By partnering with drug manufacturers to connect customers with clinical trials, the retail pharmacy chain believes this new venture will be the company’s “next growth engine.”
Walgreens is launching a business to connect customers with clinical drug trials, a venture that adds another offering to the retail pharmacy giants’ growing menu of healthcare services. This new venture might also mean additional test orders for clinical laboratories and pathology groups in areas that serve Walgreens customers.
Now, Walgreens is attempting to further redefine the patient experience by partnering with pharmaceutical companies to find participants for clinical trials, a business that could result in more Americans from underrepresented racial and ethnic populations enrolling in drug-development trials. With 9,021 retail pharmacies in all 50 states, it is well-positioned to know which of its customers would be candidates for different clinical trials.
“Walgreens’ trusted community presence across the nation, combined with our enterprise-wide data and health capabilities, enables us to pioneer a comprehensive solution that makes health options, including clinical trials, more accessible, convenient and equitable,” said Ramita Tandon, Walgreens’ Chief Clinical Trials Officer, in a press release.
Ramita Tandon, Walgreens’ Chief Clinical Trials Officer, believes Walgreens can play a role in solving the issues of diversity and declining enrollment in clinical trials. “Through the launch of our clinical trials services, we can provide another offering for patients with complex or chronic conditions in their care journey, while helping sponsors advance treatment options for the diverse communities we serve,” she said in a press release. (Photo copyright: Walgreens.)
Serving the Socially Vulnerable
In an interview with Fierce Healthcare, Tandon described the clinical trials business as Walgreens’ “next growth engine” of consumer-centric healthcare solutions.
According to the company press release, “Walgreens is addressing access barriers through a compliant, validated and secure decentralized clinical trial platform built on a rigorous compliance and regulatory framework to ensure patient privacy and security. This approach leverages owned and partner digital and physical assets, including select Health Corner and Village Medical at Walgreens locations, to directly engage patients at home, virtually or in-person.”
Walgreens notes that more than half of its roughly 9,000 U.S.-based stores are in “socially vulnerable areas.”
According to the Washington Examiner, a US Food and Drug Administration (FDA) study revealed that 75% of patients who participate in clinical trials are white, while just 11% are Hispanic and fewer than 10% are Asian or black. In addition, participation in clinical trials has been declining, with 80% of trials failing to attract enough participants on time.
Tandon maintains that making the process of participating in clinical trials easier is another key to increasing diversity and participation in clinical trials.
“During the clinical trial journey, we know it’s a burden for patients to visit sites. We also know that 78% of patient-consumers in the US live within five miles of a Walgreens,” she told PharmaVoice. “If a patient can complete much of the up-front clinical trial requirements at a local Walgreens, or conduct some of the visits digitally, it would make the whole clinical trial experience that much more positive and, maybe, encourage the patient to participate in new clinical trials going forward.”
Walgreens also plans to use its treasure-trove of customer data to find potential patients for its trials business.
“Understanding this detail of customer preference and segmentation can be quite useful particularly in clinical trials, for example, to create better protocols,” Tandon told PharmaVoice. “We are sitting on so much information, but we can, and need to, do a better job of using these insights in a real-world setting, which can be translated to pharma R/D or brand management organizations. We’re all about patient-centric drug development.”
FDA Seeks Diversity in Clinical Trails
Walgreens is in discussions with several drug manufacturers as it looks to launch this new venture.
“We are working very closely with them to understand their business needs and create the solution that’s going to be sort of bespoke to their specific trial needs,” Tandon told Fierce Healthcare. “Our goal is to move that needle and start to see a larger number of US patients participating and highly diverse participants that are coming into clinical trials.”
In April, an FDA press release announced new draft guidance aimed at “developing plans to enroll more participants from underrepresented racial and ethnic populations in the US into clinical trials.”
“Despite having a disproportionate burden for certain diseases, racial and ethnic minorities are frequently underrepresented in biomedical research,” the FDA stated. “Clinical trials provide a crucial base of evidence for evaluating whether a medical product is safe and effective; therefore, enrollment in clinical trials should reflect the diversity of the population that is ultimately going to use the treatment.”
Disintermediation of Retail Pharmacies
“Walgreens has a significant opportunity to create an interconnected healthcare ecosystem where we can use the physical assets of Walgreens and connect with patients and consumers at a local level to better support healthcare and healthcare equality,” Tandon said in PharmaVoice.
This is the latest example of a billion-dollar retail pharmacy chain diversifying away from simply filling prescriptions. Two types of competitors are driving the disintermediation of retail pharmacies because they end up directing patients away from the pharmacy:
Amazon.com acquired PillPack and now sends, via mail, prescriptions to patients’ homes.
