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No Lab Has a Closet Full of Tests For a Yet-to-be-discovered Infectious Agent
by: Dr. Monica de Baca
By now anyone with an internet connection knows that there is a new virus on the block and that we’re in the midst of a pandemic. As little as 4 months ago, no one knew of COVID-19. If the statement “No lab has a closet full of tests for a yet-to-be-discovered infectious agent” may have sounded obvious last October, these days it seems to be less obvious.
Let’s keep the timeline in perspective:
• December 31, 2019: China alerted the World Health Organization (WHO) to a cluster of patients with pneumonia of unknown cause. At that time, the virus itself was unknown.
• January 5th, 2020: China had ruled out a recurrence of SARS (severe acute respiratory syndrome virus) and by
• January 7, 2020: had identified a new virus named 2019-nCoV. As the CoV in the name suggests, this was identified as belonging to the coronavirus family of viruses. Initial diagnosis was based on genome sequencing.
• By Jan 21, 2020, several PCR assays had been developed (for example, at U. Hong Kong, China CDC).
• February 4, 2020: the US Secretary of Health and Human Services (HHS) determined that a public health emergency exists and that circumstances justify the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV). See HHS website for COVID-19 news.
• February 29, 2020: the FDA released a Policy for Diagnostic Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Diseases-2019 during the Public Health Emergency.
When new diagnostic laboratory tests are developed in the “routine” setting, the process is long complex, detailed, while being scrupulously regulated and scrutinized. Clinical laboratory testing is highly regulated to ensure that tests are rationally designed, are performed as designed, that results have a meaning that is understood, are shared between labs and among providers and to generally safeguard the population being tested.
In the pre-pandemic world, developing news tests required significant review of the literature, determination of the necessity for FDA approval/clearance, evaluation of CLIA complexity status, selection of test methods, specimen types, quality and validation studies (validation studies include ascertainment of accuracy, precision, analytical specificity and sensitivity, identification of a reportable range, reference range and detection limit, establishment of interferences or co-reactions, etc.). In the case of an infectious disease, labs must have positive samples to test— until there is an isolated infectious agent that is being tested, no assay can “test positive” for that agent. Similarly, if the number of positive cases is limited, it is essentially impossible for a laboratory to have access to the body fluids, blood or tissues from which the infectious agent could be isolated.
Diagnosing an infectious disease also requires understanding the way that illness is contracted and how the body reacts to the initial infections: what is the time period between contact and the development of symptoms? At what point in this timeframe does a diagnostic test become positive? Is the presence of the infectious agent by a sensitive test always equivalent to disease? Is the newly ill patient contagious at the same time as the symptoms develop? Or even before?
With the newly released policy, the FDA is permitting a relative loosening of some of the usual methodology and regulatory restrictions routinely employed in new test design once an emergency has been recognized; it cuts through red-tape and green-lights the speedier development of novel testing.
Orchestrating the development of a new test for a new pathogen from within a newly emerging epidemic is about as hard as it gets. Yes, there are supply chain issues. Yes, there are issues of public health deployments. Yes, there are issues with national coordination. No, we haven’t figured out isolation and adequate detection. And how to get the economy back on track. And we are heartbroken about the people lost to the disease. And. And. And…… And hundreds of thousands of tests have been run for Covid-19 in the last months. For just one minute, let’s recognize the scientific and medical community for the amazing accomplishment this represents. This is not a lunar landing, this is a significantly greater achievement. Take a picture: that’s us, sitting on a new star, just 4 months after it was discovered.
When there’s a vaccine - someone may even throw us a party.
Gestalt’s Advisory Board guides the development of Gestalt’s digital pathology platform,
PathFlow® – made by pathologists for pathologists
A Digital Pathology Today podcast with Lisa-Jean Clifford of Gestalt - A Fresh Start for Pathology
Gestalt Diagnostics, Inc., a leading provider of (AI)-driven digital pathology solutions, is proud to announce the launch of its leading-edge AI Algorithm Evaluator. This groundbreaking, patent-pending tool empowers pathologists, researchers, and healthcare professionals to assess and compare the performance of AI algorithms with unprecedented precision directly within our award-winning PathFlow® solution. This new feature will be demonstrated during the USCAP 2024 conference in Baltimore this week.
March 20, 2024 – Spokane, Washington – Gestalt, a leading provider of (AI)-driven digital pathology solutions, is excited to announce a series of significant enhancements to its educational module and digital pathology solution, within the PathFlow® solution. These advancements underscore Gestalt's commitment to transforming healthcare from every perspective. Our newly expanded Education Module now includes automated, digital evaluation, proficiency testing, credentialing management, and results comparison features. Designed to streamline and ease the heavily manual processes of pathologist proficiency testing, onboarding, and credentialing. "Our commitment to innovation extends across all facets of pathology, from Anatomic Pathology (AP), Research, and Education to Management and Administrative functions. These enhancements reflect our vision for a future where education and technology converge to improve operational processes," says Lisa-Jean Clifford, Chief Strategy Officer and COO at Gestalt Diagnostics. "Our solutions are designed to significantly streamline workflow, enhance efficiency, support patient safety, and offer improved quality and cost. We believe that delivering products with these goals in mind will have a major impact on operations within healthcare, academic, and research facilities, for the pathologist, scientist, and clinician, ultimately providing faster, more accurate diagnosis and treatment for the patient and optimized operations with significant savings to organizations." Gestalt Diagnostics has a proven track record of excellence. Its customers are already leveraging the company's expertise for primary diagnoses*, tumor boards, onboarding and training, collaboration, and supporting remote access for hundreds of client pathologists who are geographically dispersed. Additionally, Gestalt supports research and retrospective image and data capture for over 10 million pathology slides. Join us at USCAP, March 23-28, at booth #554 to see how our efforts in clinical, education, and research initiatives are setting new standards in digital solutions. *Research use only unless following CAP guidelines for LDT. CE-IVD certified for use in Europe.
