The 2020 Wild, Wild West of Diagnostics
Autor
Tsongalis, Gregory J.
Kaul, Karen
Institución
Resumen
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.