Pharmacy benefit management (PBM) companies with a business model that encourage patients to get 90 days of prescriptions at once, mailed to their home.
In both cases, retail pharmacies lose access to patients. This is what is motivating several national pharmacy chains to offer primary care within their retail pharmacies (where following an office visit with a general practitioner, the patient simply crosses the store to the pharmacy to fill his/her prescription), as well as the clinical trial matching business.
As retail pharmacy chains become an increasingly disruptive force in healthcare, clinical laboratory managers and pathologists should be preparing new strategies to meet the testing needs of a changing primary care delivery model, which likely will include lab testing being offered in nontraditional medical locations.
InspectIR COVID-19 Breathalyzer identifies a chemical signature associated with SARS-CoV-2 in about three minutes with 91.2% sensitivity and 99.3% specificity
One company is hoping that it can make breathalyzers a viable, easier way to screen for SARS-CoV-2. It will soon have the opportunity to learn if consumers will accept this form of screening for COVID-19, as its device recently obtained an Emergency Use Authorization from the FDA.
On April 14, 2022, InspectIR Systems, LLC, of Frisco, Texas, was granted the US Food and Drug Administration’s first-ever emergency use authorization (EUA202006) for a portable breath test device designed to screen for SARS-CoV-2 infection. Clinical laboratories that perform COVID-19 testing will want to compare the high-level sensitivity of this breath test compared to rapid antigen tests currently used for COVID-19 screening.
The device is about the size of a carry-on suitcase. It provides test results in less than three minutes and is currently authorized for use with subjects who are 18 or older.
The FDA’s EUA limits use of the device to “a qualified, trained operator under the supervision of a healthcare provider licensed or authorized by state law to prescribe tests,” the federal agency said. The test “can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals, and mobile testing sites.”
The InspectIR COVID-19 Breathalyzer device “is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeffrey Shuren, MD, JD (above), director of the FDA’s Center for Devices and Radiological Health (CDRH), in the news release. A portable device that can identify SARS-CoV-2 infections in a few minutes with 91% specificity may be of great interest to clinical laboratory companies operating COVID-19 popup testing sites around the nation. (Photo copyright: US Food and Drug Administration.)
In granting the authorization, the FDA cited results of a study with 2,409 participants in which the test had sensitivity (correct positive results) of 91.2% and specificity (correct negative results) of 99.3%. “The test performed with similar sensitivity in a follow-up clinical study focused on the Omicron variant,” the agency stated.
“The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the US for the next public health emergency,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health (CDRH), in the news release.
In its coverage of the EUA, CNET noted that the InspectIR breath test is more sensitive than rapid antigen tests but not as sensitive as PCR tests. The FDA advised that people who receive a positive test result with the InspectIR COVID-19 Breathalyzer should follow up with a PCR molecular test.
How the InspectIR COVID-19 Breathalyzer Works
InspectIR LLC was founded in 2017 by Tim Wing and John Redmond, Forbes reported. Their original goal was to develop a breathalyzer for detection of cannabis or opioid use. However, with the onset of the COVID-19 pandemic, the entrepreneurs decided to adapt the technology into a SARS-CoV-2 diagnostic test.
As described in the FDA’s EUA documents, a subject breathes into the device using a sterilized one-time-use straw. A pre-concentrator collects and concentrates the five targeted VOCs, all from the ketone and aldehyde families of organic compounds. These go to a Residual Gas Analyzer, and an algorithm determines whether the sample contains the chemical signature associated with a SARS-CoV-2 infection.
Redmond told Forbes that the specific mix of VOCs is proprietary. The article notes that Wing, Redmond, and Verbeck have patented the pre-concentrator technology.
The devices are manufactured at a Pfeiffer Vacuum Inc. facility in Indiana. The InspectIR founders told Forbes they expect to produce 100 units per week in a start-up phase with plans to ramp up as sales increase. They also plan to look at applications for other respiratory diseases.
InspectIR has not announced exact pricing, but Time reports that the company will lease the equipment to clients, and that pricing per test will be comparable to rapid antigen tests.
InspectIR’s first breathalyzer device is receiving much positive coverage from the media. Should it prove to effective at spotting COVID-19 at popup testing sites, it may supplant traditional clinical laboratory rapid antigen tests as the screening test of choice.
Columbia University’s MediSCAPE enables surgeons to examine tissue structures in vivo and a large-scale clinical trial is planned for later this year
Scientists at Columbia University in New York City have developed a high-speed 3D microscope for diagnosis of cancers and other diseases that they say could eventually replace traditional biopsy and histology “with real-time imaging within the living body.”
