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Featured in Medical Laboratory Observer - MLO, September 2025 Written by Lisa-Jean Clifford, President, Gestalt Fast, accurate diagnosis of men’s most pressing health issues can dramatically improve outcomes, reduce treatment complexity, and enhance overall quality of life. By identifying conditions early—from heart disease to cancers—clinicians can initiate timely interventions that save lives, preserve function, and lower long-term healthcare costs. Of these conditions, all but diabetes and unintentional injury are most often being diagnosed, and treatment plans being determined, based upon information coming from the laboratory. Although, diabetes can lead to health problems that would also land in the direct purview of the laboratory as well. So, let’s dive into each of these a bit. Lung cancer Men are more likely to be diagnosed with lung cancer and less likely to survive it compared to women. The rate of new cases in 2019 was 23% higher in men than women (59 versus 48 per 100,000, respectively), and the five-year survival rate was 39% higher among women than men (30% versus 21%, respectively).1 Skin cancer Skin cancer is the most common of all human cancers. About 1 in 5 Americans will get some type of skin cancer in their lifetime, and more than two people die of skin cancer every hour in the United States. Skin cancer affects people of all skin colors. There are three major types of skin cancers: basal cell carcinoma, squamous cell carcinoma (SCC), and melanoma. The first two skin cancers are grouped together as nonmelanoma skin cancers.2 Colorectal cancer By 2030, cases of colorectal cancer in people under 50 are expected to double.3 The death rate from colorectal cancer for people ages 20 to 54 rose between 2004 and 2014. Before then the death rate had been going down (American Cancer Society). Most people under 50 with colorectal cancer do not have a family history of the disease (American Cancer Society). Black people of all ages, including young adults, are more likely to get and to die from it than any other group. Colon and rectal cancers are both cancers of the intestine. However, their treatments are quite different. Colon cancer Colon cancer is the third most common type of cancer in the United States. However, it is also one of the most curable, and survival rates have been increasing over the past several years. Awareness and early detection are key—colon cancer can often be caught in its early stages, when treatment can be most effective. There are several different ways to test for colon cancer. After reviewing clinical history and doing a basic medical exam, a physician will most likely perform a colonoscopy. Treatment often involves surgery, chemotherapy, and/or radiation. Rectal cancer The rectum sits in a tight space in the body, narrowly separated from other organs and structures in the pelvic cavity. As a result, complete surgical removal of rectal cancer is challenging and complex There are several different ways to test rectal cancer. The most common path for diagnosis will include an ultrasound to see how far through the rectal wall a cancer has grown and a colonoscopy. Rectal cancer often requires more than one type of treatment and much like colon cancer usually involves surgery and a combination of chemotherapy and/or radiation treatments. However, given the complex nature of the rectum, it also often involves partial or total reconstructive surgery or will result in a colostomy bag. Testicular cancer The American Cancer Society’s estimates for testicular cancer in the United States for 2025 are: About 9,720 new cases of testicular cancer diagnosed About 600 deaths from testicular cancer The incidence rate of testicular cancer has been increasing in the United States and many other countries for several decades. The increase is mostly in seminomas. Testicular cancer is not common: about 1 of every 250 males will develop testicular cancer at some point during their lifetime. The average age of males when first diagnosed with testicular cancer is about 33. This is largely a disease of young to middle-aged men, but approximately 6% of cases occur in children and teens and approximately 8% occur in men over 55. Because testicular cancer usually can be treated successfully, the mortality rate for this type of cancer is very low: about 1 in 5,000. Artificial intelligence and machine learning: AI algorithms now analyze ECGs, imaging scans, and clinical data to flag subtle abnormalities faster than traditional methods. Predictive models can forecast disease progression and personalize follow-up intervals. Prostate cancer Prostate cancer ranks among the top cancers in men, especially those over 50. It often grows slowly, allowing many men to remain asymptomatic for years. Early and precise diagnosis of prostate cancer relies on identifying molecular signals—biomarkers—that distinguish healthy tissue from malignancy. Biomarkers guide decisions about who needs a biopsy, what treatments to pursue, and how to monitor treatment response and disease progression. Advances in molecular testing and imaging now allow clinicians to tailor care based on each man’s unique