Illumina receiving emergency use authorization (EUA) from the Food and Drug Administration (FDA) for diagnosing COVID-19 using its next generation sequencing (NGS) technology could not have come at a more critical period during this pandemic. This breakthrough will most likely provide much needed relief in the global backlog of COVID-19 diagnostic tests, according to GlobalData, a leading data and analytics compay.
Illumina is set to have a strong foothold in the COVID-19 diagnostic market in the current fiscal year. The COVIDSeq™ Test is now a front-runner among many other test types thanks to its high-throughput, sequencing-based and rapid reporting capabilities. Given its sheer scalability, speed and accurate reporting of diagnostic data over many of its competitors, GlobalData predicts its widespread use in the upcoming months. Unfortunately there are a couple of caveats with this development. While the COVIDSeq™ Test has the potential to be widely used, it has yet to be officially cleared of FDA approval, as it currently falls under an EUA. As such, this test is only authorized for clinical use during the defined state of emergency, after which it will have to undergo the standard regulatory requirements. Furthermore, unlike at-home diagnostic tests, which have become increasingly popular due to many patients’ growing reluctance of visiting healthcare providers, this test does require patients to seek their healthcare providers for collecting samples via various swabs. Nevertheless, the COVIDSeq™ Test addresses the ever-increasing demand for large-scale COVID-19 testing across the globe, as a more robust method of conducting diagnostic tests has been sought after in recent weeks.”
Brian Hicks, Medical Analyst at GlobalData