The technology is designed to enable in situ tissue analysis. Known as MediSCAPE, the microscope is “capable of capturing images of tissue structures that could guide surgeons to navigate tumors and their boundaries without needing to remove tissues and wait for pathology results,” according to a Columbia University news story.
“The way that biopsy samples are processed hasn’t changed in 100 years, they are cut out, fixed, embedded, sliced, stained with dyes, positioned on a glass slide, and viewed by a pathologist using a simple microscope. This is why it can take days to hear news back about your diagnosis after a biopsy,” said Hillman in the Columbia news story.
“Our 3D microscope overcomes many of the limitations of prior approaches to enable visualization of cellular structures in tissues in the living body. It could give a doctor real-time feedback about what type of tissue they are looking at without the long wait,” she added in I News.
Hillman’s team previously used the technology—originally dubbed SCAPE for “Swept Confocally Aligned Planar Excitation” microscopy—to capture 3D images of neurological activity in living samples of worms, fish, and flies. In their recent study, the researchers tested the technology with human kidney tissue, a human volunteer’s tongue, and a mouse with pancreatic cancer.
“This was something I didn’t expect—that I could actually look at structures in 3D from different angles,” said nephropathologist and study co-author Shana M. Coley, MD, PhD (above), Director, Transplant Translational Research and Multiplex Imaging Center at Arkana Laboratories, in the Columbia news story. At the time of the Columbia study, Coley was an assistant professor at Columbia University and a renal pathologist at the Columbia University Medical Center. “We found many examples where we would not have been able to identify a structure from a 2D section on a histology slide, but in 3D we could clearly see its shape. In renal pathology in particular, where we routinely work with very limited amounts of tissue, the more information we can derive from the sample, the better for delivering more effective patient care,” she added. (Photo copyright: Arkana Laboratories.)
How MediSCAPE Works
Unlike traditional 3D microscopes that use a laser to scan tiny spots of a tissue sample and then assemble those points into a 3D image, the MediSCAPE 3D microscope “illuminates the tissue with a sheet of light—a plane formed by a laser beam that is focused in a special way,” I News reported.
The MediSCAPE microscope thus captures 2D slices which are rapidly stacked into 3D images at a rate of more than 10 volumes per second, according to I News.
“One of the first tissues we looked at was fresh mouse kidney, and we were stunned to see gorgeous structures that looked a lot like what you get with standard histology,” said optical systems engineer and the study’s lead author, Kripa Patel, PhD, in the Columbia news story. “Most importantly, we didn’t add any dyes to the mouse—everything we saw was natural fluorescence in the tissue that is usually too weak to see.
“Our microscope is so efficient that we could see these weak signals well,” she continued, “even though we were also imaging whole 3D volumes at speeds fast enough to rove around in real time, scanning different areas of the tissue as if we were holding a flashlight.”
A big advantage of the technology, Hillman noted, is the ability to scan living tissue in the body.
“Understanding whether tissues are staying healthy and getting good blood supply during surgical procedures is really important,” she said in the Columbia news story. “We also realized that if we don’t have to remove (and kill) tissues to look at them, we can find many more uses for MediSCAPE, even to answer simple questions such as ‘what tissue is this?’ or to navigate around precious nerves. Both of these applications are really important for robotic and laparoscopic surgeries, where surgeons are more limited in their ability to identify and interact with tissues directly.”
Clinical Trials and FDA Clearance
Early versions of the SCAPE microscopes were too large for practical use by surgeons, so Columbia post-doctoral research scientist Wenxuan Liang, PhD, co-author of the study, helped the team develop a smaller version that would fit into an operating room.
Later this year, the researchers plan to launch a large-scale clinical trial, I News reported. The Columbia scientists hope to get clearance from the US Food and Drug Administration (FDA) to develop a commercialized version of the microscope.
“They will initially seek permission to use it for tumor screening and guidance during operations—a lower and easier class of approval—but ultimately, they hope to be allowed to use it for diagnosis,” Liang wrote.
Charles Evans, PhD, research information manager at Cancer Research UK, told I News, “Using surgical biopsies to confirm a cancer diagnosis can be time-consuming and distressing for patients. And ensuring all the cancerous tissue is removed during surgery can be very challenging unaided.”
He added, “more work will be needed to apply this technique in a device that’s practical for clinicians and to demonstrate whether it can bring benefits for people with cancer, but we look forward to seeing the next steps.”
Will the Light Microscope be Replaced?
In recent years, research teams at various institutions have been developing technologies designed to enhance or even replace the traditional light microscope used daily by anatomic pathologists across the globe.
