Companies are selling at-home tests that analyze bacteria in your gut and body by mail. Customers send samples and get reports suggesting diet changes or supplements. However, new research shows these tests often lack proper oversight and accuracy checks. Scientists studied these companies’ websites and found misleading claims and unreliable results. The current rules don’t require these tests to prove they work correctly or that their advice is safe. Experts say stronger regulations are needed to protect people from making health decisions based on inaccurate information.

The Quick Take

  • What they studied: Whether at-home microbiome tests (tests you mail in to check your gut bacteria) are properly regulated and accurate enough to trust for health decisions
  • Who participated: Researchers analyzed websites and practices of companies selling direct-to-consumer microbiome tests, not individual study participants
  • Key finding: Most at-home microbiome tests lack proper government oversight and accuracy testing, meaning results may be wrong and could mislead people about their health
  • What it means for you: Be cautious about at-home microbiome tests. Don’t make major health decisions based solely on their results without talking to your doctor first. These tests aren’t currently required to prove they’re accurate

The Research Details

Researchers conducted a detailed review of websites and marketing practices from companies selling at-home microbiome tests. They examined what these companies claim their tests can do and what information they provide to customers. The study looked at whether these companies follow proper scientific standards and government regulations.

The researchers specifically investigated two main concerns: whether the tests are actually accurate (do they correctly identify the bacteria in your sample?) and whether the health advice based on test results is valid (does changing your diet based on these results actually help?). They also reviewed the current government rules that are supposed to protect consumers from unreliable tests.

This research matters because millions of people are buying these tests and making health decisions based on the results. If the tests aren’t accurate or the advice isn’t sound, people might waste money, take unnecessary supplements, or miss real health problems. Understanding the gaps in regulation helps protect consumers and shows where stronger rules are needed.

This is a legal and policy analysis rather than a laboratory experiment. The researchers examined actual company practices and compared them to existing regulations. The strength of this work comes from its thorough documentation of real-world problems and clear explanation of regulatory gaps. However, it’s not a controlled scientific experiment, so it identifies concerns rather than proving cause-and-effect relationships.

What the Results Show

The research found that at-home microbiome test companies make claims that aren’t properly backed up by science. Many companies suggest their tests can diagnose health problems or that specific diet changes based on test results will improve health, but these claims lack solid scientific evidence.

The tests themselves have significant accuracy problems. They may show false positives (saying you have a problem you don’t have) or false negatives (missing problems that are actually there). This means people could get incorrect information about their health status.

Currently, these tests operate in a regulatory gray area. The FDA (the government agency that approves medical tests) has largely ignored at-home microbiome tests, treating them as low-risk wellness products rather than medical devices. This means companies don’t have to prove their tests work accurately or that their health recommendations are safe and effective.

The research also found that consumers often don’t understand the limitations of these tests. Companies don’t always clearly explain that results may be inaccurate or that the health advice is not personalized to individual medical situations. Additionally, there’s no requirement for proficiency testing—a standard way to verify that labs are doing tests correctly—for many of these companies.

This research adds to growing concerns about direct-to-consumer health tests. Previous studies have questioned the accuracy of various at-home genetic and microbiome tests. This work specifically focuses on the regulatory failures that allow inaccurate tests to reach consumers without proper oversight, filling an important gap in understanding how these products are regulated.

This study analyzed company websites and practices rather than testing the actual accuracy of the microbiome tests themselves. The researchers didn’t conduct laboratory experiments to measure how often these tests give wrong results. Additionally, the study doesn’t include data on how many people have been harmed by relying on these tests, though it identifies the potential for harm.

The Bottom Line

If you’re considering an at-home microbiome test: (1) Talk to your doctor first—don’t use test results alone to make health decisions, (2) Be skeptical of claims that the test can diagnose diseases or that specific diet changes will definitely help, (3) Understand that results may be inaccurate, (4) Don’t spend significant money on supplements based solely on test recommendations. Confidence level: High—this is based on documented regulatory gaps and known accuracy problems with these tests.

Anyone considering buying an at-home microbiome test should read this. People with existing health conditions should be especially careful, as they might make treatment decisions based on inaccurate test results. Healthcare providers should also be aware of these limitations when patients mention at-home microbiome tests. People generally healthy and just curious about their microbiome should understand these tests are not reliable enough for health decisions.

There’s no timeline for benefits because these tests aren’t proven to provide health benefits. The real timeline is for regulatory change—the researchers recommend stronger government oversight, which could take months to years to implement.

Want to Apply This Research?

  • If users have taken an at-home microbiome test, track any health changes they make based on results (diet changes, supplements, etc.) separately from other health modifications, so they can see what actually correlates with feeling better
  • Rather than relying on at-home microbiome tests, users can track general wellness habits (sleep, exercise, diet variety, digestion comfort) and see what changes actually make them feel better, without needing an unproven test
  • Monitor overall health markers (energy levels, digestion, mood) over time using the app’s general wellness tracking, and encourage users to discuss any health concerns with their doctor rather than relying on at-home test results

This research discusses regulatory and accuracy concerns with at-home microbiome tests. These tests are not currently required to prove they’re accurate or that health recommendations based on them are safe. Do not use at-home microbiome test results as your only basis for making health decisions. Always consult with a qualified healthcare provider before making changes to your diet, taking supplements, or treating any health condition. If you have health concerns, seek professional medical advice rather than relying on direct-to-consumer tests.