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At-Home Coronavirus Tests Get Nod From FDA But Agency Proceeding With Caution

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NEW YORK ─ Addressing a testing modality that many have been saying is crucial to getting more people tested for COVID-19 and managing the disease, the US Food and Drug Administration has recently ramped up its authorizations of at-home sample collection kits for SARS-CoV-2 testing.

But even as the agency has signaled a growing comfort in allowing consumers to do their own sample collection for COVID-19 testing – sometimes under the eye of a healthcare professional – concerns linger about the potential for improper use of the devices by patients, as well as technical issues around the devices.

On Friday, the FDA announced that it had added an at-home self-collection template to its SARS-CoV-2 EUA guidance. In doing so, though, the agency also said that home collection "raises unique concerns about safety and accuracy," including whether a sample can be "collected safely and properly by a layperson, [and] can the sample be shipped in a way that’s stable to ensure an accurate result once it reaches the lab, among other factors."

According to Jack Jeng, chief medical officer of at-home antibody test developer Scanwell Health, "The biggest challenge is ensuring that the test being performed by the user at home is as accurate as a test performed by a healthcare professional in the medical setting.

"Diagnostic tests, especially when performed in the home, have to meet a very high bar because of the negative consequences that false results can cause," Jeng said in an interview.

The appeal of an at-home test is obvious. There's the comfort factor whereby a patient doesn't need to leave the home to get tested. For healthy patients, at-home testing also eliminates the risk of catching COVID-19, or another illness, from another patient in the waiting room.

"Testing at home also reduces the burden placed on brick-and-mortar healthcare locations at a time when these resources are especially strained," Jeng added.

With certain equipment, such as swabs, and resources, including trained lab professionals, already strained, home-based sample collection could offer some relief as the demand for testing remains high.

During a town hall meeting held in mid-May, the FDA's Office of In Vitro Diagnostics and Radiological Health Director Timothy Stenzel said that the agency is open to new ideas for doing at-home collection and testing for the coronavirus. "We clearly expressed today and in our previous town halls" that the FDA is "looking at ways to expand authorization for home collection," and is open to home testing and over-the-counter testing, he said.

While the FDA has issued EUA to home-based sample collection kits, it has not given such designation for any test that can be done start-to-finish at home, including the actual testing. All the kits that have received EUA still require that samples be sent to a laboratory for testing.

And two months ago, the agency was concerned enough about the at-home coronavirus testing space that it had to issue a consumer alert warning people to beware of companies marketing unproven products for diagnosing, preventing, or treating COVID-19. In particular, the agency said it was aware of companies selling unauthorized kits for at-home COVID-19 testing and said it would issue injunctions against companies making fraudulent claims and seize unauthorized products.

The FDA consumer alert was enough to put the brakes on several firms that were poised to launch their at-home tests, including Nurx and Carbon Health, which quickly put their plans for such tests on hold. Neither firm responded to emailed questions for this article.

According to Nurx's website, the firm has currently "stopped all new test requests" for coronavirus consultation and testing. At Carbon Health's website, the firm said it is taking a mobile COVID-19 testing clinic to stops throughout the San Francisco Bay Area and beyond. 

Another company, Dublin-based LetsGetChecked, which had also announced plans to distribute an at-home collection kit for the coronavirus, moved forward with an FDA submission and received an EUA on Friday. Similarly, Austin, Texas-based Everlywell, which had previously announced that it would make available an at-home collection kit for COVID-19, received an FDA EUA in May.

Frank Ong, Everlywell's chief medical and scientific officer, said in an interview that its EUA represents "a defining moment" for at-home collection because a number of manufacturers and labs, if they obtain EUAs, can use its collection kit. So far Birmingham, Alabama-based Assurance Scientific Laboratories and Temple City, California-based Fulgent Therapeutics have received authorization for testing of samples using Everlywell's at-home collection kit. Additional diagnostic test manufacturers and laboratories are submitting regulatory applications aligned with use of its collection kit, and authorizations are expected soon, Ong said.

Last week Quest Diagnostics received EUA from the FDA for its self-collection kit for SARS-CoV-2 testing, and the Secaucus, New Jersey-based company said it expects more than a half-million tests that use its collection kit will be available by the end of June. Specimens are shipped overnight via FedEx at room temperature and without a frozen cold pack and may be tested using the Quest Diagnostics SARS-CoV-2 RT-PCR test that received an EUA in March.

