, which would be life-altering—and potentially life-saving—for so many seriously unwell babies and children,” Precision Medicine Institute reported.
According to The Guardian, test results will be available in two to seven days.
Along with the new rWGS testing service, the NHS announced a five-year plan to implement genomic medicine more broadly. The provisions include establishment of an ethics advisory board, more training for NHS personnel, and an expansion of genomic testing within the existing NHS diagnostic infrastructure. The latter could include using NHS Community Diagnostics centers to collect blood samples from family members to test for inherited diseases.
UK’s Longtime Interest in Whole Genome Sequencing
The UK government has long been interested in the potential role of WGS for delivering better outcomes for patients with genetic diseases, The Guardian reported.
In 2013, the government launched the 100,000 Genomes Project to examine the usefulness of the technology. In November 2021, investigators with the project reported the results of a large pilot study in which they analyzed the genomes of 4,660 individuals with rare diseases. The study, published in the New England Journal of Medicine (NEJM) titled, “100,000 Genomes Pilot on Rare-Disease Diagnosis in Health Care—Preliminary Report,” found “a substantial increase in yield of genomic diagnoses made in patients with the use of genome sequencing across a broad spectrum of rare disease.”
The study’s findings suggest that use of WGS “could save the NHS millions of pounds,” The Guardian reported.
Whole Genome Sequencing System for Newborns in the US
“This NBS-rWGS [newborn screening by rapid whole genome sequencing] system is designed to complement the existing newborn screening process and has the potential to eliminate the diagnostic and therapeutic odyssey that many children and parents face,” Kingsmore said in a press release. “Currently, only 35 core genetic disorders are recommended for newborn screening in the United States, but there are more than 7,200 known genetic diseases. Outcomes remain poor for newborns with a genetic disease because of the limited number of recommended screenings. With NBS-rWGS, we can more quickly expand that number and therefore potentially improve outcomes through precision medicine.”
A more recent 2023 study which examined 112 infant deaths at Rady Children’s Hospital found that 40% of the babies had genetic diseases. In seven infants, genetic diseases were identified post-mortem, and in five of them “death might have been avoided had rapid, diagnostic WGS been performed at time of symptom onset or regional intensive care unit admission,” the authors wrote.
“Prior etiologic studies of infant mortality are generally retrospective, based on electronic health record and death certificate review, and without genome information, leading to underdiagnosis of genetic diseases,” said Christina Chambers, PhD, co-author of the study, in a press release. “In fact, prior studies show at least 30% of death certificates have inaccuracies. By implementing broad use of genome sequencing in newborns we might substantially reduce infant mortality.”
Pioneering work with whole genome sequencing for newborns, such as that being conducted by the clinical laboratory and genetic teams at Rady Children’s Hospital and the UK’s NHS, could allow doctors to make timely interventions for our most vulnerable patients.
High demand for medical laboratory technicians that exists throughout the country motivates some colleges to create training programs to meet this need
Clinical laboratory technicians will be interested to learn that US News and World Report (USNWR) recently ranked their work the 17th Best Healthcare Support Job and 86th of 100 in the magazine’s list of Best Jobs in 2023. The position also ranked “average” in upward mobility and flexibility, but “above average” in stress level. This squares with Dark Daily’s previous reporting on high levels of stress clinical laboratories are still experiencing following the SARS-CoV-2 pandemic.
The median pay, according to USNWR, is $57,800/year and can be as high as $74,530/year. The best paying cities for clinical laboratory technicians are all in California: Redding, Napa, Merced, San Jose, and San Francisco. And the best paying states are New York ($72,500), Rhode Island ($70,580), Connecticut ($70,220), Oregon ($69,330), and California ($68,450).
The graphic above, taken from the US News and World Report’s list of “Best Healthcare Support Jobs in 2023,” illustrates how the base salary for clinical laboratory technicians has risen over the past 10 years. Projections are positive for earnings and availability of clinical laboratory positions continuing to grow around the nation. (Graphic copyright: US News and World Report.)
Clinical Laboratory Technician a Growing Profession
The US News and World Report’s definition of this job drew heavily on the US Bureau of Labor Statistics’ Occupational Outlook Handbook for its description of the position “Clinical Laboratory Technician.” The Labor Department clearly defines the difference between a clinical laboratory “technician” and “technologist” and USNWR carried that over into its analysis.
