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RELEASE: Rep. Khanna Presses FDA to Approve Rapid, Affordable In-Home Paper-Strip COVID-19 Testing

September 10, 2020
Press Release

Washington, DC – Today, Rep. Ro Khanna (D-CA) led a bipartisan group of thirteen Members of Congress in sending a letter to the Food and Drug Administration (FDA) urging the agency to consider an expedited authorization and modified sensitivity standards for low-cost, rapid, in-home coronavirus tests. Recognizing that frequent, affordable testing is necessary to return to normalcy—absent an authorized COVID-19 vaccine or cure—the letter asks the FDA either to create a new pathway or to give special consideration for these high-frequency screenings outside of their current authorization standards. 

“While the current sensitivity-standard is appropriate for polymerase chain reaction (PCR) testing for those who are showing symptoms or have recently been in contact with a COVID-19-positive individual, reopening our economy will require a scalable solution,” the lawmakers wrote. “These faster tests can catch people when they have the highest levels of virus—that is, when they are most contagious—and often before symptoms begin to show. We need a broad public health strategy that allows for consistent monitoring of institutions and communities.”

Medical researchers have developed COVID-19 tests that can be produced for as little as one dollar per test and produce at-home results in as few as 15 minutes. These tests can be made of paper and operate similarly to a pregnancy test. A user might simply spit on the paper, drop it into a saline solution, and await results. No labs or nasopharyngeal swabs are necessary. 

At present, the FDA hasn’t authorized rapid paper-strip tests because they fail to meet the high sensitivity threshold set for the slower, more expensive PCR tests. However, despite their lower sensitivity, the paper-strip tests’ frequency will ultimately catch more COVID-positive patients than PCR tests. The tests affordability will allow Americans to use them every day or every other day in the same way that they might check their temperature. If a test returns positive, the individual would self-quarantine and call their doctor to schedule a PCR test. If a test is negative, the person would continue to wear a mask and social distance, but with added confidence that they aren’t infectious themselves.

Rep. Khanna is joined by Rep. Rodney Davis (IL-13), Rep. Andy Kim (NJ-03), Rep. Bill Foster (IL-11), and Rep. Kim Schrier (WA-08) in leading this letter to the FDA. 

You can read the full letter here or below.

 

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About the Office

Congressman Khanna represents the 17th District of California, which covers communities in Silicon Valley. Visit his website at khanna.house.gov. Follow him on Facebook, Instagram and Twitter @RepRoKhanna.

 

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Stephen Hahn, M.D.

Commissioner

United States Food and Drug Administration

White Oak Campus

10903 New Hampshire Avenue

Silver Spring, MD 20903

 

Dear Commissioner Hahn:

We are writing to request the United States Food and Drug Administration (FDA) consider an expedited authorization and lower sensitivity standards for low-cost, rapid, in-home coronavirus tests. In the absence of an authorized vaccine or cure for COVID-19, returning to a normal way of life will require affordable, frequent testing for almost all Americans.

The medical research community is working to develop technology[1] that would allow a user to test their own saliva on a paper strip indicating if the individual may be infectious with COVID-19 within as little as 15 minutes. At a price point as low as one dollar per strip, these screenings can easily be mass-produced and distributed usage daily or every other day. 

While the current sensitivity-standard is appropriate for polymerase chain reaction (PCR) testing for those who are showing symptoms or have recently been in contact with a COVID-19-positive individual, reopening our economy will require a scalable solution. A recent Duke University paper[2] co-authored by Mark McLellan, the former FDA Commissioner under President George W. Bush, argues for, “broad availability of more rapid but sometimes less accurate screening tests...to detect outbreaks sooner and give people more confidence in their workplaces and schools.” These faster tests can catch people when they have the highest levels of virus -- that is, when they are most contagious -- and often before symptoms begin to show. We need a broad public health strategy that allows for consistent monitoring of institutions and communities. 

We appreciate the FDA’s recently released application template[3] for at-home testing, which signals the importance of these types of screening tools, but we have heard from experts who believe the standard remains too strict. Based on the work of scientists from Harvard University and the University of Colorado, Boulder, we are concerned that FDA’s current testing authorization pathway does not provide a means by which FDA could authorize these low-cost, rapid, in-home screening devices in a timely manner for our current need. We urge the FDA to recognize frequent screenings serve a different role than diagnostic tests and give favorable consideration under current rules or create a separate pathway for this additional public health tool. 

CDC analyses[4] suggest that we are identifying only about one in ten[5] cases of COVID-19, mostly because we are testing so few people with highly sensitive but resource-intensive PCR tests. A high-frequency test would easily make up the gap in sensitivity. Ashish Jah, Director of the Harvard Global Health Institute wrote in a recent TIME[6] op-ed, “if everyone took an antigen test today—even identifying only 50 percent of the positives—we would still identify 50 percent of all current infections in the country – five times more than the ten percent of cases we are likely currently identifying because we are testing so few people.”

Until we have a widely administered vaccine or highly effective treatment for COVID-19, re-opening schools and returning our lives to normal will require an accessible testing strategy that is far broader than currently possible. The United States still tests fewer than one million people per day. Recent reports of backlogged results due to overstrained labs and shortages of personal protective equipment and testing reagents suggest that our current system is near daily capacity. A recent study from the Journal of the American Medical Association Network Open[7] finds that safely reopening college campuses this fall will require screening the nation’s nearly 20 million postsecondary students every two days. This is impossible under our current testing strategy.

We value the FDA’s work to validate and authorize Emergency Use Authorizations allowing for pooled PCR tests and diagnostic saliva-based testing, but we must have every tool available. We urge the FDA to utilize its existing authority and consider options such as providing an expedited pathway for authorization of low-cost, rapid, at-home COVID-19 screenings during this global pandemic, including paper-strip testing. Knowing with greater likelihood whether a person is transmitting the virus can influence behavior and will be key to curbing infections and reopening our economy. 

We also urge you to coordinate across federal agencies, including the Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA), to engage in a public information campaign to explain the difference between diagnostic and screening tests.

We appreciate the FDA’s hard work throughout this crisis and recognize the need for a flexible approach to taking on the current pandemic. We appreciate your attention to this critical and timely matter. 

Sincerely,

 

Ro Khanna