Direct-to-Consumer Testing Companies and COVID-19

Jayun Bae, MA Candidate
April 28 2020

The Story

On April 8, the direct-to-consumer (DTC) genetic testing giant 23andMe announced that it would be launching a large-scale study of its database to investigate genetic susceptibility to severe COVID-19 symptoms. The company plans to perform genome-wide association studies (GWAS) on consenting customers in its database to see if there is a relationship between participants who had severe COVID-19 symptoms and certain genes.

23andMe is not the only DTC company that has entered the field of COVID-19 research. The company Color, a similar service that offers customers genetic insights into their cancer risks, announced that they would be launching a COVID-19 testing laboratory that would work alongside public health authorities.

Other biotechnology companies have also been converting their existing laboratories, which already have the necessary equipment and infrastructure, into testing centers. For example, genetic testing labs like Color already own the real-time polymerase chain reaction (RT-PCR) instruments used in the most common method of testing for COVID-19. Once approved as a COVID-19 testing center, a lab can then coordinate with public health authorities to receive patient samples and deliver test results.

While some DTC testing companies have shifted operations away from normal business in order to support the ongoing public pandemic response, others have been creating testing products aimed at consumers. Everlywell, a company that specializes in at-home health testing kits, became the first US company to offer an at-home testing kit for COVID-19. Shortly after the announcement, an FDA warning halted marketing and Everlywell decided to donate its stock of 30,000 tests to hospitals instead. Importantly, Everlywell still intends to bring a DTC test onto the market soon.

 

The Background

The World Health Organization (WHO) reported the spread of a novel coronavirus throughout mainland China in December 2019. In March 2020, in the face of rapidly rising numbers of cases and deaths, the WHO officially declared the highly contagious coronavirus to be a pandemic. As of April 28, 2020, there have been nearly a million cases and over 50,000 deaths in the United States, representing approximately one-third of all global cases and a quarter of all deaths. The New York Times highlighted the United States’ slow public health response and low volume of testing, which are likely major contributors to the rapid rise in cases.

The symptoms of COVID-19 include fever, cough, and shortness of breath as well as more unique symptoms like a loss of taste or smell. These symptoms can be severe enough to cause respiratory-related fatalities or exacerbate pre-existing medical issues to the point of death. However, a substantial proportion of the population experiences very mild symptoms or none at all, despite positive test results. Importantly, this variation in severity of symptoms appears to extend beyond demographic factors—meaning it is not the case, for instance, that only elderly people have severe symptoms while younger people have milder symptoms. About 50% of the infected population is asymptomatic or has extremely mild symptoms; 30% develop overt, mild-to-moderate symptoms; and 20% develop severe symptoms, often requiring hospitalization or resulting in death.

The Science

Researchers are beginning to understand how COVID-19 causes symptoms in individuals. The coronavirus attaches to ACE2 receptors, which are found on the outside of cells in the human body and normally help to stabilize blood pressure. There are slight variations in the genes that encode for these ACE2 receptors, which may explain why some people become sicker than others, and could potentially be used to predict a patient’s future response to the virus. There are already free services online that will analyze your existing DTC data to create a report about COVID-19 susceptibility.

As the name implies, DTC testing companies sell their products directly to customers, rather than a healthcare professional prescribing or performing such tests. The market has been growing since the early 2000s, and these services are now commonly utilized for both healthcare and ancestry purposes. The customer performs the sample collection themselves and sends the kit back to the company, which then performs the appropriate analysis and provides a report to the customer through an online interface. DTC companies that offer genetic information scan the customer’s genome for genetic variations associated with higher risks of developing certain diseases. Meanwhile, nongenetic DTC testing companies like Everlywell perform diagnostics and general health analyses, allowing customers to take a blood or urine sample at home and send it back to the testing company for results without involving a physician.

