Point-of-care testing: a look ahead

Aug. 2, 2015

Point-of-care technology (POCT) isn’t a new concept, yet the degree of acceptance and, therefore, the rate of adoption vary considerably around the world. In some regions the flexibility that a true POC device delivers has facilitated a significant change in the way in which healthcare is administered for millions of patients; in some cases, these patients may previously have had no access at all to healthcare.

In other countries, where POC testing has been available for perhaps a decade or more, developers are constantly looking for new functionality and applications that will allow POC to maintain its presence within the spectrum of diagnostic technology.
A frequent topic of debate is the role that POCT plays in clinical labs. Are the benefits to patients and healthcare systems as tangible as POC developers would suggest they are? Is POCT a threat, or is it complementary, to lab analysis?
In truth, the most successful application of POCT is achieved through true collaboration with clinical labs. Patient-power can also play a role, as many of the benefits of POC testing are the intangible aspects, such as speed to result. There are a number of developments that will help bring these objectives to reality:

Connectivity. The ability to feed data derived from POCT into laboratory information systems (LIS) has long been a topic of debate. There are several standards available, but perhaps more importantly, POCT developers recognize that the ability to share patient data is no longer a nice-to-have but a necessity. A joined-up approach to patient management is just around the corner, where it doesn’t already exist.

Quality control. Standards within POCT have long been a minefield, although the establishment of industry standards through organizations such as the AACC and IFCC in the 1990s gradually brought order where previously there was little. In recent years the POCT industry, especially within the diabetes area, has seen standards tighten further. This has placed demands on developers to embark on a process of continual improvement to ensure that they can deliver data that stands up to scrutiny and removes barriers from the path to integration as a valuable part of a lab’s portfolio. This landscape is set to become clearer with the update to the current ISO 13485 standard this year and the replacement of the current IVD directive with the new IVD regulations for Europe.

Miniaturization. One of the primary product benefits of POCT is the portable nature of the analyzers and the tests. Small, hand-held devices mean that the patient no longer has to visit the medical setting. This has benefits in rural communities but also in busy, developed economies where some patient groups can be hard to reach during their daily routines. The logical next step of miniaturization is wearable technology; watches released by Apple and Pebble this year are the latest in a line of technology to come loaded with functionality that hints at a mobile future for healthcare and diagnostics.

Patient-focused solutions. This covers a multitude of areas but is essentially focused on putting patients and their needs at the heart of the development process. Whether it be the advent of non-invasive testing, the ability to deliver an accurate result instantly, or the ability to test for multiple parameters from one tiny sample, the patient is the primary beneficiary. Expect to see more developments that make the use of POCT more and more patient-centric in a way that more traditional forms of diagnostic testing cannot hope to achieve. As the National Institutes of Health (NIH) has pointed out, these developments are key to the “[shift] toward prevention and early detection of disease, as well as management of multiple chronic conditions.” (http://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=112)

Personalized medicine. Within oncology, the ability to treat individuals based on the genomic make-up of their tumor’s DNA allows treatment programs to be tailored on an individual level. Although POCT in its truest sense has not reached molecular technology as yet, the development of devices that collect circulating tumor cells using blood, rather than tissue sample, suggests the possibility of POC tests for many types of cancer. The early detection of tiny fragments of mutated material as part of a screening program using low-cost technology that is minimally invasive is attractive to both patient and the organization picking up the bill.

POCT is, arguably, the most significant growth area within diagnostics. The potential for the technology, because of the low cost of implementation and the future paradigm of mobile and wearable diagnostic devices, is vast and allows a vision of personalized, affordable healthcare.