Everyone should have access to reliable, quality diagnostics. According to the CDC, 70% of healthcare decisions are made based on lab results, demonstrating the significant need for access to accurate diagnostic testing.¹ Point-of-care (POC) testing has long promised to improve the current diagnostic paradigm of waiting days to get results from a central lab. With POC testing, rapid information enables doctors to provide patients with high-quality results in a quick timeframe that allows for the faster diagnosis of new issues and the regular monitoring of previously diagnosed conditions. Furthermore, for patients who may have difficulty accessing medical care for a variety of reasons, the ability to diagnose and treat conditions in a single visit offers significant value in improving outcomes.²

     Despite the early promise of POC testing, there have been significant barriers to the widespread implementation and adoption of POC testing outside of the most basic types of testing, like urine dipstick and pregnancy tests. High operating costs, both from an operator, instrumentation, maintenance, and test reagent price standpoint; limited insurance coverage and related billing nuances; and finite test menus are just some of the many challenges that have prevented many healthcare providers from moving their routine testing towards the point-of-care.³ “Largely, across the board, we pay way too much for a point-of-care test that can be done in a laboratory environment, and that just pushes [insurance companies] to force patients to go to a reference lab,” said Dr. Nathan Ledeboer, PhD in a recent interview with Fluxergy CEO and Co-Founder Tej Patel.⁴

     The advantages of POC are numerous. There is rarely a clinical scenario where waiting for results would result in better treatment for the patient. In the age of consumerism, patients are less willing to wait for critical results that traditionally take up to a week. While healthcare centers shifted towards centralized laboratories in the past, POC testing allows for more testing in resource-limited and mobility-restricted populations, bettering health equity for these patients.⁵ Some of the most compelling benefits of POC testing include faster results for faster clinical decisions, increasing access to testing in lower resource and/or rural areas, and simplifying the workload for healthcare staff. However, the barriers to implementing rapid testing remain too high for most practices to fully adopt this technology.

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High Costs

     When considering the breadth of devices required to fulfill common test orders, many healthcare centers opt to continue sending samples to central labs to avoid the associated operational costs of POC: cost per device, cost per test, additional equipment for testing, training costs, and labor costs for staff to perform the tests. Many insurance reimbursements fail to cover the test cost alone, leaving the healthcare practice in a deficit for choosing POC. There is significant opportunity for the next generation of POC diagnostic solutions to overcome the cost barrier with more cost-effective instrumentation and test reagents, including the consolidation of multiple testing technologies into a single instrument that limits costs.

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Inferior Assay Performance to Gold Standards

     POC testing can only be successful at scale if their performance is equivalent to lab-based gold standards.⁶ This has not always been the case, as the performance of the early generations of POC tests have not achieved this performance standard, greatly limiting their adoption by healthcare providers.  The next generation of POC solutions must achieve lab-quality performance in a format that is easily performed in CLIA-waived settings and is not cost-prohibitive for the value the testing provides.

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Limited Test Menu

     One of the established pitfalls of POC devices is their limited assay menus.⁷ Most platforms are designed to process a single testing modality (i.e. cytometry, molecular, immunochemistry, etc.) or a single test (i.e. blood glucose levels). It becomes cost prohibitive to a majority of healthcare providers in decentralized, resource-limited settings to acquire and maintain up to five different POC instruments in order to perform routine blood and infectious disease testing.  However, having a multitude of devices can cause difficulties in testing workflows and in maintaining patient logs. Broader test menus will be driven by diagnostic manufacturers with the engineering expertise to consolidate multiple testing technologies into a single platform with standardized workflows.

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Fitting in the growing value-based care paradigm

     POC testing is exceptionally well-suited for the growing value-based care paradigm due to its ability to provide rapid and accurate diagnostic results directly at the site of patient care. This immediacy allows healthcare providers to make timely clinical decisions, which can significantly improve patient outcomes and reduce overall healthcare costs.⁸ By minimizing the need for extensive laboratory infrastructure and enabling quicker follow-up actions, POC testing supports the goals of value-based care, which emphasizes quality over quantity of services. Additionally, POC testing enhances patient engagement and satisfaction by involving patients more directly in their care and providing them with immediate insights into their health status.⁹ This alignment with value-based care principles makes POC testing a crucial component in modern healthcare delivery systems and is critical for the next generation of POC platforms.

