In recent days, the U.S. Food and Drug Administration's (FDA's) policy granting authorization to manufacturers and laboratories for desperately-needed COVID-19 test kits has created mass confusion and even led to the beginning of a Congressional investigation over what could be the most significant way to identify COVID-19-positive cases and save lives of both frontline healthcare workers and Americans. Meanwhile, the U.S. is behind on testing its population, with federal and state governments declaring that more testing is urgently needed.
Simplified access to COVID-19 testing, which can quickly identify people who have and do not have the virus, is essential to mitigating disease spread. Experts believe that symptoms of COVID-19 can take more than a week to manifest, meaning that the carrier may have no signals to alert them or others to the infection and continue unknowingly spreading the disease. By the time patients get access to testing, and become aware of a positive test, they have already exposed many others. Timely access to reliable and reputable diagnostic testing can help prevent and save lives. Unfortunately, despite early access to diagnostics that are critical to helping break the chain of transmission, the agency's approach to sample collection kits continues to create significant barriers to COVID-19 testing and reliable diagnoses, and is creating significant confusion to the industry that offers COVID-19 testing, with some testing being offered at no profit by companies.
How Did This Happen?
It appears that the FDA is not acknowledging the significant difference between at-home sample collection kits and at-home diagnostics. COVID-19 sample collection kits are ordered by healthcare providers to allow patients to collect their own saliva in the home. The sample is then submitted to and analyzed by a certified laboratory that renders the test result to the healthcare provider for interpretation. This process flow is a valuable tool to mitigate disease spread because at-home sample collection can help avoid the need to enter a healthcare facility for diagnosis. On the other hand, requiring a patient to enter a healthcare facility to provide a saliva sample significantly increases the risk of COVID-19 exposure to both the patient and healthcare workers. If the person is infected, entering a healthcare facility can expose at-risk patients seeking medical care. If the patient is not infected when they come in for testing, the healthcare facility can serve as a source of the virus that the patient carries home with them. At-home sample collection is therefore a critical and essential component to helping manage and contain the spread of the coronavirus on patient and population levels alike.
At-home sample collection kits are very different from at-home diagnostic kits, in that collection kits do not rely as much on the expertise of a healthcare provider. Sample collection kits are submitted to a laboratory for analysis through a healthcare provider intermediary that interprets the results. The healthcare provider then considers the results in combination with other factors such as patient history to ultimately render a diagnosis. At-home diagnostics, on the other hand, rely primarily on the patient to interpret test results.
On March 16, the FDA issued an Immediately in Effect Guidance Document titled, "Policy for Diagnostic Tests for Coronavirus Disease-2019 During the Public Health Emergency." The FDA's guidance did not preclude obtaining the test samples via a home sampling kit prescribed and issued by a licensed health provider. In fact, the FDA has historically permitted the commercialization of laboratory developed tests (LDTs), where kits could be delivered to patients at home for sample collection. Under the FDA's established policy, once the patient was prescribed the test and provided the sample using the at-home collection kit, it would then be sent to a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory for analysis. But in a surprise and unexpected move, on March 21, the FDA issued an updated FAQ on COVID-19 testing in which the agency stated that home sample collection kits were not covered by Emergency Use Authorizations (EUAs). The public is left bewildered as to why the products that can mitigate disease transmission are being stymied by the FDA's bureaucracy.
Layered atop the FDA's regression are inquiries from the House of Representatives Committee on Oversight and Reform. The Congressional inquiries have been directed toward companies that supply at-home sample collection kits but ask questions related to at-home diagnostics, thus highlighting and reinforcing the pervasive confusion between sample collection kits and diagnostic kits. Congress is thus also rightfully confused.
In the middle of a full-blown pandemic, the FDA has put the brakes on COVID-19 tests by frustrating what laboratories have been doing for years—distributing sample collection kits through a learned intermediary who orders the test and interprets the results for the patient. There is no reason why validated COVID-19 sample collection kits should not be available. Indeed, on March 23, the White House proclaimed that self-swabbing options should be available to Americans this week.
What Can Be Done?
Companies are striving to market sample collection kits that can be used by patients to provide timely diagnoses to help address the COVID-19 pandemic. However, until a clear premarket pathway (or policy of acquiescence) is established by the FDA for the distribution of sample collection kits, Americans will remain without adequate access to critical diagnostics that can curtail the spread of the disease. Regulators are implored to consider the public health toll of such an irrational and incoherent policy. While manufacturers and clinical laboratories stand at the ready to empower healthcare providers with tools to provide accurate diagnoses and guidance, Americans continue being exposed to a deadly pandemic under a failing sample collection kit policy.
Readers are urged to contact White House officials, Congress, and the FDA and express that COVID-19 sample collection kits that have been validated according to established protocol should be immediately permitted under the agency's EUA power. Publishing the EUA on the agency's website is, in turn, expected to allow companies with sample collection kit manufacturing capabilities to follow the protocol and make these sample collection kits available to first responders and patients in need, hopefully before disease spread is avoidably intensified.
