Molecular diagnostics industry1/4/2024 ![]() 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. 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. 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. 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. “Within a matter of months, we adapted approaches developed over 40 years in labeling non-biological and biological matrices and clinical lab workflows. 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. 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. ![]() 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. Covid demonstrated that both innovation and adoption of new protocols are more achievable than previously assumed.Ĭovid 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. 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. ![]() 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. ![]()
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