Opinion: Containing Covid-19 requires rapid tests that are highly sensitive to infections. Why is the FDA asking for something different?

With rapid testing becoming a key tool in the fight against Covid-19, in a mid-October call with the White House I offered to sell my Covid testing company — recently valued at $99.8 million — to the government for just $1. As an alternative, I also offered to sell the government our test at cost.

My company, Global Diagnostic Systems, had just completed clinical trials showing our rapid Covid-19 home test had 100% sensitivity (meaning no false negatives) and 95% specificity (meaning just 5% false positives). On hearing about this performance, a senior White House official told me, “Apply to the FDA ASAP.”

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