COVID-19 Testing Delays Caused by Red Tape, Cut in SK

COVID-19 Testing Delays Caused by Red Tape, Cut in SK

Low volumes of bureaucratic paperwork required to bring COVID-19 tests to the market may have been South Korea’s secret weapon in successfully combating the coronavirus at the critical early stages.

The Food and Drug Administration said in a new report issued Tuesday that South Korea was prepared to deal with a pandemic because of already existing close partnerships between the Korea Disease Control and Prevention Agency, KDCA, and the private sector.

“When COVID-19 hit, South Korea prioritized the early detection of SARS-CoV-2 through diagnostic testing. The KDCA developed its own test and made it available in late January 2020,” when Korea reported its first known case of the novel coronavirus, the report said.

South Korea also subsidized the development of COVID-19 testing kits, “informing private test developers that the government would absorb the financial risk of developing SARS-CoV-2 diagnostic tests by guaranteeing to purchase minimum quantities of tests, once authorized for use.”

The FDA report said the United States by contrast did not incentivize test development “early on” although “de-risking and incentivizing product development” later became foundational policy for vaccines.

The centralized testing capability was also critical to testing success in South Korea.

According to the FDA, the KDCA had the testing capability in existing labs for clinical studies. The country had coped with other deadly outbreaks, including Middle East Respiratory Syndrome in 2015.

“As a result, test developers did not have to find their own clinical specimens or viral material to validate their tests, which likely shortened the length of time needed to complete validation studies to support Emergency Use Authorization applications and increased the government’s confidence in test accuracy.”

The United States, in comparison, became buried under more than 2,000 EUA requests, which were being submitted from independent laboratories, the FDA said.

South Korea’s coronavirus cases have surged in recent weeks. The country reported 707 new cases Wednesday, bringing the cumulative caseload to 137,682, according to government data.