Since the start of the COVID-19 pandemic, one of the most frequent concerns raised by government officials, healthcare workers, and the public has been a shortage of testing kits. Even as hundreds of drive-through testing centers opened nationwide and tests have become more widely available for medical workers on the front lines, long wait times and high demand have resulted in a widespread backlog of pending test results. Lots of folks would like to get tested but understandably remain hesitant to venture out.
The good news is that many people can now obtain a coronavirus test and access your results within one to two days -- without leaving home. Everlywell, a provider of various at-home lab testing services, just released a COVID-19 test available for purchase at $109 per collection kit. Provided you meet certain eligibility criteria, you can order your at-home coronavirus test kit through Everlywell's website and receive it within one to three days. You'll have a diagnosis in hand no later than 48 hours from the time you submit your test results to the lab.
Here's what you need to know.
Who is eligible to order Everlywell's COVID-19 home test kit?
Everlywell is only making its COVID-19 home test kit available to individuals who meet the guidelines established by the Centers for Disease Control and Prevention (CDC). Anyone who wishes to purchase a test must first answer a series of online questions to determine if they qualify. Individuals who have been in close proximity to a person infected with the coronavirus, or who reside or work in an area where groups of people gather, may meet the eligibility factors for testing.
You may also qualify to purchase a test if you are suffering from moderate symptoms associated with COVID-19, such as fever, chills, body aches, shortness of breath, and nasal congestion. You must be at least 18 years of age to purchase Everlywell's COVID-19 home test kit and test kits are not available for residents of New Jersey, Rhode Island, Maryland, and New York.
How do Everlywell's COVID-19 home test kits work?
If you qualify to purchase Everlywell's coronavirus home test, you can have the kit overnighted to your home. Otherwise, you'll receive it within three days of placing your order. Once you receive your collection kit, you register it through the Everlywell website with an ID that allows the lab to process the test results. The test is self-administered via a nasal swab and comes with a tube, absorbent sheet, and biohazard bag to store the sample in and send it to the lab.
After you perform the nasal swab, you drop the sample off at the dropbox location for the carrier specified on your prepaid return label, which is either UPS or FedEx. You'll find out whether you have a positive or negative result within two days of the lab's receipt of your test kit. In total, the timeline from purchasing the collection kit to getting the result is anywhere from three to five days.
Everlywell's at-home test kit does not detect the presence of antibodies. It only determines whether someone is positive or negative for the single-stranded RNA genome found in the coronavirus, which causes the disease COVID-19. If the test produces a positive diagnosis, Everlywell includes a telehealth consultation in the $109 test kit price to help the individual determine how to best proceed with treatment.
Is there a limited supply of tests available?
Yes. There is a limited supply of tests, and Everlywell is restricting the purchase of tests to one per household. Everlywell is increasing the number of tests available. The increased availability of tests in the future hinges on wider movement in the chain of distribution, as manufacturing capabilities worldwide have been greatly impacted by the coronavirus pandemic.
Are Everlywell's at-home COVID-19 tests FDA-approved?
The U.S. Food and Drug Administration (FDA) issued Everlywell an emergency use authorization (EUA) in mid-May, which is different from an FDA approval. The FDA said on May 16:
Everlywell's kit is authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a healthcare provider. This allows an individual to self-collect a nasal sample at home using Everlywell's authorized kit. The FDA has also authorized two COVID-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the EverlyWell COVID-19 Test Home Collection Kit. These tests have been authorized under separate, individual EUAs.
Everlywell is partnering with labs nationwide that meet the regulatory and safety standards of certification through the Clinical Laboratory Improvement Amendments program. Each person's nasal swab sample will be carefully reviewed by a board-certified doctor in their state of residence before the final test results are approved and sent off.
Just what is Everlywell, anyway?
Founded in 2015 and based in Austin, Texas, Everlywell is a privately held, venture capital-backed digital health start-up that has risen to increased prominence over the past few years. Everlywell offers a wide variety of at-home testing services, including food sensitivity, fertility, Lyme disease, hormonal, and heavy metals tests.
So far, Everlywell has completed five funding deals to date, with over $55 million raised over the past five years since its founding. The company is currently valued between $100 and $500 million, according to PrivCo. In 2017, Everlywell's founder and chief executive officer Julia Cheek secured a cool $1 million of angel investor funding from Shark Tank's Lori Greiner. In return, Greiner obtained a 5% interest in the company.
Everlywell's last funding transaction occurred in April 2019, when it acquired $50 million in financing in a Series B round spearheaded by existing investors Highland Capital Partners and Goodwater Capital. Everlywell has also been backed by several other venture capital firms, including NextGen Venture Partners and Next Coast Ventures.
Potential investors have been chomping at the bit at the prospect of the Everlywell conducting an initial public offering (IPO) in the wake of the company's move to start selling COVID-19 test kits. As of now, though, the company has not indicated any plans to go public.
The next 23andMe or the next Theranos?
Digital health start-ups have piqued notable interest in the investment community in recent years. With the ever-increasing confluence of health and technology, consumer genetic services have carved a unique niche in the age of digital medicine. At the same time, it's no secret that for every successful digital health start-up, there's a long line of failures behind it. The infamous breakdown of now-defunct health tech start-up Theranos is one example that comes to mind.
Why is this?
With many digital health companies, the initial novelty inevitably wears off, and consumer demand peaks. Sometimes the company's ability to keep up with the changing needs of its customers wanes, or, as in the case of Theranos, doubts concerning the efficacy of its products creep in and erode consumer trust. This creates a quandary for investors and sometimes signals the beginning of the end for a digital start-up.
The consumer genetics market in particular has experienced a decline in recent years. The reason could be a drop in consumer demand. One of Everlywell's top competitors, 23andMe, made sweeping layoffs of 14% of its workforce in January, and Ancestry laid off 6% of its employees in February. In the wake of COVID-19, however, both companies have expanded their services to meet the growing needs of consumers and healthcare professionals by launching in-depth DNA studies, hoping to crack the genomic code behind the virus.
Everlywell has fared well in the ever-fluctuating digital health space so far with its diverse range of testing services. Its latest move to provide quick and straightforward at-home COVID-19 tests is excellent news for the American public and makes the prospect of an IPO even more attractive to potential investors. While Everlywell hasn't made any definitive announcements to go public, it's highly possible that this company could enter an IPO at some point in the next few years. In any case, this digital health company is one to watch.