Advanced diagnostics allow physicians to prescribe more targeted therapies with reduced toxicity and side effects, thus improving health outcomes while decreasing total system costs.
Hospital leadership must utilize real-time test utilization trends monitoring methods in order to maintain an effective laboratory stewardship program. Traditional data analyses offer only limited benefit in today’s healthcare ecosystem; immediate identification and tracking are therefore key.
France’s Advanced Diagnostic Ecosystem
Central laboratory services provide laboratory tests that assist physicians in detecting, diagnosing and managing illnesses. As part of healthcare ecosystem, they play an integral part in providing insights that aid medical decision-making as well as prevent disease to enhance quality of life and ensure patient survival globally.
Clinical labs play an essential role in monitoring bodily fluids such as blood, tissue samples, urine and stool samples for disease detection as well as providing vital health information about nutritional deficiencies and genetic disorders that impact humans.
In the United States, there are two main types of clinical laboratories that process medical specimens – hospital and private labs. Hospital labs serve the healthcare needs of their affiliated hospital while private labs receive samples from general practitioners, insurance companies, clinical research sites and health clinics; for extremely specialized tests they may send their samples out to other laboratories for processing.
Clinical labs are comprised of doctors and nurses as well as medical technologists – although the latter do not qualify as doctors themselves but instead perform essential diagnostic work. Technologists undergo training through accredited undergraduate degree programs leading to national board certification from the American Society for Clinical Pathology as Medical Laboratory Scientists (MLSs).
Medical technologists perform more than simply interpret laboratory results; in addition to that they also fulfill administrative responsibilities such as ordering test requests from physicians and returning completed tests to them or their hospital departments. Furthermore, they maintain patient records by maintaining databases with patient information as well as processing testing results.
Given the large volume of data produced by clinical laboratories, it is vitally important to put in place an effective system for managing information. Many have implemented electronic tracking of patient records and ordering tests – known as Laboratory Information System or LIS – while others have employed Lean quality and Six Sigma methodologies in order to speed turnaround time, reduce costs, and boost productivity.
With personalized medicine becoming more prevalent, more physicians are turning to advanced diagnostics as part of their efforts to confirm diagnoses and treat patients more precisely. This has resulted in demand for diagnostic tools that are more affordable, faster, and accurate than traditional methods – this demand being met by innovative start-ups in med tech like digital blood-testing apps or drug safety tech that are driving advances at clinical labs worldwide.
Advanced Diagnostics in the United States
Health care industry stakeholders are grappling with an ever-increasing diagnostic error crisis. According to a 2015 report by the National Academies of Sciences, Engineering, and Medicine, delayed, missed, or incorrect diagnoses cause more patient harm than all other forms of medical mistakes combined; one third of malpractice cases which lead to death or permanent disability involve diagnostic error as a cause. Congress has allocated funding for Research Centers of Excellence which focus on creating systems, measures and technologies which will enhance diagnostic safety within clinical practice environments.
Diagnostic companies face the primary challenge of proving that their test can assist HCPs in making more informed decisions and improve outcomes, which is known as actionability. Proving actionability takes considerable time and investment; often tests see negative returns for decades or more before seeing positive returns in revenue from successful initiatives that enhance HCP practice resulting in millions in sales for the company responsible.
Innovative companies are taking steps to speed up actionability by developing tests with greater accuracy and reliability, including those which can detect disease at an earlier stage or provide more precise test results such as biomarkers. Furthermore, these businesses are upgrading their software capabilities so as to automatically generate reports for clinicians as well as automate workflow tools to simplify ordering processes.
Reducing delivery delays of results to clinicians who require them is another area of focus, including streamlining transmission of laboratory results through electronic health records or patient-facing technologies, providing more in-depth interpretations, and making sure patients can easily understand them.
As a global medical technology company, BD is dedicated to supporting those at the frontlines of health care. That means offering innovative products, services and solutions that enable doctors to make more informed choices and improve outcomes for patients; scientists to accelerate medical discovery; and clinical therapy programs to advance. BD’s focus is to advance diagnostics so it becomes a standard of care and foundation of quality healthcare delivery.