Accordingly, USNWR described this job category by stating “Clinical laboratory technicians are responsible for a number of tasks, including examining body fluids and cells and matching blood for transfusions. The job requires the use of sophisticated laboratory equipment, such as microscopes and cell counters. With continued advancements in technology, lab work has become more analytical, so laboratory personnel should have excellent judgment skills. More complex procedures are reserved for clinical laboratory technologists, who must possess a bachelor’s degree. Technicians, who must hold at least an associate degree, often work under the supervision of technologists.”
Demand for clinical laboratory technicians spans the country and appears to be increasing.
The program is the result of a local hospital querying Trinity College about implementing just a program.
“It’s been about a year and a half now, getting it up and rolling,” Stephanie Tieso, MS, MLS(ASCP)CM, Program Director Med Lab Sciences, Trinity College, told Quad-City Times. “I know both big hospital systems in the area are very excited about this coming on, and there’s definitely chatter in the lab community about this new program opening.”
Trinity’s program will be the only one of its kind within a 90-mile radius. The initial cohort will consist of 10 students. The Quad-City Times reports “Program majors will earn a Bachelor of Health Sciences degree and qualify to take the MLS certification exam upon program completion and graduation.”
The creation of this program at Trinity College of Nursing and Health Sciences is just one example of programs that could be needed all over the US in the coming years as demand for clinical laboratory workers grows.
Job Outlook Good but Burnout a Possibility
The US Bureau of Labor Statistics’ Occupational Outlook Handbook states, “About 25,600 openings for clinical laboratory technologists and technicians are projected each year, on average, over the decade. Many of those openings are expected to result from the need to replace workers who transfer to different occupations or exit the labor force, such as to retire.” However, the shortage may also be due to the well-reported worker burnout being experienced across the entire healthcare industry which was exacerbated by the SARS-CoV-2 pandemic.
This ebrief follows the story of Susanna Bator, a former clinical laboratory technician with the Cleveland Clinic and with MetroHealth System in Cleveland, Ohio. Bator shared her story of working in various laboratories during the coronavirus pandemic in an essay she wrote for Daily Nurse titled, “The Hidden Healthcare Heroes: A Lab Tech’s Journey Through the Pandemic.” Bator’s essay is a personalized, human look at the strain clinical laboratory technicians were put under during the pandemic. Her story presents the quandary of how to keep these critical frontline healthcare workers from experiencing burnout and leaving the field.
“We techs were left unsupported and unmentored throughout the pandemic. No one cared if we were learning or growing in our job, and there was little encouragement for us to enter training or residency programs. We were just expendable foot soldiers: this is not a policy that leads to long-term job retention,” she wrote.
This validates US News and World Report’s statistic that the work of clinical laboratory technicians comes with an “above average” level of stress. For those who can handle it, however, the job has many benefits and provides multiple opportunities for growth.
But the burnout Bator and other techs encountered is very real. Hopefully more training programs like the one at Trinity College will become available to provide the learning and support lab techs need as we move into post-pandemic healthcare. As the US News and World Report article shows, clinical laboratory technicians are filling a critical need in the laboratory industry and new training programs will be instrumental to their success.
Though smartphone apps are technically not clinical laboratory tools, anatomic pathologists and medical laboratory scientists (MLSs) may be interested to learn how health information technology (HIT), machine learning, and smartphone apps are being used to assess different aspects of individuals’ health, independent of trained healthcare professionals.
The issue that the Cedars Sinai researchers were investigating is the accuracy of patient self-reporting. Because poop can be more complicated than meets the eye, when asked to describe their bowel movements patients often find it difficult to be specific. Thus, use of a smartphone app that enables patients to accurately assess their stools in cases where watching the function of their digestive tract is relevant to their diagnoses and treatment would be a boon to precision medicine treatments of gastroenterology diseases.
“This app takes out the guesswork by using AI—not patient input—to process the images (of bowel movements) taken by the smartphone,” said gastroenterologist Mark Pimentel, MD (above), Executive Director of Cedars-Sinai’s Medically Associated Science and Technology (MAST) program and principal investigator of the study, in a news release. “The mobile app produced more accurate and complete descriptions of constipation, diarrhea, and normal stools than a patient could, and was comparable to specimen evaluations by well-trained gastroenterologists in the study.” (Photo copyright: Cedars-Sinai.)
