Better availability and a new type of “open-source diagnostics” are coming as a response to increased demand for molecular testing during COVID. This is good news for consumers, similar to other open-source technologies that have spurred innovation, expanded markets, increased scalability and created applications faster. Large manufactures like Abbott and Labcorp have worked to make home testing available, and smaller companies like Enzo Biochem have restructured to make testing technologies, products, reagents and assays based on an novel open-source platform.
Back in the old days before COVID, diagnostic testing services followed a routine process. Doctors ordered tests. Patients provided samples that were processed by a diagnostics company. Results were sent to doctors who plan an appropriate course of treatment. Patients rarely had direct access to a diagnostic test and almost never without authorization from a healthcare provider, often requiring an in-office visit. And while OTC options in diagnostic testing for select needs such as pregnancy confirmation and testosterone testing have become available, these choices were limited.
Consumer familiarity with the diagnostics sector and testing technologies has historically been rather low. All that has been changing rapidly and dramatically since the onset of COVID. Within weeks of the pandemic shut downs, demand for diagnostic testing rose exponentially and consumers were required to learn how to directly access testing services. The established model for access to molecular testing became quickly outdated, and consumers had to adapt to new testing procedures and previously unfamiliar concepts including the difference between “PCR,” “rapid antigen” and “antibody” testing. The rapid scale up also highlighted the fact that testing services were often not available in convenient locations in many areas in the U.S.
The diagnostics industry, meanwhile, had to work to develop a range of new testing products and capabilities with unprecedented scale based on the prevalent “closed testing” model commonly used by industry leaders. Mostly testing technologies could only be operated with the manufacturer’s own proprietary reagents, assays and other products. Third party testing facilities could only get the right chemicals from the manufacturers, who claimed this allows for better quality control. However, the COVID pandemic put a spotlight on scalability. If testing centers are dependent on a single supplier, they can only scale up services as rapidly as production expands from one source. When testing services needed to scale up exponentially early in the pandemic, many manufacturers could not meet demand, making it impossible to achieve target goals in testing capacity.
The industry also faced a challenge based on the capabilities of available testing technologies and the demand for rapid and accurate testing results. The reality has been that you can have testing that is fast or accurate, but not both. COVID demonstrated that a stronger focus on improving testing speed is achievable in an environment where rapid accurate testing becomes essential.
There have been deficiencies in the diagnostics sector’s response to COVID, yet the challenges are driving new levels of innovation that will have a pronounced effect on the future of diagnostic testing in the U.S. and around the world. Both larger and smaller players in the diagnostics space are adapting their business models in ways that will significantly strengthen our ability to respond to future global health crises. COVID demonstrated that both innovation and adoption of new protocols are more achievable than previously assumed.
Bringing testing closer to the consumer
COVID quickly made it apparent that access to testing had to expand beyond traditional settings including hospitals and diagnostic testing centers. The industry responded by taking steps to make testing available in more convenient locations. In February 2021, the Labcorp™ COVID-19 PCR Test Home Collection Kits became available over-the-counter at hundreds of Walgreens stores in the U.S. This shows how expanded networks for service delivery are becoming an important competitive advantage for diagnostics companies in an environment where customers demand fast and convenient access to testing services.
Transitioning to open platform systems
In planning to expand capacity to meet demand for its testing products and services, Enzo Biochem quickly realized that a closed system platform would not support the levels of scale up that were already on the horizon early in the pandemic. A closed-platform system for molecular testing offers advantages including a guaranteed market for a manufacturer’s products and services, but the limited ability to scale up production to meet demand can have devastating consequences. Enzo took steps to restructure its operations to be able to develop COVID testing technologies and products including reagents and assays based on an open platform, making it possible for their own testing centers as well as third party testing sites to use their technology while being able to access the products they need from multiple suppliers.
“Within a matter of months, we adapted approaches developed over 40 years in labeling non-biological and biological matrices and clinical lab workflows. This shows that the industry can and must adapt to more open platforms in the years ahead,” said Kara Cannon, chief commercial officer, Enzo Biochem.
The need for speed
With a highly infectious agent such as COVID-19, the ability to test people quickly is a central element in an effective response. While a trade-off between speed and accuracy must be carefully considered, the industry applied advanced learnings about achievable efficiencies in molecular testing that can serve as a template for future development programs, even those outside of a crisis situation. In one early example, in March 2020 Abbott received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for what was then the fastest available molecular point-of-care test for the detection of novel coronavirus, delivering positive results in as little as five minutes and negative results in 13 minutes. The technology also could be used in non-hospital settings including physicians’ offices or urgent care clinics.
The post-COVID diagnostics world
While many of the examples of innovation in the diagnostics sector over the past 18-months were directly driven by the COVID response, there is no indication that they are either temporary or not readily adaptable to other opportunities in molecular testing. Consumers are now more familiar with diagnostic testing than ever before and are accustomed to access the tests they need at convenient locations on demand. In addition, while the benefits of rapid results will differ based on the testing need, there is now a broader awareness in the sector that technology and new protocols can deliver test results faster, potentially leading to earlier diagnosis and intervention and more rapid assessments of trends in incidence. Perhaps more than any health issue in the last 50 years, COVID-19 has helped to show both what was lacking and what is now possible in diagnostic testing.