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Tuesday, July 7, 2020

Five dollars to save a life

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Ignorance is not bliss in a pandemic. That’s why widespread affordable testing is vital to containing COVID-19.

Experts such as Nobel laureate Paul Romer predict a need for several hundred million tests a week by later this year. The test that’s needed is an easy to use, highly accurate, rapid home combination antigen-antibody COVID-19 saliva test, with opt-in contact tracing and disease surveillance.

It can easily sell profitably for about $5, slightly more than the retail price of a high-end rapid home pregnancy test. But that’s a fraction of the $100 that companies, never wanting to waste a crisis, are now typically charging for COVID-19 tests.

To change that dynamic, a lesson needs to be learned from the AIDS epidemic. In the 1980s test manufacturers, medical groups, labs and others with a stake in the status quo fought to keep low cost rapid home tests off the market. I saw it up close after a company I founded submitted the first application for a home HIV test.

Despite clinical trial data showing safety and efficacy, after intense lobbying by opponents, FDA instituted a 25-year home HIV test ban, even as a third of people said it was the only way they’d test. As a result, hundreds of thousands got infected and died because they didn’t know they were having sex with an HIV infected person.

With COVID-19, politics and profits must be subordinated to the public good. To accomplish this the federal government needs to put out a bid for a reliable inexpensive test. Wanted: At least a billion rapid home COVID-19 tests at $5 per test.

If the federal government bows to politics, as it did with HIV, a coalition of states and private industry can put out the bid (many companies want to have rapid tests for their own use, including giving tests to employees to take home to test loved ones). A consortium will be needed to develop, manufacture and distribute this many tests. Manufacturing can be split among partners.

For distribution, a company like Walmart, which already runs many of the direct benefit programs for major insurers, and has systems in place to reimburse tests at the point of sale, would be an ideal partner.

Home tests can be used whenever and wherever people need to instantly know if they or someone they’re in contact with is infected. At $5, each billion home tests will cost about what 50 million of the current semi-reliable hurry-up-and-wait-for-results tests cost today. So high price won’t discourage testing.

A COVID-19 test needs world class design and technology to simplify its operation. Many of those who will be using it may be fearful, after all, and it will be used by people of all ages — including children and senior citizens. Contact tracing and disease surveillance is essential to help prevent new infections, so opt-in reporting must be integrated into the test, or a companion app. This information can be provided to CDC and state health departments.

Both an antigen and antibody assay are needed in one test. The antigen assay, which detects the SARS-CoV-2 virus, is particularly important because the virus begins to be detectable even before symptoms develop. This is especially significant since it is during this period of time that the virus is most infectious.

Since a rapid home test provides instantaneous results, asymptomatic people testing positive can take immediate steps to prevent spreading infection to others, and seek out medical guidance for themselves. An antigen test can also detect the virus in people who never develop symptoms, as well as in people with symptoms. As antibodies begin to appear the viral load decreases so the antigen test’s ability to detect infection declines. An assay to detect Covid-19 antibodies indicates someone has been previously infected and most likely has some degree of immunity.

Martin Luther King, Jr. said, “The time is always right to do what is right.” It is definitely timely to make reliable, inexpensive tests widely accessible, particularly to senior citizens and disadvantaged communities who are disproportionately affected by COVID-19 and may not have access to traditional tests. Spending $5 to save a life is always right.

Elliott Millenson is founder and CEO of Global Diagnostic Systems. He developed the first HIV home test.

Read More at Washingtonexaminer

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