Pros and Cons of Bristol Stool Scale
In their paper, the scientists discussed the Bristol Stool Scale (BSS), a traditional diagnostic tool for identifying stool forms into seven categories. The seven types of stool are:
Type 1: Separate hard lumps, like nuts (difficult to pass).
Type 2: Sausage-shaped, but lumpy.
Type 3: Like a sausage, but with cracks on its surface.
Type 4: Like a sausage or snake, smooth and soft (average stool).
Type 5: Soft blobs with clear cut edges.
Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea).
Type 7: Watery, no solid pieces, entirely liquid (diarrhea).
But even with the BSS, things can get murky for patients. Inaccurate self-reporting of stool forms by people with IBS and diarrhea can make proper diagnoses difficult.
“The problem is that whenever you have a patient reporting an outcome measure, it becomes subjective rather than objective. This can impact the placebo effect,” gastroenterologist Mark Pimentel, MD, Executive Director of Cedars-Sinai’s Medically Associated Science and Technology (MAST) program and principal investigator of the study, told Healio.
Thus, according to the researchers, AI algorithms can help with diagnosis by systematically doing the assessments for the patients, News Medical reported.
30,000 Stool Images Train New App
To conduct their study, the Cedars-Sinai researchers tested an AI smartphone app developed by Dieta Health. According to Health IT Analytics, employing AI trained on 30,000 annotated stool images, the app characterizes digital images of bowel movements using five parameters:
BSS,
Consistency,
Edge fuzziness,
Fragmentation, and
Volume.
“The app used AI to train the software to detect the consistency of the stool in the toilet based on the five parameters of stool form, We then compared that with doctors who know what they are looking at,” Pimentel told Healio.
AI Assessments Comparable to Doctors, Better than Patients
According to Health IT Analytics, the researchers found that:
AI assessed the stool comparable to gastroenterologists’ assessments on BSS, consistency, fragmentation, and edge fuzziness scores.
AI and gastroenterologists had moderate-to-good agreement on volume.
AI outperformed study participant self-reports based on the BSS with 95% accuracy, compared to patients’ 89% accuracy.
Additionally, the AI outperformed humans in specificity and sensitivity as well:
Specificity (ability to correctly report a negative result) was 27% higher.
Sensitivity (ability to correctly report a positive result) was 23% higher.
“A novel smartphone application can determine BSS and other visual stool characteristics with high accuracy compared with the two expert gastroenterologists. Moreover, trained AI was superior to subject self-reporting of BSS. AI assessments could provide more objective outcome measures for stool characterization in gastroenterology,” the Cedars-Sinai researchers wrote in their paper.
“In addition to improving a physician’s ability to assess their patients’ digestive health, this app could be advantageous for clinical trials by reducing the variability of stool outcome measures,” said gastroenterologist Ali Rezaie, MD, study co-author and Medical Director of Cedars-Sinai’s GI Motility Program in the news release.
The researchers plan to seek FDA review of the mobile app.
Opportunity for Clinical Laboratories
Anatomic pathologists and clinical laboratory leaders may want to reach out to referring gastroenterologists to find out how they can help to better serve gastro patients. As the Cedars-Sinai study suggests, AI smartphone apps can perform BSS assessments as good as or better than humans and may be useful tools in the pursuit of precision medicine treatments for patient suffering from painful gastrointestinal disorders.
Novel scheme by medical laboratory company to induce patients to collect and return their own specimen for testing is central to a federal whistleblower case alleging violations of the Anti-Kickback Statute
Handing out gift cards only to patients who return a specimen to a clinical laboratory company for colorectal cancer screening is a unique approach that is now at the center of a federal qui tamcase filed by a retired Indiana pathologist.
The defendant in this whistleblower lawsuit is Exact Sciences Laboratories and its parent company Exact Sciences Corporation (NASDAQ:EXAS). Last month, a federal judge ruled the court case will proceed following attempts by the defendant’s attorneys to have the case dismissed.
The plaintiffs (United States of America ex rel. Niles Rosen, MD) allege Exact Sciences Laboratories violated the Federal Anti-Kickback Statute (AKS) and False Claims Act by offering $75 gift cards to induce patients to return self-collected fecal samples for the lab’s Cologuard at-home colon cancer screening kit through its Patient Compliance Program.