cancer profile. The role of biomarkers in prostate cancer: A biomarker is any measurable molecule in the body that reflects normal or disease processes. In prostate cancer, biomarkers can indicate tumor presence, aggressiveness, and likelihood of recurrence. Incorporating these markers into routine evaluation helps avoid unnecessary biopsies, reduces overtreatment, and pinpoints the most effective therapies for each patient. Mesothelioma Men are significantly more affected by mesothelioma, a rare type of cancer that develops in a layer of tissue that covers most internal organs. Men are over four times more likely to contract mesothelioma, because 80 percent of people with this cancer report at least one exposure to asbestos. Men over 65 who have worked in trade occupations or the military are at the highest risk for this kind of cancer. Idiopathic pulmonary fibrosis Idiopathic pulmonary fibrosis (IPF) is another type of cancer found predominantly in men — 70% of all cases. It is a disease that causes scarring of the lungs. Idiopathic means it has no known cause. IPF symptoms usually appear later in life, with most people being diagnosed over age 50. Symptoms most often include shortness of breath, a dry cough, weight loss, and fast, shallow breathing. IPF does not have a cure and is progressive but can be slowed with medication and treatment, which may also alleviate symptoms for the patient. Viruses In the laboratory, viral infections can be confirmed by multiple methods. Diagnostic virology has changed a great deal due to the increase in molecular techniques and increased clinical sensitivity of serological assays. A large variety of samples can be used for virological testing. The type of sample sent to the laboratory often depends on the type of viral infection being diagnosed and the test required. Cardiovascular disease (CVD) The diagnosis of CVD often begins with identifying clinical symptoms that may indicate underlying heart problems. While some individuals may experience obvious warning signs such as chest pain, shortness of breath, or palpitations, others may have no or atypical symptoms that impede early detection. Fatigue, dizziness, swelling in the legs, and unexplained weakness can also be indicative of cardiovascular issues. In some cases, symptoms appear only during physical exertion, while in others, they occur unpredictably at rest. Beyond traditional diagnostic tests, advanced imaging techniques have revolutionized the early detection of cardiovascular disease. Coronary artery calcium scoring performed using computed tomography (CT) helps assess the presence and extent of calcified plaques in the coronary arteries. This test is useful for identifying those who are not yet displaying symptoms of heart disease. Magnetic resonance imaging (MRI) offers high-resolution images of the heart’s structure and function, making it a valuable tool for diagnosing congenital heart disease, myocarditis, and fibrosis. Similarly, cardiac computed tomography angiography (CCTA) provides detailed images of coronary arteries, allowing clinicians to detect narrowing or blockages with high precision. Laboratory tests and biomarkers for CVD diagnosis: Blood tests play a key role in diagnosing and monitoring the progression of cardiovascular disease. High levels of cholesterol, triglycerides, and inflammatory markers such as C-reactive protein indicate an increased risk of atherosclerosis. Similarly, tests measuring levels of troponin are essential for diagnosing acute myocardial infarction. Other biomarkers, such as B-type natriuretic peptide (BNP), help assess heart failure severity, while glucose and hemoglobin A1c levels provide insights into diabetes-related cardiovascular risks. Latest advancements in the diagnosis of CVD: The diagnosis of CVD has evolved significantly with the integration of leading-edge technologies such as artificial intelligence, machine learning, and advanced imaging techniques. AI-powered algorithms now assist in analyzing ECGs and imaging scans, allowing for faster and more accurate diagnosis. Wearable devices with real-time monitoring identify irregular heart rhythms and provide early indication of heart disease. Genetic testing enables physicians to assess hereditary risks and predict cardiovascular conditions before symptoms are present. All of these advancements improve how CVD is diagnosed, leading to more personalized and proactive healthcare. Genetic testing helps in the diagnosis of CVD: Genetic testing plays a key role in identifying individuals at risk of developing cardiovascular disease. By analyzing specific gene mutations associated with inherited heart conditions, such as hypertrophic cardiomyopathy and familial hypercholesterolemia, physicians can detect heart disease before symptoms appear. Genetic profiling can also help determine an individual’s response to medications, allowing for more personalized treatment plans. Artificial intelligence improves the accuracy of diagnosis: Artificial intelligence is transforming how cardiovascular disease is diagnosed by enhancing the interpretation of medical imaging, ECGs, and patient data. AI-driven algorithms analyze large volumes of clinical data to identify