Balancing Quality and Speed in the Market Approval of Diagnostic Tests

Abstract

Mass testing has proven to be a critical pillar in the fight against a pandemic. 1 The COVID-19 crisis has demonstrated, especially in the early months of the pandemic, how a lack of reliable data regarding the number and distribution of infections led to an underestimation of the health risks and late and erratic containment policies. 2 Countries that deployed early mass testing, such as the Republic of Korea (South Korea) did, have been the most successful in dealing with the pandemic. Mass testing

The COVID-19 Pandemic – A Diagnostic Industry Perspective

“…Additionally, it is vital to establish clinical endpoints and desired performance parameters early to provide adequate transparency to the diagnostic assay developers. Regulatory agencies and policymakers should ensure that the diagnostic community can always access the required data infrastructure to evaluate different testing strategies ( Wiegmann and Roca, 2021 ). Regulatory coordination is also of paramount importance on a global scale, and both national and international organizations should collaborate to develop comprehensive response plans and determine adequate regulatory approval processes.…”

Error in Subtitle

“…In the Viewpoint titled “Balancing Quality and Speed in the Market Approval of Diagnostic Tests,” 1 published online on July 9, 2021, the subtitle incorrectly listed the countries from which the experiences were drawn. This article was corrected online.…”