Exact Sciences refuted the allegations and moved to have the case dismissed claiming it “had a good faith belief that its [Patient Compliance Program] complied with the law and thus lacked the requisite intent for a violation of the AKS,” according to court documents. The court denied Exact Sciences’ motion to dismiss.
“We are grateful for the hard work and courage of those private citizens who bring evidence of fraud to the Department’s attention, often putting at risk their careers and reputations,” said Brian Boynton, JD (above), Principal Deputy Assistant Attorney General and head of the federal Department of Justice (DOJ) Civil Division in a February 7, 2023, DOJ statement. “Our ability to protect citizens and taxpayer funds continues to benefit greatly from their actions.” Clinical laboratory managers will want to follow this and other qui tam cases claiming violation of anti-kickback laws. (Photo copyright: Department of Justice.)
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Was Exact Sciences’ Patient Compliance Program a Kickback?
Cologuard is a non-invasive testing kit utilized by people to screen for colorectal cancer in the privacy of their own homes. It is intended for those over the age of 45 who are at low or average risk for the disease. Exact Sciences regularly runs television advertisements urging individuals to be screened for colorectal cancer using the Cologuard test.
Following a physician’s order, and after receiving the testing kit in the mail, individuals collect a stool sample using the specimen container in the kit and return the sample to Exact Sciences Laboratories (ESL) for analysis. The test works by looking for certain DNA markers and blood in the stool sample.
According to Report on Medicare Compliance from the Health Care Compliance Association (HCCA), in 2017, a gastroenterologist ordered the Cologuard kit for Rosen, the whistleblower, but Rosen chose not to return a stool sample to ESL. A few months later, ESL sent Rosen a letter offering him a $75 Visa gift card if he performed the at-home specimen collection and then returned it to ESL by March 22, 2018. Persuaded by the offer, Rosen collected a sample, returned it to ESL, and received the gift card.
As part of its Patient Compliance Program, ESL analyzed Rosen’s sample and received $499 from Medicare for performing the test. The complaint filed against Exact Sciences states Medicare paid Exact Sciences more than $160 million for a total of 334,424 Cologuard tests in 2018 while the company offered “unlawful cash equivalent inducements directly to Medicare beneficiaries,” COSMOS reported.
“It was a straight-up kickback,” Rosen’s attorney Marlan Wilbanks, JD, Senior Partner at Atlanta law firm Wilbanks and Gouinlock, told COSMOS. “You can’t offer cash or cash equivalents to anyone to induce them to use a government service.”
DOJ Elects to Not Intervene in Lawsuit
In February 2020, Exact Sciences received a civil investigation demand by the US Department of Justice (DOJ) regarding the gift card incentive. The DOJ later filed a notice that it had elected to decline intervention in the lawsuit. This action did not prevent Rosen from continuing with the lawsuit. Accordingly, in April of 2021, he filed an amended complaint against Exact Sciences alleging violations of the Federal Anti-Kickback Statute and False Claims Act.
Rosen is seeking a monetary award for himself, and on behalf of the US government, for civil penalties, treble damages, fees, and costs.
According to Report on Medicare Compliance, Exact Sciences “refuted the allegations and asserted, among other things, that the arrangement qualifies for the preventive care safe harbor to the anti-kickback statute (AKS) and that the complaint fails for many reasons.”
Exact Sciences also noted in its motion to dismiss that “encouraging a patient to have a medical service that was already ordered by a provider isn’t an inducement under the AKS.”
At this time, the case remains unresolved and continues in federal court.
DOJ Recovers Billions of Taxpayer Dollars from AKS Violations
A qui tam lawsuit or action is a method available for individuals to help the government circumvent fraud and recover money for taxpayers. Types of fraud included in these cases often pertain to Medicare and Medicaid services, defense contractor fraud, and procurement fraud.
According to the DOJ, over $1.9 billion was recovered as a result of qui tam lawsuits pursued by either the government or whistleblowers during fiscal year 2022. The number of these types of lawsuits has increased dramatically over the years with a total of 652 qui tam cases filed in 2022 alone.
Thus, clinical laboratory professionals should be aware that this type of novel scheme to generate more patients could possibly lead to legal issues. Dark Daily would like to credit Laboratory Economics for calling attention to this fascinating case of alleged illegal inducement involving a medical laboratory company.