     Fluxergy presents a unique angle in solving the POC problem. Founded in 2013, we’re an Irvine, CA-based medical diagnostics manufacturer with a platform to change the utility of rapid diagnostics and increase access to high quality testing. Fluxergy's multimodal platform can combine molecular, immunochemistry, clinical chemistry, and hematology modalities to run the most common test orders. Through innovative manufacturing practices, we’re designing our assays to be priced at or below insurance reimbursement rates. The company’s in-development launch bundle includes a respiratory panel (COVID/Flu A/Flu B/RSV), a basic metabolic panel, and a complete blood count (CBC) panel with 5-part differential, targeting release within the next few years .* Fluxergy will detail in subsequent pieces how we are addressing the issues pertaining to POC test adoption mentioned in this article with our Fluxergy Platform.

_{* Fluxergy’s launch bundle includes a respiratory panel (COVID/Flu A/Flu B/RSV), a basic metabolic panel, and a complete blood count (CBC) panel with a 5-part differential. This bundle is currently in development with an expected premarket approval from FDA in 2027.}

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References

1: FDA and CMS Statement: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made | CMS. (2024, September 9). https://www.cms.gov/newsroom/press-releases/fda-and-cms-statement-americans-deserve-accurate-and-reliable-diagnostic-tests-wherever-they-are#:~:text=Physicians%20heavily%20rely%20on%20laboratory,Control%20and%20Prevention%20(CDC).

2: Larkins, M. C., & Thombare, A. (2023b, May 29). Point-of-Care testing. StatPearls - NCBI Bookshelf. https://www.ncbi.nlm.nih.gov/books/NBK592387/#:~:text=POCT%20provides%20rapid%20turnaround%20of,outcomes%20compared%20to%20laboratory%20testing.

3,6: Hardy, V., Thompson, M., Alto, W., Keppel, G. A., Hornecker, J., Linares, A., Robitaille, B., & Baldwin, L. (2016). Exploring the barriers and facilitators to use of point of care tests in family medicine clinics in the United States. BMC Family Practice, 17(1). https://doi.org/10.1186/s12875-016-0549-1

4: The Future of Point-of-Care Testing: Interview with Dr. Nathan Ledeboer (PhD). (n.d.). https://www.fluxergy.com/blog/the-future-of-point-of-care-testing-interview-with-dr-nathan-ledeboer-phd

5: The expanding role of point of care testing. (2019, August 5). https://myadlm.org/cln/cln-daily/2019/the-expanding-role-of-point-of-care-testing

7: Dincer, C., Bruch, R., Kling, A., Dittrich, P. S., & Urban, G. A. (2017). Multiplexed Point-of-Care Testing – XPOCT. Trends in Biotechnology, 35(8), 728–742. https://doi.org/10.1016/j.tibtech.2017.03.013

8: Chaunie Brusie & Chaunie Brusie. (2019, March 19). point of care diagnostics - Clinical Lab Products. Clinical Lab Products. https://clpmag.com/diagnostic-technologies/point-of-care/mastering-diagnostics-at-the-point-of-care/

9: Plebani, M., Nichols, J. H., Luppa, P. B., Greene, D., Sciacovelli, L., Shaw, J., Khan, A. I., Carraro, P., Freckmann, G., Dimech, W., Zaninotto, M., Spannagl, M., Huggett, J., Kost, G. J., Trenti, T., Padoan, A., Thomas, A., Banfi, G., & Lippi, G. (2024). Point-of-care testing: state-of-the art and perspectives. Clinical Chemistry and Laboratory Medicine (CCLM). https://doi.org/10.1515/cclm-2024-0675