Featured in G2 Intelligence January 2024—In an insightful discussion on the evolving landscape of data analytics within clinical laboratories, Lisa-Jean Clifford, COO and Chief Strategy Officer at Gestalt Diagnostics, highlights the integration of data analytics across various facets of laboratory operations. She emphasizes its critical role in enhancing operational efficiency, resource management, and patient safety. Clifford's commentary sheds light on the extensive applications of data analytics in lab environments—from streamlining operational workflows to improving patient care. She also addresses the challenges labs face, such as navigating the vast array of data analytics solutions and the need for specialized knowledge in pathology informatics. Moreover, Clifford points to the promising future of digital solutions and AI in expanding the capabilities of clinical labs, suggesting a burgeoning potential for growth and innovation in the field.
January 11, 2024 – Spokane, Washington – Gestalt announces the addition of Sagis Diagnostics to their customer roster. Recognizing the evolving landscape of healthcare technology, Sagis has embraced a transformative approach to their pathology services and has added digital pathology to their strategy. Gestalt’s industry leading, award-winning platform will be implemented for use in clinical and academic workflows, to include integrated artificial intelligence algorithms. By leveraging cutting-edge technology, Sagis aims to streamline the diagnostic process and enhance overall efficiency. The advantages of transitioning to digital pathology for the company include reducing operational costs and delays related to courier services and enabling real-time collaboration and access to patient cases for pathologists in various locations. “We believe that digital pathology is not just a technological upgrade but a strategic move towards a more sustainable and efficient future. By partnering with Gestalt, we aim to provide our pathologists with a state-of-the-art platform that aligns with our commitment to excellence," said Lynn Brock, COO at Sagis. “The thorough evaluation of various vendors led us to select Gestalt as the preferred partner. Through an exhaustive comparison of features, applications, and a detailed matrix analysis, Gestalt emerged as the vendor that best met our requirements, ticking off all the crucial aspects in clinical, research, and educational domains. This decision aligns with our commitment to staying at the forefront of technological advancements in healthcare.” The decision to embrace digital pathology was driven by several key factors. Initially, Sagis recognized significant cost-saving potential by eliminating the need for daily courier services to multiple cities in Texas, while also addressing challenges posed by weather conditions and unforeseen disruptions. Furthermore, Sagis sought to leverage Artificial Intelligence (AI) capabilities to empower pathologists and optimize diagnostic processes. The integration of AI allows for the pre-screening of specimens before pathologists begin their workday, ensuring a prioritized and efficient diagnostic workflow. A crucial aspect of this shift is the ability to attract and retain pathologists in an ever-shrinking pool of talent. The flexibility offered by digital pathology allows pathologists to work remotely, eliminating the need for relocation. This not only addresses the current challenges in hiring pathologists but also positions Sagis as an innovative and attractive employer in the healthcare sector. Gestalt COO & Chief Strategy Officer, Lisa-Jean Clifford says, “This shift represents a significant milestone in Sagis's commitment to delivering high-quality pathology services while embracing the opportunities presented by digital innovation. We are proud to work with innovative laboratories like Sagis who have a broad vision for expansion and use of technology and the positive impact this transition will have on patient care, as well as the broader healthcare ecosystem.” About Sagis Sagis is an entirely physician-led pathology group backed by a CLIA and CAP-accredited histology lab located in the heart of Houston, Texas. With board-certified and subspecialty-trained pathologists always within reach, we deliver the highest quality services to physicians, physician groups, ambulatory surgery centers, and hospitals. Our commitment to quality and excellence is built upon our expertise and the utilization of the latest diagnostic tools. Providing accurate, prompt, and clear diagnoses in a personal and customizable manner, we prioritize our referring physicians' needs. As a patient-centric facility, we strive to deliver the best medical care possible. Visit Sagis at www.sagisdx.com *Research use only unless following CAP guidelines for LDT. CE-IVD certified for use in Europe.
This award is another validation of Gestalt's contributions to supporting better healthcare through technology.
Featured in CAP TODAY December 2023—Digital pathology and AI—the push, the potential, the changing questions, the reimbursement, and the caution. All that and more came up when CAP TODAY publisher Bob McGonnagle led a conversation online with pathologists and industry representatives, featuring Lisa-Jean Clifford, COO and Chief Strategy Officer of Gestalt.
With the advancement and expanded uses of technology in the laboratory we have a host of opportunities in the hands of physicians and scientists to explore and study diseases in-depth and in a way that we historically have not been able to. Read on to discover more...