patterns that can be missed by humans, leading to earlier and more accurate diagnoses. Machine learning models can also predict the likelihood of heart disease progression, enabling proactive treatment plans. AI applications in radiology help improve the detection of arterial blockages through automated image analysis. As AI continues to evolve, it will play an increasingly vital role in refining how to diagnose heart disease with greater speed and accuracy. Conclusion The power of early, accurate diagnosis results in the following: Improved survival rates : Detecting disease at a treatable stage increases survival and remission rates for cancers and chronic illnesses. Reduced treatment intensity : Early intervention often requires less aggressive therapy, sparing men from extensive surgeries or high-dose, often toxic medications. Enhanced quality of life : Preventing complications maintains physical function, mental health, and independence. Cost savings : Early diagnosis reduces hospital stays, emergency care, and long-term management expenses. The integration of biomarkers into prostate cancer care is transforming diagnostic pathways from one-size-fits-all to highly personalized algorithms. Ongoing research aims to combine biomarker profiles with advanced imaging and artificial intelligence to detect cancer even earlier and more accurately. As these tools mature, men will benefit from fewer invasive procedures, smarter treatment choices, and better long-term outcomes. Early recognition of symptoms, a thorough understanding of risk factors, and the integration of traditional and innovative diagnostic tools are reshaping men’s health in both diagnosis and care. By leveraging advanced imaging, biomarker profiling, AI analytics, genetic insights, and wearable monitoring, physicians can detect disease earlier, initiate precise treatments, and significantly improve men’s health trajectories. Proactive screening and personalized diagnostics pave the way to longer, healthier lives. REFERENCES American Lung Association. Four diseases threatening men’s lung health. Lung.org. Accessed September 3, 2025. https://www.lung.org/blog/lung-diseases-threatening-men. Ellis RR. An overview of skin cancer. WebMD. December 31, 2006. Accessed September 3, 2025. https://www.webmd.com/melanoma-skin-cancer/skin-cancer. Bailey CE, Hu CY, You YN, et al. Increasing disparities in the age-related incidences of colon and rectal cancers in the United States, 1975-2010. JAMA Surg. 2015;150(1):17-22. doi:10.1001/jamasurg.2014.1756.

Featured in Medical Laboratory Observer - MLO Written By Lisa-Jean Clifford, President, Gestalt Planning is Essential As digital pathology and artificial intelligence (AI) continue to transform diagnostic medicine, laboratories find themselves at a timely and critical juncture. These technologies are not simply enhancements, they represent a fundamental shift in how clinical images and data are managed, routed, shared, viewed, interpreted and presented to pathologists. Laboratories that wish to remain at the forefront of innovation must evolve beyond traditional automation and digitally replicating their manual workflows. Instead, the lab who successfully implements these solutions must carefully evaluate its technical infrastructure to accommodate complex, image-centric workflows, multi-source data integration, and AI-assisted analysis. This evolution requires careful analysis and review of platforms that not only handle high-resolution whole slide images (WSIs), but also enable interoperable communication across diverse systems—such as scanners, LIS’s, EMR’s, EHR’s, and archives—using both native file formats and standardized protocols like DICOM. Successful implementation of digital pathology and AI depends upon a robust informatics ecosystem that supports interoperability and real-time data exchange between your applications. These include information that will be displayed in your viewer such as WSI’s, structured annotations, snapshots, AI overlays and results outputs but also includes patient specific case information like you traditionally see in your LIS. These tools must be securely embedded within workflows, ensuring compliance with privacy regulations, while remaining scalable for multi-site deployments. And, this transformation is not solely technical. It requires training and cultivating a digitally fluent workforce, with training initiatives that enable pathologists, lab (and scanning) technicians to navigate the components of the process seamlessly and accurately. Assess current infrastructure preparedness Before implementing new technologies, it’s essential for laboratories to assess their existing systems and infrastructure. This includes evaluating scanner compatibility, data storage capabilities, and network bandwidth to ensure readiness for high-volume imaging, robust case routing and AI integration. Understanding what's already compatible and supports this initiative can help identify gaps, avoid redundant investments, and lay the foundation for seamless upgrades. A thoughtful audit sets the stage for informed decisions and smoother transitions into digital pathology and automation. Key considerations include: Scanner