The high out-of-pocket costs of private tests means that only the wealthy can afford to solicit tests from private laboratories

 

Researchers have expressed concerns surrounding the issue of genetic privacy. DTC genetic testing companies could suffer hacks and breaches of genetic data, a category of highly sensitive information which cannot be changed like a credit card number or password, revealing such information to malicious actors. After the novel use of consumer genetic testing to apprehend the Golden State Killer in 2018, law enforcement has been increasingly pressuring genetic testing companies to assist in investigating criminal cases without the consent of consumers. In many cases, this use by law enforcement is not overseen by laws or regulations.

In addition to privacy, health experts have also warned of the potential for health disparities to increase as genetic testing becomes more prevalent. As an example, the prices of genetic tests and lack of insurance coverage may be exclusionary to lower socioeconomic classes, who cannot afford either DTC or traditional medical testing. This issue, in particular, is being raised with regard to testing for COVID-19: the high out-of-pocket costs of private tests means that only the wealthy can afford to solicit such tests, allowing them to skip testing queues due to their economic status.

 

The Policy

The major regulator of DTC companies is the Food and Drug Administration (FDA), which also regulates lab-developed tests, including new COVID-19 tests. The FDA has responded negatively to startups offering DTC COVID-19 testing, issuing a warning that they had not approved these at-home tests, which may be making fraudulent claims of accuracy. One of the companies warned was Everlywell; as a result, Everlywell halted all marketing of their at-home COVID-19 test kits. Due to national test shortages, long waits, and rationing of public COVID-19 tests, there have been calls to make it easier for startups to get approval and begin distributing tests. However, more actors in this space may exacerbate shortages of the components (i.e., reagents) needed to produce tests, which is a major contributor to current test shortages.

More [testing companies] may exacerbate shortages of the reagents needed to produce tests

However, the FDA has begun to issue dozens of emergency use authorizations to various diagnostic companies that offer rapid diagnostic tests for COVID-19. The key distinction is that these authorized tests are not DTC tests and still require administration by a healthcare professional. Additionally, the FDA moved to allow state governments to oversee the approval process for COVID-19 testing within their own states in mid-March. Throughout March 2020, Trump’s COVID-19 response team hinted at potential FDA approval for “self-swab” testing, which would appear to be an at-home, or at least self-administered, test kit. Trump claims to have swabbed himself in a press release, announcing that the FDA was looking “very seriously” at approving the test.

The first at-home test for COVID-19 was approved on April 20, 2020. The FDA gave emergency authorization to LabCorp, a large private testing company, to distribute tests for home use and subsequent analysis in a LabCorp facility. Like the DTC company model, the collection of the sample for these at-home tests would not be supervised or conducted by a healthcare professional. LabCorp’s test costs $119, and purchase requires completing an online survey to determine eligibility. As of April 25, LabCorp’s test is being sold in all states except Maryland, New Jersey, New York, and Rhode Island.

Notably, in terms of DTC testing companies conducting database research, the FDA and 23andMe have had a checkered history. However, 23andMe’s new research study would not fall under the purview of the FDA, which oversees products like medical devices, drugs, and foods, but does not oversee not research activities. The research 23andMe is conducting will only be performed on customers in their database who have consented to research participation and who must now answer an additional survey to be included specifically in this COVID-19 research study. In the survey, participants are asked to self-report whether they have been diagnosed with COVID-19 and whether they have recently experienced flu-like symptoms. The company plans to differentiate between COVID-19 patients and regular flu patients by comparing their results to their large database of flu data collected over previous years. The survey would be re-administered monthly, and may become more useful with the release of upcoming antibody tests that can reveal whether someone has already contracted COVID-19. If the antibody tests are successfully rolled out in the United States, they could reveal a significant portion of the population who is asymptomatic, which could improve genetic studies like 23andMe’s, potentially revealing a genetic basis for disease susceptibility.

