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.”
At a cost of about $2 a test, the government could make 166 million tests for the same $232 million it paid in May to buy 8.5 million tests from an Australian company that had already received $30 million in U.S. government funds from the National Institute of Health’s Rapid Acceleration of Diagnostics (RADx) initiative to develop its rapid Covid antigen test, which retails for $40.
But after my call with the White House, the Food and Drug Administration instituted ill-considered guidelines that make our test — and other similarly solid tests — “unacceptable” for authorization. The new FDA guidelines now say that rapid Covid home tests should have at least 98% specificity (2% false positives), but can have as low as 80% sensitivity (20% false negatives). That’s consistent with tests currently on the market, most of which have high specificity but sensitivity in the mid-80% to low-90% range.
That’s the wrong way to go.
A key to containing the impact of Covid-19 is early detection and early treatment. That calls for highly sensitive tests, so positive cases aren’t missed. Everyone who takes a rapid Covid-19 test before getting together with others — whether in an office, at home, or on a football field — wants to be as confident as possible that a negative result is a true negative. Those who are at high risk of severe consequences if they become infected, such as the elderly and those who are immune compromised, are particularly concerned with the accuracy of negative test results. They should be able to choose a test that is extremely sensitive, which reduces the chance of a false negative.
Yet the FDA is doing the opposite — encouraging tests with low sensitivity — which will often falsely tell people infected with SARS-CoV-2, the virus that causes Covid-19, they are negative. It’s unwise.
For example, a test made by OraSure, which received $327 million in government funding to develop it, has 98% specificity and 84% sensitivity. Abbott’s BinaxNOW, the most popular rapid test, has 98.5% specificity and 84.6% sensitivity, though a CDC study found just 64.2% sensitivity.
It should be easy to see the value of distributing billions of highly sensitive Covid tests to a nation of nearly 330 million people who need to routinely test themselves for Covid-19. A negative result can give reassurance. Those who test positive can isolate themselves to prevent spreading infection and, if needed, get early treatment.
An airborne virus knows no boundaries. Today’s Covid-19 outbreak in South Africa leads to next month’s infection in the south of France and South Carolina. To quell the pandemic, the government should initiate and lead a consortium funded by multiple nations to distribute Covid-19 tests, treatments, and vaccines around the world. Such a program not only makes sense for humanitarian reasons — like PEPFAR for HIV/AIDS — it’s also in the U.S.’s enlightened self-interest.
The pandemic has already seen successful partnerships between small companies and large ones, like BioNTech and Pfizer in vaccines and Ridgeback and Merck in treatments. Given the pressing need for Covid-19 tests, an entity created out of a partnership between a testing company — mine, or any one of several others — and the government makes sense. The government can invoke the Defense Production Act to speed production of low-cost tests, even using manufacturing facilities it has already funded for much more expensive tests, to quickly make and distribute tests. The realities of this virus, which mutates and evolves, demands that test performance be continually evaluated. For future outbreaks, an organization would be in place to efficiently and effectively develop, make, and distribute low-cost tests.
I formed Global Diagnostic Systems in 2020. We had one key goal: to develop a sensitive, easy-to-use, affordable home test for Covid-19. Development was guided by a key tenet of epidemic control: the need to detect infection early so people can isolate to prevent infecting others and get treatment if needed. So we designed the test to be highly sensitive to limit the number of false negatives.
After a year of hard work and achieving our goal, why would we give the company away? With billions of people on the planet needing tests, it’s essential that rapid Covid-19 tests be inexpensive, easy to use, and highly sensitive. But only the U.S. government has the resources and credibility to harness the production resources to make and distribute billions of tests each month to Americans and others around the world. To help save lives, we felt it was a privilege and honor to offer our company to the government.
As I write this, 1,300 Americans are dying every day from Covid-19. Rapid, highly sensitive tests can help save lives. The FDA needs to revise its guidelines for authorizing rapid tests and the Biden administration needs to employ smart strategy, powerful weapons, and decisive leadership to win this war. The offer to sell the government our company for $1 still stands.
Elliott J. Millenson is the CEO of Global Diagnostic Systems. He was the CEO of Direct Access Diagnostics, which developed the first FDA-approved home HIV test.
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