selection – Do you already have scanners in place? If so, are the digital solutions you are evaluating compatible with all of them? Do the scanners fit the needs of your organization in terms of volumes, speed and quality of scanning, redundancy? Are they dated or current in terms of the technology? If they aren’t, or you don’t have scanners these are all items to consider in your evaluation and acquisition of scanners. Keep in mind that the better digital platforms will support multiple scanner brands and models, enabling you to mix and match the scanners that best suit your organizations needs. Information Management System(s) – Is your LIS/EMR/EHR interoperability ready or compatible? Is it an older, legacy system that will have limitations or challenges with being able to send and receive real-time data messages through standard methods of integration? Can your digital solution providers help bridge any of these gaps or do they have ways they can work around them in order to provide a seamless workflow for your pathologists and your technologists? If your information system or “source of truth” for the patient is current and easy to integrate with other solutions, do you have one or multiple you are looking to integrate with? Are you a multi-site entity or single location with one LIS or one version of that LIS? All of these are points to consider when determining: 1. Which digital solution you select; and 2. If there are other infrastructure changes you need to make to ensure that your applications are able to speak to each other effectively. Network Bandwidth – Most robust digital solutions today are web-based, as is the storage for these large images. It is essential to understand what your current network supports and to plan to make modifications prior to implementing a digital platform. Speed and performance are a huge factor in the successful usage and adoption of your platform. Most digital solutions are going to be optimized for performance, but internet and network bandwidth are two things that no vendor can account for. There are certainly things like load balancing and viewer performance that are important parts of the development and tuning process of vendors, however, providing the proper bandwidth and connectivity is something that the lab – or your IT department – will need to plan on. Storage options – Preplanning is an important step here as well. Knowing whether you are going to archive all of your images or some of your images and for what amount of time is a key consideration. Also understanding your options and selecting the one (or two) that are right for you is important. Are you planning to store locally/onsite? In the web? Does your digital solution provider offer both short – and long-term storage? Are you looking to use one of the large storage vendors (Google, AWS, Azure)? Understanding the price difference between these options, and if your digital solution provider can integrate bi-directionally with them is also a fundamental consideration. On this note – any decision you make in this category can be easily changed. Configure for Interoperability A successful digital pathology deployment depends upon integration, real-time data exchange and true interoperability. Support for image formats – Enables streamlined viewing, image sharing and best of breed selection for your organization across platforms. Are you looking to integrate your other ‘ologies’ and have a cross patient perspective by being able to collocate radiology and pathology images? If so, you also need to ensure that your systems support DICOM and integration with VNRs. Open APIs and HL7 – Enable seamless connectivity with LIS, AI algorithms, other lab applications and modules, and advanced analytics platforms Vendor-Neutral solutions – Avoid vendor lock-in by selecting digital platforms that offer interoperable viewers, databases, workflows and reporting. Choose AI vendors and algorithms that align with your needs AI algorithms should be carefully considered and evaluated to ensure that you address your specific clinical needs rather than adopt them as generic tools. Successful integration requires a thoughtful alignment by your digital pathology solution and the AI vendor. Those who have formed partnerships have put a great deal of thought and technical evaluation into the integration between the capabilities of their AI outputs and the digital workflow and visual representation to the pathologist. Whether it's assisting with tumor detection, streamlining case triage, or supporting specific diagnosis and cancer grading, AI solutions should be targeted to enhance clinical workflows and improve decision-making. By integrating AI deployment directly within your digital platform’s viewer, you are enabling your workflow to be grounded in the realities of patient care and operational demands, ensuring that laboratories can have a meaningful impact, increased efficiency, and better outcomes. Modernizing your lab’s infrastructure isn’t a single upgrade—it’s a strategic transformation. By focusing on compatibility, clinical utility, and scalable systems, labs can future-proof their operations and unlock the full potential of digital pathology and AI.