Thread by @PardisSabeti

A year into the COVID-19 pandemic, we still lack a testing and surveillance system to stop SARS-CoV-2 or respond to new variants that might emerge. How did we get here and where can we go? A thread based on our @NEJMperspective nejm.org/doi/full/10.10… 1/11

U.S. has 3 core issues: 1. limited bandwidth & support for labs to rapidly stand up new tests 2. over-reliance on commercial manufacturers leading to testing shortages & perverse incentives 3. failure to prioritize symptomatic over asymptomatic testing. Some startling facts: 2/11

Of 260,000 CLIA labs, only 45 built their own FDA-approved COVID Laboratory Developed Tests, and only ~200 are using LDTs pre-FDA approval. Even removing all regulations didn’t convince labs to build LDTs, & may have been a deterrent - as loss of oversight adds liability. 3/11

Meanwhile, commercial manufacturers were faced with perverse capitalistic incentives, leading to instances of price gouging. In extreme cases, prices of Covid tests have reached over $2,000. 4/11

As a result, we have dramatically underperformed. While needed turnaround times for tests are 1-2 days at most, results in the US take ~4 days. Racial & socioeconomic disparities persist in both test access & turnaround time, with African Americans waiting ~5 days. 5/11

Meanwhile, focused on their recovery, our prior administration, professional sports teams, businesses, colleges, and others began testing many thousands of asymptomatic people, sometimes daily, often while embedded in communities that still struggle to access reliable tests. 6/11

Asymptomatic surveillance testing is a useful addition to a robust testing strategy, but when testing and resources are scarce, it is wasteful and can even be ineffective in protecting the groups surveyed, as the White House outbreak demonstrated. 7/11

To stop COVID-19 & prevent the next pandemic, we must:
1. Create a path for clinical labs to build LDTs & get regulatory approval
2. Provide R&D resources to all test developers
3. Prioritize clinical test distribution by need & support new approaches to non-clinical testing 8/11

This is not our first global pandemic and it will not be our last. New emergent pathogens are constantly circulating around us, and we are all vulnerable. Let us create better capacity, systems, and practices today to build pandemic preparedness for tomorrow. 9/11

Thankful to co-author Dr. Eric Rosenberg & @ MGH team whose efforts to build a COVID-19 LDT w/ our @BroadInstitute team helped inspire this piece, to co-author Yolanda Botti-Lodovico @BottiYolanda, our terrific @sabeti_lab Policy Lead, and to @NEJM for sharing our piece. 10/11

And thanks to @NEJM Executive Managing Editor Stephen Morrisey @srm128 for talking with me about this further in the NEJM podcast nejm.org/action/showMed… 11/11