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Emerging Trends in Point-of-Care Testing

By Saif Ali Bepari
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Technologically superior devices, favorable research outcomes and a supportive regulatory structure are fueling growth.

This article enumerates some of the most compelling applications of the point-of-care (POC) testing market that will serve to expand the frontiers of this industry in the forthcoming decades, aided by a slew of highly innovative technological advancements. Characterized by a stringent regulatory spectrum that aims to curb the disease burden worldwide, the POC testing industry is also expected to garner momentum from numerous research programs that address the issue of testing appropriate treatment methodologies for numerous disorders.

Having evolved into its own business vertical, the POC testing market has emerged as an indispensable part of modern healthcare, as it is improving the quality, availability, accuracy and affordability of high-end patient care worldwide. The design of POC testing devices is progressing at a rapid pace, with more powerful devices incorporating advanced technology that has entered the market. The rising proliferation of these sophisticated devices is setting the stage for the unprecedented growth of the global POC testing industry.

Manufacturers of POC devices continually seek ways to design products that offer improved user comfort in a cost-effective manner. POC devices launched in recent years have continued to support targeted innovations across various disease types based on the growing understanding in the healthcare community of the underlying causes of ailments like cancer and other chronic conditions. The technological advancements are further assisting healthcare professionals in reducing the lengthy turnaround times for tests and are positively impacting the planning of research studies, especially when there is a need to optimize numerous different protocols.

Technological Enhancement and Extensive Research: Factors Changing the Face of POC Testing Applications

Blood Glucose Testing

POC technology has revolutionized diabetes care, opening up a host of effective options for frequent and timely measurements of blood glucose, not only in clinics and hospitals but also in the patient’s home. To fully comprehend the significance and contribution of POC testing technology in managing diabetes care, it would be prudent to mention that the number of people with diabetes worldwide has risen from 108 million in 1980 to 422 million in 2014, according to the World Health Organization.

Taking into account the growing demand for advanced POC testing devices and the need to popularize accurate diabetes management practices, major market players are launching improved blood glucose monitoring devices in an effort to make the testing experience hassle-free and convenient. For instance, healthcare giant Roche introduced a new blood glucose monitoring system Accu-Chek Guide, which helps in on-board pattern detection via a mobile application . Given that the system is a cloud-based solution, healthcare providers, caregiver, and diabetics can share the glucose readings from virtually anywhere for remote monitoring and timely advice.

In addition, renowned tech and e-commerce companies are entering the POC testing market to lower the financial burden and provide affordable diabetes supplies at the patient’s doorstep. For instance, last year Amazon launched a new healthcare brand Choice, which offers blood glucose meters, lancets, and strips and reduces the hassle of visiting a pharmacy. The launch of digitally-connected blood glucose testing systems and the easy access to these sophisticated devices is set to boost the growth prospects of POC testing industry in the coming years.

Cancer Biomarker Testing

According to estimates released by the International Agency for Research on Cancer, the global cancer burden rose to 18.1 million new cases in 2018 . To put things in perspective, the organization has noted that the total number of people who are alive within five years of a cancer diagnosis, called the five-year prevalence, stands at 43.8 million iv. In this context, the detection of cancer biomarkers is said to be crucial in determining the course of treatment pertaining to patients diagnosed with cancer. Remarkably, cancer biomarkers have emerged as one of the cornerstones of anticancer treatment plans and are assisting physicians in assessing prognosis of the disease.

Researchers are also focusing on simplifying cancer biomarker tests to bring about a distinctive change in the way the healthcare providers diagnose cancer. Outcomes of a few research studies have been highly encouraging and are set to revolutionize the POC testing industry. For example, researchers at the University of Queensland have recently discovered a unique cancer biomarker and have developed an test to detect it in blood and biopsy tissue. The new technology was tested on 200 human cancer samples and the accuracy of cancer detection recorded was as high as 90%, which is quite significant in comparison to other cancer biomarker tests currently available in the POC testing market.

HIV Testing

Expanding HIV-related POC testing in resource-limited countries could play a major role in realizing the objectives set by the Joint United Nations Programme on HIV and AIDS under its 90-90-90 target. It is important to note that HIV-related POC testing methods increase the coverage of testing and expand the scope of this technology beyond urban centers to reach the rural populace.

In 2015, the World Health Organization (WHO) published a handbook called “Improving the Quality of HIV-related Point-Of-Care Testing” in which it noted that the scale-up and implementation of HIV-related POC testing has been on the rise, with 23% of CD4 testing being performed using these technologies in 2013. More than 118 million people received HIV tests in 124 low-and middle-income countries.

With ambitious disease prevention targets and the growing number of POC tests, development of advanced HIV diagnostic solutions, which provide quick and accurate results, is a critical need. Keeping this aspect in mind, some well-known POC testing market participants are launching new devices and methodologies that deliver results faster. For instance, Abbott unveiled a new POC test in the Netherlands named m-PIMA HIV-1/2 VL , which enables screening and treatment in a single visit, as it delivers results in 70 minutes.

As viral load testing is considered to be the benchmark for monitoring ART treatment failure, the new test is said to be the first of its kind for viral load measurement at POC. The development of such exemplary tests by POC testing industry players can be considered crucial, as WHO recommends every person receiving ART must undergo a viral load test at six-month and 12-month intervals.

In addition to rapid technological advancement and research activities, the regulatory institutions governing the medical diagnosis and overall healthcare domain across various nations are increasingly promoting the use of cost-effective and readily accessible POC testing devices, especially in areas where central laboratory services are impractical.

Enumerated below are a couple of notable instances that highlight the efforts being undertaken by regional regulatory authorities to promote POC testing technology:

  • Regarded as one of the most efficient health services in the world, NHS England launched a three-month consultation and guidance calling for general practitioners to prescribe cheaper alternatives of blood glucose test strips for people with type 2 diabetes .
  • In order to improve the performance and safety of POC testing devices, in 2018 the FDA reissued two draft guidance documents to assist manufacturers in conducting performance studies on blood glucose monitoring test systems used for POC testing purposes.

Understanding the local gap in terms of testing coverage and the need for POC testing devices in the context of disease prevalence and access to services is crucial in achieving universal healthcare targets. Considering the cumulative impact of cloud-based POC testing solutions and strengthening of the existing quality assurance and quality improvement practices, the usage of POC testing devices is set to increase at higher-tier health and laboratory settings across developed and emerging economies in the coming years.

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About The Author

Saif Ali Bepari