The Future of Diagnostic Testing: Faster, Closer, and Driving Clinical Decisions

Diagnostic testing is no longer happening in the background – it has quickly become the frontline of clinical decision making in healthcare. In 2024, the FDA and CMS released a joint statement about the importance of accurate and reliable diagnostic tests, saying that “roughly 70% of healthcare decisions depend on laboratory test results.”¹

These tests work to help physicians make better, more informed decisions about building treatment plans for their patients. The diagnostic process is a complex, patient-centered, collaborative activity that involves information gathering and clinical reasoning with the goal of determining a patient’s health problem.²

In this blog, we take a look at how diagnostic testing has shifted to point-of-care, trusting the why speed is so important, and how artificial intelligence will play a role.

The ongoing trend toward point-of-care

With the pandemic, diagnostics shifted even more from the laboratory to the Point-of-Care (POC) and even home testing. In addition, CLIA-waived pharmacy sites surged 140% from 2019 to 2023³ and overall, the global POC diagnostics market is expanding rapidly at a 6-7% compound annual growth rate.⁴

By decentralizing diagnostic testing, results can be delivered to anyone from anywhere – as long as you have access to the test, you can get the test results.⁵ This shift towards POC testing eliminates any delays in transport and reduces the overall dependance on the workflow of the laboratory, allowing clinicians to make real-time, actionable decisions about a patient’s care.⁶

POC testing has had a profound impact on efficiency in the clinical environment, resulting in faster diagnosis of infections and disease, earlier initiation of care and therapies, better management of chronic diseases, and improved accessibility for underserved populations.⁷

Time is of the essence

Routine and preventive testing including glucose, lipid profiles, cancer screening and liver and kidney function tests are expected to make up 40% of the total volume in the global diagnostic market in 2026.⁸

Patients all over the world face diagnostic bottlenecks caused by shortages of specialists, overburdened hospitals, and lengthy diagnostic pathways which can have significant ramifications for their health and well-being, which is further supported by evidence⁹:

44% of HIV cases are reported as ‘late diagnosis’, with a 13% mortality rate.
Millions of cases of tuberculosis are left undiagnosed every year due to the massive backlogs in diagnosing that leads to transmission of the disease
Every four-week delay along the cancer care pathway increases the risk of death by 6%-13%⁹

Speed plays a big role in diagnostics, but trust and accuracy are incredibly important components of the diagnostic process. More than anything, patients need to be able to trust the accuracy of the results they are given.

COVID-19 showed the importance of POC testing with rapid antigen tests kits to diagnose in domestic settings, which had a decent accuracy rate and helped reduce the need to go to the hospital during the pandemic.¹⁰

Over the last few decades, POC testing has developed drastically, greatly benefiting from rapid technological advancements. Eventually, the goal for POC technology is to reduce the need for laboratory testing and lower the overload on medical healthcare services.¹⁰

Leveraging AI

As artificial intelligence continues to move into the healthcare space, it’s important that we find new ways to implement and leverage AI as a tool to improve workflows for clinicians and outcomes for patients.

AI will play a significant role in diagnostics by addressing bottlenecks like speed, accuracy, and consistency. Even the most skilled physicians are only human, making mistakes inevitable as they continue to experience burnout and fatigue. AI can analyze enormous amounts of data in seconds, catching things that the human eye might miss.¹¹

Integrating AI into healthcare is transforming diagnostic workflows, as machine-learning models deliver faster and more accurate image and diagnostic interpretation than traditional methods across oncology, cardiology, and radiology.¹¹ While it’s intended to support the workflow of clinicians, introducing technology like AI in its infancy can create other challenges, which makes cross-validation and rigorous checks critical for ensuring AI safety and reliability.¹²

How SEKISUI Diagnostics can help

No matter what the future of diagnostics looks like, the best solutions will be the ones that improve the well-being and health of the patient. The number one priority is that we are equipping providers with the tools that they need to deliver better patient care. Learn more about how we can help provide better diagnostic solutions across the healthcare industry.

References

The Future of Diagnostic Testing: Faster, Closer, and Driving Clinical Decisions

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