For the past several weeks, we've seen both the government and healthcare officials pleading for wide access to high-speed tests for COVID-19. That's why healthcare companies around the country have started organizing their resources to satisfy the increasing demands with direct-to-consumer testing kits.
The production of these kits can have significant benefits. They can allow various individuals to test themselves for this disease at the privacy and convenience of their homes rather than going to a healthcare center where they may infect doctors, nurses, and other people. And if a person gets negative COVID-19 results, he/she can go about their daily activities without the fear of transmitting the disease to others.
However, the road to commercializing these tests hasn't been an easy one. The FDA released new guidelines to speed up the availability of various diagnostic tests for COVID-19. With these new guidelines, laboratories accepted by the CMS (Centers for Medicare and Medicaid Services) and approved by the CLIA (Clinical Laboratory Improvement Amendments) were allowed to produce and dispense an approved test for COVID-19 for 15 days before presenting official Emergency Use Authorization (EUA) from the FDA.
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The director of the Hyman Phelps and McNamara Center, Gail Javitt, spoke to ABC News and said that the loosened rules by the FDA were not meant to last forever. She said that emergency use did not mean approval, and after the emergency was over, the distribution would stop.
Nonetheless, the relaxed guidelines gave companies and independent labs the permission to increase the production of testing kits which can then be distributed to various residences.
Various companies like Nurx and EverlyWell had already begun dispensing their home testing kits when the FDA came with a surprise notice on March 20. The FDA's notice indicated that the organization had not approved any home test kit that would be available for purchase. It also urged individuals to avoid at-home testing kits. The FDA took that action to protect consumers from unscrupulous dealers who would try to scam people with fake test kits.
The next day, the FDA issued another notice clarifying that testing COVID-19 at home, including the self-collection of samples, was not part of the EUA guidelines announced on March 16. Different companies that had been mobilizing their resources for at-home test kits are now in regulatory confusion, with many of them having ceased production.
According to Javitt, some companies that had stopped manufacturing were particularly dispensing at-home specimen collection kits. People would collect a sample at home, which would then be taken to a certified laboratory for testing. The FDA faulted that process because regular people would be the ones to collect samples whereas they weren't health care workers.
Javitt said that what companies were distributing were just collection kits, and according to the FDA, it wasn't allowed to distribute those kits for specimen collection.
Nurx, a San Francisco-based health startup, launched kits for testing COVID-19 at home on Friday. But when the FDA issued a new notice on Saturday exempting self-collection tests from EUA like the ones Nurx offers, this company released a statement indicating that they had stopped production temporarily.
EverlyWell Inc, a company based in Texas, had already started the manufacture of direct-to-consumer COVID-19 test kits and was providing them in 35 different varieties. But after FDA's new notice, the company decided to switch direction and instead of going the consumer way, they would offer their kits to healthcare centers until further notice.
A Senior Scholar at Johns Hopkins Health Security Center by the name Dr. Amesh Adalja said that many companies were cautious or worried because of the increased regulatory guidelines directed at them.
EverlyWell, Nurx, and many other healthcare companies are now confused. They're waiting to get clear information on whether they should proceed with their production and distribution of at-home test kits.
Referring to FDA's notice against at-home testing kits, Javitt said that there were competing considerations and it wasn't good for fake kits to be out there. She continued to add that at-home test kits had legitimate reasons because they would keep individuals away from public healthcare centers whether they were positive or negative.
The FDA admits that if home collection kits were accurate and safe, they would boost COVID-19 testing efforts. However, the organization said that it was working with various providers to help meet the growing demand for testing kits. Such statements indicate the COVID-19 kits may come to individual homes soon.
Adalja admits that the new FDA guidelines are somehow unclear. “The home collection kits aren't truly at-home test kits.” For instance, with Everlywell's home testing kit, you get a swab for specimen collection from your nose. However, results are not available immediately. After the specimen is collected, it's sent to an actual laboratory for testing.
According to EverlyWell, they've partnered COVID-19 labs which are CLIA-certified. Many of these labs were already offering tests for other various infectious diseases, including respiratory ones. Also, many of these laboratories were already providing COVID-19 diagnostic tests for healthcare centers.
Companies such as Everlywell have an existing capacity to offer diagnostic services, but the FDA is worried about the integrity of at-home sample collection. The organization is concerned that someone may not be able to collect specimens rightly, leading to inaccurate results.
Responding to these concerns, MicrogenDX, a company based in Texas, has presented a test that uses coughed up saliva as a specimen. ABC News interviewed MicrogenDX's CEO Rick Martin who said that the collection of a sample through the nose requires a healthcare professional because the swab needs to go in deep. However, collecting sputum doesn't need the presence of a health care worker.
This company will be launching a new service that allows a person to order a COVID-19 test kit online directly. Even though an individual can collect their sample and send it for testing, MicrogenDX says theirs is not a home collection kit - a healthcare worker must first approve the test before a patient orders it online (that is also the case with Everlywell and Nurx).
Rick Martin continues to add that where to collect the specimen is up to the healthcare worker and the patient.
Javitt says that an at-home test prescribed by a physician rather than one where you order directly doesn't fully conform to the regulatory guidelines. She said that the FDA doesn't monitor and manage the practice of medicine, they regulate products. Therefore, if a healthcare worker has decided to send a kit, it's unclear where the FDA's authority would end.
According to Rick Martin, he is not allowing patients themselves to request kits for testing. What he's doing is letting physicians request them so that they can be delivered to a patient. If someone wants to test themselves, he/she must get a signature from their physician. After physician approval, the individual gets a code that permits them to request the test kit online.
The cost for MicroGenDX’s kit would be $125, with a shipping fee of $10. Shipping samples to their main laboratory in Lubbock, Texas, would occur overnight, and patients would get their results through their physician the next morning.
Adalja says that maximum flexibility when it comes to testing is what everyone wants, but of course, everything should follow the current FDA guidelines. At-home test collection kits may be the key to achieving this, but as the healthcare sector faces an uncommon emergency, the regulations are working to satisfy its various needs.
For instance, The Bill and Melinda Gates Foundation is working on providing home testing kits for COVID-19 in Seattle - one of the locations which have been hit hard by the Coronavirus disease. It's an initiative also supported by the University of Washington, and it's meant to boost access to testing efforts and educate health workers on how this virus transmitted.
Adalja also notes that even before we experienced the COVID-19 pandemic, various professionals in the public health sector were pushing for more access to at-home testing. He says that the COVID-19 pandemic, which has been characterized by inadequate diagnostic capacity, will emphasize the need for the availability of these kinds of tests. It will lead us to the expansion of our diagnostic capacity, and also keep many people out of healthcare centers where they could crowd and possibly transmit the disease to others.