Its main competitor, Laboratory Corporation of America, announced in April that it received an FDA EUA permitting home self-collection of samples for its COVID-19 RT-PCR test. The EUA allows patients to collect samples using LabCorp's Pixel by LabCorp COVID-19.

While most newly authorized home-collection kits use nasal swabs, the FDA has also granted an EUA for a saliva-based collection kit developed by Piscataway, New Jersey-based Rutgers University Cell and DNA Repository (RUCDR) Infinite Biologics. The decision followed a previous EUA granted to RUCDR for the first saliva-based test involving collection by healthcare workers at testing sites.

Rutgers said in a document provided to 360Dx that a fully automated nucleic acid extraction workstation at RUCDR can process up to 10,000 saliva samples per day for SARS-CoV-2 coronavirus testing. All samples are run at the Rutgers Clinical Genomics Laboratory, with results returned in approximately 48 hours.

RUCDR said that as a next step, it anticipates applying for an amendment to its current EUA that would allow for primary molecular testing on asymptomatic patients.

A second saliva collection kit associated with P23 Labs TaqPath SARS-CoV-2 PCR test received an EUA later in May. The test uses saliva samples collected using OraSure Technologies' Omnigene Oral OM-505 saliva collection device.

Meanwhile, a number of other firms and academic groups are developing different technologies for use in tests within the home, including those used for molecular tests to detect active infections and antibody tests to detect an immune response against SARS-CoV-2. They include Washington University in Saint Louis, Cornell University, Biosense Detection, University of Oxford, and Mologic.

Los Angeles-based Scanwell Health announced in early March its intention to seek authorization for use of its home-based antibody test against SARS-CoV-2. The firm is finishing up validation studies and anticipates receiving an EUA within a few weeks, the company told 360Dx.

Scanwell will launch the blood-based at-home rapid serology testing service in the hardest hit states. "As we scale up our production of test kits, we will expand to other regions," Jeng said. "We believe we have the initial capacity to supply more than 100,000 test kits per month."

Scanwell will make its rapid serology test available through Lemonaid Health, its telehealth partner, and it is exploring in-store opportunities with national retailers.

Obtaining an EUA

Seattle-based start-up Tasso, meanwhile, is developing technology to make blood collection easier for testing in laboratories. Its device adheres to the skin and collects capillary blood as an alternative to venipuncture. The blood collection kit is part of investigational studies in hospitals and reference laboratories, and the firm hopes to obtain an FDA EUA for its use with serology testing, Ben Casavant, the firm's cofounder and CEO, said in an interview.

Obtaining an EUA for at-home collection is a rigorous process. Though its EUA came in May, Ong said that Everlywell began its discussions with the FDA in early March. Discussions mainly centered around ensuring the stability of samples overall and especially during shipping, Ong said.

The firm needed to demonstrate, for example, that temperature variations would not affect samples and test results. Molecular testing in labs involving sample collection by healthcare providers had relied heavily on the use of nasopharyngeal swabs, but Everlywell and the FDA recognized that self-use of the swabs in the home could lead to injury or inaccurate results, Ong said.

As a result, its studies for at-home collection focused on the viability of nasal swabs, similar to Q-tips, that are inserted a few centimeters into the nose. Additionally, the firm tested the usability and safety of saline as a fluid in which the swabs could be immersed.

In addition to conducting its own studies, Everlywell used results of validation studies completed by UnitedHealth Group, the Bill and Melinda Gates Foundation, and others that show the usability of nasal swabs at home, Ong said.

For home collection, he added, the most important studies are those that show sample usability, stability, and durability during transportation. Overall, Everlywell used data from roughly 10 different studies, including its own and involving more than 300 positive samples, Ong said.

In response to a request for comment, the FDA directed questions to recently published documents posted on the agency's website.

The agency noted in EUA documents posted at its website on Friday that sample collection can be done in the home only when it is deemed appropriate by a healthcare provider. Further, the agency noted in its at-home collection template that firms can only offer a COVID-19 test for at-home self-collection "if at-home self-collection is specifically authorized under the EUA for the test."