Advanced Diagnostics in Europe
As healthcare moves towards predictive, preventive, personalized and participatory (4P), diagnostics have taken center stage. Diagnostic innovations provide earlier diagnosis, improve prognosis and treatment planning decisions and result in more efficient clinical interventions utilizing an unprecedented molecular understanding of patients and disease characteristics.
Broad adoption of these innovations can bring tremendous advantages to healthcare systems – including increased economic efficiency and better patient outcomes. Biopharma companies should establish relationships with diagnostics vendors who offer advanced tests related directly to therapeutic interventions.
However, European diagnostic test adoption faces many hurdles that must be surmounted before becoming widespread. Reimbursement remains the key challenge to wider adoption; manufacturers must convince regulators and medical opinion leaders of the test’s analytical performance and clinical utility in order to receive reimbursement; medical opinion leaders should promote its use; advocacy groups and politicians all need to support incorporating it into healthcare systems’ clinical pathways; manufacturers need to convince regulatory bodies of its analytical performance and clinical utility as part of reimbursement agreements; finally advocacy groups and politicians must support its incorporation.
Development, testing and marketing a new diagnostic is an expensive endeavor that often takes years of financial investment to accomplish successfully. R&D costs alone may often exceed 100% of revenue in certain instances resulting in negative profitability that discourages further investment into high-value tests.
Even when the value of a diagnostic is clear, its market penetration in Europe can take years – which restricts patient access. If a new infectious disease threat emerges suddenly, waiting months or years to design, approve and produce targeted diagnostics could prevent emergency responses being launched immediately.
Though these barriers exist, the EU is showing signs of progress. Germany’s market for advanced diagnostics is expanding thanks to strategic government initiatives. Meanwhile, France and other European nations are working toward creating value-based public sector pricing systems which would enable quicker decisions on reimbursement of high-value diagnostic tests; such an initiative may speed approval processes while increasing utilization in clinical practice.
Advanced Diagnostics in Asia
Diagnostic testing can support health systems to provide preventative and tailored care to each patient, but lack of access is an enormous obstacle in Asia – leading to particular challenges within this region.
One key issue facing Asia is limited availability of essential imaging devices and molecular tools imported from Western nations, leading to high costs and long wait times for patients. Some Asian nations are taking steps toward decreasing dependence on foreign imports by developing world-class devices locally – this approach may help lower patient costs while shortening waiting lists while meeting patient needs more effectively.
Another challenge facing ASEAN nations is their shortage of medical personnel to perform and interpret diagnostic tests, creating significant obstacles for healthcare economies that have yet to mature. A recent study determined that human resources for health in Cambodia, Lao PDR, Myanmar and Vietnam fell below WHO-recommended critical shortage threshold of 2.28 doctors, nurses and midwives per 1,000 population.
As such, training programs for medical personnel and laboratory capacity expansion must be developed and expanded accordingly. Partnerships between industry and academia with an eye on building up skillsets for future workforce are vital in this regard; alternatively investing in digital health solutions that connect medical practitioners and patients could also prove helpful in meeting this demand.
Reworking clinical protocols to emphasize early diagnosis is of particular concern in ASEAN, where viral hepatitis can progress into full-fledged cancer known as Hepatocellular Carcinoma (HCC), which can be treated if detected early enough; unfortunately however studies indicate that over half of HCC cases don’t show up this early stage.
Cultural issues related to fatalism towards illness and traditional concepts of femininity should also be taken into account in efforts to enhance cancer diagnosis in the region. If these themes exist, they could impede women from continuing with cancer treatments out of fear that doing so would rob them of their roles as wives and mothers.
In the ever-evolving realm of advanced diagnostics, Global Central Laboratory Service – Spinos stands as a cornerstone, driving precision in healthcare worldwide. As we navigate the complexities from Europe’s reimbursement challenges to Asia’s access barriers, the commitment to transformative diagnostics remains unwavering. Spinos leads the charge, ensuring a future where diagnostics empower personalized care on a global scale.