 

The Response

The FDA’s regulations have been criticized from both sides of the political spectrum for either being too permissive or too restrictive when it comes to COVID-19 related innovations. The agency is under significant strain and pressure to act in a timely manner, processing hundreds of emergency use applications and issuing near-daily guidance. There is great demand for at-home testing kits, which provide important benefits like convenience, a lower risk of spreading the infection due to limiting in-person interactions, and less consumption of personal protective equipment. Scanwell, an American DTC testing company, has been seeking FDA approval for a rapid at-home COVID-19 test for over a month; notably, the test has already been approved by China’s equivalent of the FDA and used by millions in China. The FDA has been slow to act on cases like Scanwell’s; this lag in approving tests may have led to increased test rationing and less effective pandemic control measures.

A test is only as good as the specimen... With a poor sample, you're likely to get a false positive or a false negative

Dr. Gary LeRoy, President of the American Academy of Family Physicians

The quality of self-collected samples has been disputed by experts such as Dr. Gary LeRoy, president of the American Academy of Family Physicians, saying “a test is only as good as the specimen.” Dr. LeRoy added, “With a poor sample, you’re more likely to get a false positive or a false negative,” which could create its own public health hazards. Furthermore, the FDA warns that many lab-developed tests may make excessive promises without delivering on accuracy, although the accuracy rates of self-swab tests have been specifically investigated by UnitedHealth Group and given a green light.

While a substantial amount of attention has been given to the availability of at-home tests, less has been said about the research endeavors of the DTC testing companies. 23andMe’s study is similar to many of the proposed and ongoing studies involving large databases, such as the Finnish government’s FinnGen project and the BioBank program at the Icahn School of Medicine at Mount Sinai in New York. However, the 23andMe study is the first one coming from the DTC genetic testing industry, using consumer data rather than purely research participant data purely derived from research participants. This distinction may raise additional concerns related to the manner of data collection, which is secondary to the testing kit’s purpose of providing consumer genetic insights, and its potential impacts on the profits of private companies.

 

The Takeaway

As the COVID-19 pandemic becomes increasingly difficult to manage in the face of insufficient public health resources, it would be helpful to allow and encourage contributions from the private sector, which already performs 85% of COVID-19 testing in the country. DTC testing companies have a wealth of resources and the infrastructure necessary to contribute to research, testing, and product development. As such, the concerns about privacy, equity, and access that have been raised by the arrival of DTC companies in the COVID-19 field may be less important in the immediate future than the imminent and ongoing death toll. When the pandemic subsides, it may come to light that some of these activities, such as mass research endeavors and hasty test development, were less than ideal. However, the current path forward is not one without harms, and it is unwise to block all contributions coming from DTC companies due to the unknown harms that might ensue. If we continue to place severe restrictions on DTC testing while also failing to ensure the adequate availability and safety of in-person testing, the pandemic will not be slowed. We can see from other countries that accurate and widespread testing combined with highly responsive public health systems is critical to slowing the spread and reducing the total death rate.

The Author

Jayun Bae, MA Candidate

Assistant Editor for Health @ SciPol.org

Researchers around the world have begun investigating a genetic basis for COVID-19 susceptibility; thus, it is natural that big players in the DTC genetic testing space would want to become involved. With hundreds of biotech companies joining the race for diagnostics, therapeutics, and vaccines, there are some that seem out of place. For instance, Vault Health, a company that normally sells testosterone, attempted to get a COVID-19 saliva test onto the market. However, for DTC diagnostic companies like Everlywell or a genetic data giant like 23andMe, the shift in focus to COVID-19 seems more natural and makes good use of their existing advantages and experience in the field. In a country where doctor-ordered genetic and diagnostic testing is extremely expensive, it is unsurprising that a robust industry has risen out of the promise that consumers can avoid going through healthcare professionals for diagnostic information. Even though the Families First Coronavirus Response Act ostensibly made COVID-19 testing is  to be free with insurance or government coverage, thanks to the , the implementation of this coverage is spotty, saddling some with expensive hospital bills. A cheaper at-home version could be a boon for people in lower socioeconomic classes, who have been deterred from seeking testing or treatment due to cost.


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