And digital scanning algorithms for creating whole-slide images (WSIs) that can be analyzed by pathologists on computer screens are gaining in popularity as well.
Such developments may spark a revolution in surgical pathology and could signal the beginning of the end of the light microscope era.
Surgical pathologists should expect to see a steady flow of technologically advanced systems for tissue analysis to be submitted to the FDA for pre-market review and clearance for use in clinical settings. The light microscope may not disappear overnight, but there are a growing number of companies actively developing different technologies they believe can diagnose either or both tissue and digital images of pathology slides with accuracy comparable to a pathologist.
Many of the mutations were found at sites on the spike protein where antibodies bind, which may explain why the Omicron variant is more infectious than previous variants
Scientists at the University of Missouri (UM) now have a better understanding of why the SARS-CoV-2 Omicron variant is more infectious than previous variants and that knowledge may lead to improved antivirals and clinical laboratory tests for COVID-19.
As the Omicron variant of the coronavirus spread across the globe, scientists noted it appeared to be more contagious than previous variants and seemed resistant to the existing vaccines. As time went by it also appeared to increase risk for reinfection.
The UM researchers wanted to know why. They began by examining the Omicron variant’s mutation distribution, its evolutionary relationship to previous COVID-19 variants, and the structural impact of its mutations on antibody binding. They then analyzed protein sequences of Omicron variant samples collected from around the world.
“We know that viruses evolve over time and acquire mutations, so when we first heard of the new Omicron variant, we wanted to identify the mutations specific to this variant,” said Kamlendra Singh, PhD, Associate Research Professor, Department of Veterinary Pathobiology at UM’s College of Veterinary Medicine (CVM), in a UM press release.
Kamlendra Singh, PhD (above), an associate research professor in the Department of Veterinary Pathobiology at UM’s College of Veterinary Medicine, led the team that identified 46 mutations of the SARS-CoV-2 Omicron variant. “I went to India last April and I got infected by the Delta variant. So, it then became personal to me,” he told NBC affiliate KOMU. The UM team hopes their findings lead to improvements in existing COVID-19 antivirals and clinical laboratory tests. (Photo copyright: University of Missouri.)
In their paper, the UM team wrote, “Here we present the analyses of mutation distribution, the evolutionary relationship of Omicron with previous variants, and probable structural impact of mutations on antibody binding. … The structural analyses showed that several mutations are localized to the region of the S protein [coronavirus spike protein] that is the major target of antibodies, suggesting that the mutations in the Omicron variant may affect the binding affinities of antibodies to the S protein.”
There are a total of 46 highly prevalent mutations throughout the Omicron variant.
Twenty-three of the 46 mutations belong to the S protein (more than any previous variant).
Twenty-three of 46 is a markedly higher number of S protein mutations than reported for any SARS-CoV-2 variant.
A significant number of Omicron mutations are at the antibody binding surface of the S protein.
“Mutation is change in the genome that results in a different type of protein,” Singh told NBC affiliate KOMU. “Once you have different kinds of protein after the virus and the virus attacks the cell, our antibodies do not recognize that, because it has already been mutated.”
Omicron Mutations Interfere with Antibody Binding
Of the 46 Omicron variant mutations discovered by the UM researchers, some were found in areas of the coronavirus’ spike protein where antibodies normally bind to prevent infection or reinfection.
“The purpose of antibodies is to recognize the virus and stop the binding, which prevents infection,” Singh explained. “However, we found many of the mutations in the Omicron variant are located right where the antibodies are supposed to bind, so we are showing how the virus continues to evolve in a way that it can potentially escape or evade the existing antibodies, and therefore continue to infect so many people.”
These findings explain how the Omicron variant bypasses pre-existing antibodies in a person’s blood to cause initial infection as well as reinfection.
The UM team hopes their research will help other scientists better understand how the SARS-CoV-2 coronavirus has evolved and lead to future clinical laboratory antiviral treatments.
“The first step toward solving a problem is getting a better understanding of the specific problem in the first place,” Singh said. “It feels good to be contributing to research that is helping out with the pandemic situation, which has obviously been affecting people all over the world.”
Singh and his team have developed a supplement called CoroQuil-Zn designed to reduce a patient’s viral load after being infected with the SARS-CoV-2 coronavirus. The drug is currently being used in parts of India and is awaiting approval from the US Food and Drug Administration (FDA).
New discoveries about SARS-CoV-2 and its variants continue to further understanding of the coronavirus. Research such as that performed at the University of Missouri may lead to new clinical laboratory tests, more effective treatments, and improved vaccines that could save thousands of lives worldwide.
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.
