Balancing patient empowerment and quality care

The Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) recently released a position statement on direct-to-consumer (DTC) tests, which are tests that individuals can order themselves without going through a provider. DTC tests offer information on health-related matters such as allergies, sexually transmitted diseases, and even a person’s genetic makeup. In ADLM’s statement, which overhauls one that the association put out in 2019, the organization supports the use of these tests as a way of enabling consumers to gain access to their own health information and manage their healthcare.

Since the 2019 statement, the DTC test market has continued to grow, and it's set to keep expanding. ADLM’s new statement estimates that the market could be worth more than $20 billion by 2030. This growth is in part attributable to the COVID-19 pandemic, during which many people needed to be tested for the virus but couldn't always visit their medical providers. This collectively had the effect of normalizing nontraditional modes of testing such as DTC.

Now, the DTC testing market is here to stay, said Julie Shaw, PhD, FCACB, the head of the division of biochemistry at The Ottawa Hospital and associate professor at the University of Ottawa. “Direct-to-consumer testing is here,” she said. “It’s not going anywhere. So I think as lab professionals, we can either stick our head in the sand and pretend it doesn’t exist, or we can get ahead of it.”

A stake in uncertain ground

The rapid growth of the DTC test market means that ADLM’s original position on the industry had to shift accordingly. “We blew the old one up, and we started over again, because so much had changed,” said Dennis Dietzen, PhD, DABCC, FADLM, the division chief of pathology and laboratory medicine at Phoenix Children’s Hospital and chair of ADLM’s Policy and External Affairs Core Committee. Dietzen led the working group that wrote the 2024 position statement.

“The main take home message is that we think this is a good idea — under very restricted circumstances,” he said.

Indeed, the statement offers a number of recommendations for keeping checks and balances on the industry. “This position statement puts a stake in the ground that says: ‘These are the things that we need here,’ he said. “But we’re in no position to make any of these happen.”

It’s a tricky industry to provide an unqualified endorsement of. Sometimes described as a “Wild West,” DTC testing has not gone without criticism. Various offerings on the market have caught flack for a lack of proven efficacy or making misleading claims, the dubious qualifications of those analyzing the test, taking advantage of patients’ fears, and generating ethical quandaries. Some providers have tried to escape these criticisms by stating that they merely provide health information as opposed to medical advice, but they cannot control how consumers interpret and use these tests.

But DTC services do have benefits. For instance, those who live in remote or underserved areas can greatly benefit from being able to order and perform tests at home. People can get results more quickly from DTC tests compared to traditional methods. Consumers now can order tests for which they may prefer privacy, such as sexual health tests.

Cost is also a factor; Dietzen sees these tests as a way of democratizing access to testing. “We would love to see the threshold for people to use these get lower,” he said, “because frankly, access to such testing — particularly in socioeconomically disadvantaged environments — is a huge problem.” And the strongest sentiment in ADLM’s position statement is that DTC tests give people more autonomy over their health.

A difficult outlook for regulating DTC tests

That being said, there always will be fraudulent or misleading activity in this space that takes advantage of the consumer, according to Dietzen. ADLM’s statement makes numerous recommendations to U.S. regulatory bodies to try to keep this to a minimum.

For one, the Centers for Medicare & Medicaid Services should ensure that all laboratories engaged in commercial testing are CLIA certified. The Federal Trade Commission (FTC) also should vigorously prosecute providers that engage in fraudulent or misleading activity. But the sprawling nature of the market leads Dietzen to think that it’s “unreasonable to expect the FTC to keep up with the number of scams that might flourish in the marketplace.”

According to Katie Stoll, MS, CGC, a genetic counselor and executive director of the nonprofit organization Genetic Support Foundation, one of the biggest issues with DTC testing lies with the subset of these tests that are consumer-initiated but still require an order from a qualified medical provider. The loophole that is often exploited by labs that wish to increase sales through direct access to testing is to work with physician networks that will sign off on test orders “for just about anything” for a fee, she said.

She also echoed Dietzen’s concern that regulatory bodies will not be able to monitor the industry sufficiently to prevent harm to the public. The FTC, for instance, does not review marketing claims before a product is promoted to consumers, she pointed out; the organization can go after companies when they learn of false advertising, but it suffers from “a very limited bandwidth in the area of health and usually would only learn of a bad-actor lab after harm has been caused,” she said.

“In my mind, the regulators are not equipped to do this,” Dietzen said. “So it’s sort of an empty feeling when you make these recommendations, and you know that they’re not really realistic at this point.”

Outside of the United States, the rise of this industry has other repercussions. In countries with universal healthcare, such as Canada, where Shaw is based, or in the United Kingdom, there are concerns that the growth of DTC testing may be at risk of putting undue burden on these already-stretched public services.

“Inevitably, the more testing you do, the more abnormal results you’ll find, just statistically,” Shaw said. “Is that going to end up costing the healthcare system even more money?”

How lab professionals can take the lead

With all of these potential drawbacks to DTC testing, laboratory professionals have a opportunities to ensure that these tests are used as appropriately as possible and to help consumers to navigate the rocky terrain ahead. ADLM’s statement calls on labs performing DTC tests to explain the purpose of each test in an accessible and easily understandable way, detailing appropriate use, specimen-collection methods, risks, results interpretation, and cost to consumers.

The statement goes on to say that labs should provide prominent instructions for consumers to contact a qualified healthcare provider with any questions or concerns. Labs must also validate all sample collection, sample processing, and testing practices in accordance with CLIA regulations or guidance from the Food and Drug Administration.

Another issue that DTC testing raises and that lab experts can help answer is the perennial question of how much information is too much information. Although DTC tests may give consumers the opportunity to learn more about their health, they may not always be equipped to interpret the results of their tests. And clinicians also may lack the training or education needed to evaluate the results, or to incorporate the results into clinical care in any meaningful way.

This is where lab professionals can come in, said Hoda Hagrass, MD, PhD, FCAP, FADLM, who worked on ADLM’s position statement and is the medical director of clinical chemistry and immunology laboratories at the University of Arkansas for Medical Sciences.

At present, lab professionals mostly interact only with the medical community, but according to Hagrass, they will now need to be retrained to communicate directly with the consumer — and to be equipped to educate consumers accordingly. “We need to make sure that we are all built for any question that comes to us from the healthcare provider — or from consumers themselves,” she said.

Grace Browne is a freelance journalist who lives in London. She currently has a fellowship funded by the International Center for Journalists through the Health Innovation call. +Email: [email protected]