Posted: August 1st, 2020
By: James Hughes
As COVID-19 infections have spiked over the past few months, we have greater reason to focus on accurate, fast, and widespread COVID-19 testing. As of July 30th, the CDC has reported over 52 million tests with a positivity rate of 10%. However, in recent weeks, heightened demand for testing has caused increases in waiting times. On July 27th, Quest Diagnostics reported that the average wait time for non-priority tests has increased from 2-3 days to 7 days; the company’s average turnaround time for top-priority patients is just over 2 days.
Various ideas have been discussed to increase testing, such as “pool testing,” which allows multiple people to be tested for COVID-19 simultaneously through a combined “pool” of samples. If a pool test came back positive, it would indicate that at least one of the individuals in that pool may be positive, and additional testing of individual samples would be required to narrow down the results. Pool testing would be a useful tool for indicating that groups of people are unlikely to have COVID-19, and it would be especially helpful in places with low COVID-19 prevalence. Further, Dr. Anthony Fauci has recently touted pool testing, and there is some evidence to support that it may work with pools of 5 people. White House Coronavirus Task Force Coordinator, Dr. Deborah Birch, has said that pool testing could give the U.S. the ability to test up to 5 million people per day. On July 18th, the FDA issued its first Emergency Use Authorization (“EUA”) for a medical diagnostic to do pool sampling for COVID-19.
Medical device makers have been able to use the FDA’s EUA program to increase access to medical diagnostics needed in the pandemic, such as tests for COVID-19 and antibody tests. In short, an EUA allows for increased availability of unapproved medical products (or unapproved uses) during a public health emergency. However, an EUA for a specific medical product does not mean that the FDA has declared the product safe or effective, but that the potential benefits of its use outweigh the potential risks during a public health emergency and the product “may be effective,” in addition to meeting other criteria. After an EUA is given to a medical product, the FDA will continue to monitor it, collect data, and may later revoke the product’s EUA. Furthermore, the FDA has a crucial regulatory role in this testing process by balancing the need for widespread testing and the need for reliable tests.
Another idea being discussed is at-home testing that would be cheap, affordable, and provide rapid results potentially within 15 minutes (i.e., paper-strip testing). Several companies are working on similar tests, but there may be concerns about the accuracy of these tests. However, unlike other commonly used COVID-19 diagnostic tests, these in-home COVID-19 tests would not be sent to a laboratory. Nevertheless, this might raise more quality control and reliability issues. If these tests are effective and accurate, the FDA should speed up the approval process through Fast Track or allow its use through an EUA.
Additionally, another idea that has been discussed is a compulsory license for medical diagnostics to increase access to testing by encouraging greater manufacturing. A compulsory license would not allow patent holders to restrict access to their product based on permission but would award them compensation for the product’s use. Notably, the Abbott ID NOW testing device, which may provide results in as quick as 5 minutes and is available for use through an EUA, has been in high demand; and the company has shipped roughly 5.3 million Abbott ID NOW devices across the country. However, concerns have been raised about Abbott ID NOW’s accuracy. For example, one study on its point-of-care accuracy showed that Abbott ID NOW correctly identified roughly 88% of positive samples. In contrast, Cepheid’s point-of-care test, which provides results in approximately 45 minutes, accurately captured 98% of positive results.
Plus, issuing a compulsory license for a non-FDA approved medical product might not be ideal, especially when the product has not been sufficiently vetted for safety and efficacy through the FDA approval process. Further, more innovations are likely going to be made for COVID-19 medical diagnostics. Therefore, a compulsory license for a non-FDA approved medical diagnostic might result in overemphasis on an inadequate product at the expense of encouraging vital medical innovation. At this time, the interests of COVID-19 testing would be better served by allocating federal funding to ramp up manufacturing capacity, similar to the current approach for a COVID-19 vaccine, rather than issuing a compulsory license.
Additionally, it is important to keep in mind that COVID-19 is very widespread at this point. In late June, CDC Director Robert Redfield stated that it is likely that 5 to 8 percent of the entire U.S. population has been infected (either has COVID-19 or has had COVID-19). Even back in April, testing showed that 1 in 5 people in New York City had antibodies.
Therefore, it is essential to provide accurate, rapid point-of-care testing to protect our most vulnerable groups. According to the CDC, 8 out of 10 COVID-19 related deaths are from people 65 years old or older. Further, we know that COVID-19 can spread inside long-term care facilities like wildfire, and at least 41% of COVID-19 related deaths are linked to nursing homes and long-term care facilities. As the virus continues to spread, it is paramount to provide a moat around our elderly and most at-risk populations through accurate, quick, and reliable testing in addition to other safety measures. Thereby, utilizing the strengths of rapid point-of-care testing, pool testing, accurate at-home tests, and the FDA’s regulatory oversight will be indispensable in the path to fast, reliable, and widespread COVID-19 testing.
James Hughes is a second-year law student at Wake Forest University School of Law. He graduated from the University of New Mexico where he double majored in political science and history. After graduation, he plans to practice healthcare and business law.