The 2020 Wild, Wild West of Diagnostics

Abstract

Regarding regulatory oversight of laboratorydeveloped tests (LDT) for molecular diagnostics, the Q7 Food and Drug Administration (FDA) often refers to the LDT space as the “Wild, Wild West,” making it seem like laboratories are all going rogue with respect to Clinical Laboratory Improvement Amendments Q8 (CLIA)-defined quality assurance practices. Now, with the challenges of the COVID-19 pandemic in 2020, the FDA finds themselves in a self-created Wild, Wild West regarding molecular and serologic testing for SARS-CoV-2. In December 2019, Chinese officials notified the World Health Organization of a cluster of severe pneumonia cases in Wuhan that had a suspicious origin. On January 7, 2020, the cause was identified, the novel severe acute respiratory coronavirus 2 (SARS-CoV-2), and the first death was reported in China several days later. By the end of January, cases were being reported globally, including the first case in Washington State, and travel bans were issued by some countries. The FDA released a guidance document for designing and validating molecular tests for SARSCoV-2 and issued the first Emergency Use Authorization (EUA) for a reverse transcriptase, real-time polymerase chain reaction (RT-PCR) assay to the Centers Q9 for Disease Control and Prevention (CDC) on February 4, 2020. The EUA specified that all diagnostic testing for SARS-CoV-2 be reviewed by the FDA, and in effect removed the option to offer testing as an LDT. This changed the landscape of molecular diagnostics for the virus and thrust the nation into a difficult situation because no assays other than the CDC RT-PCR test, available only to public health laboratories (PHLs), were accessible.