LAUSR

The past year marked what for many is the most significant event they have yet lived through. The global scale of the COVID-19 pandemic was mind bending; the gravitas further cemented by its continued duration. Every person’s experience is unique, but several common threads exist, including the spotlight it would shine on the pharmaceutical industry. This is a somewhat reductive statement as there are so many facets to consider within the space, but I think it is appropriate as it was portrayed that way in most media. I was given an opportunity to be a part of this, working at BioAgilytix as a Business Development Assistant selling COVID-19 testing services. I would see not only this side, but as a student at William Jewell College where I participated in ‘Operation Safe Campus.’ This testing/safety regimen included testing by MRI Global very similar to BioAgilytix’s own testing program. I am uniquely positioned to reflect on how the pandemic spotlighted the pharmaceutical industry, and what that looked like. 31 December 2019 marked the beginning of the progression of the SARS-CoV-2 virus with the first official case in Wuhan, China. However, it was not until 9 January that the World Health Organization (WHO) began to suspect there could be a novel coronavirus causing the mysterious respiratory symptoms. The WHO began development of a detection assay for the virus; however, in many countries, where the capabilities to develop their own tests existed, the WHO-developed tests were not adopted [1]. The reasoning behind this decision remains unanswered in many countries, such as the USA. Later experience demonstrated that testing is one of the most effective methods for mitigating the spread of SARS-CoV-2, yet, in October 2021, over 700,000 lives have been tragically lost in the USA alone [2]. The USA has lagged in COVID-19 mitigation efforts, with similarly developed nations reporting 40% fewer associated deaths per capita. How this massive failure occurred is, and will remain, a pertinent point as epidemiologists and crisis aversion experts fight to prevent future pandemics. Certainly, an earlier commitment to and roll-out of more effective testing procedures would have minimized the impact. While the pandemic period has given rise to some of the fastest scientific discoveries and developments, such as development of the new mRNA vaccines, it was also characterized by overly politicized and slow, ‘too little too late’ administrative decisions. One example of this within the USA was the seemingly slow decision to allow Clinical Laboratory Improvement Amendments (CLIA)-approved labs (which perform testing in human specimens) to design their own testing kits [3]. There seemed to be a lack of coherent messaging on the responsibilities of both public and private institutions regarding testing, quarantine and other pandemic response measures. The necessity of the development of independently developed CLIA-certified lab kits became even more critical when the US CDC realized their own assay was producing unreliable test results [4]. There was eventually the reduction in regulatory requirements through aggressive application of the US FDA’s Emergency Use Authorization process for tests; however, testing remained bottlenecked for most people throughout 2020. In lieu of a national lockdown, the CDC created a set of guidelines to ensure that people could continue their lives with some semblance of normalcy. The guidelines developed were often unclear and had a number of conflicting