Some laboratories may advertise “lifestyle” or “wellness” tests that are intended to promote a healthy lifestyle, but do not make specific clinical claims or direct references to recognized diseases or medical conditions. Examples of such tests include, but are not limited to, a test to detect the best diet for a genetic profile, a test to assess risk for wrinkles and/or freckles, a test to identify the best fitness plan for your metabolism, a genetic test to determine aptitude for learning languages, a metabolic test to determine snacking profile, or a test to identity food metabolism traits.
The Department of Health does not object to a laboratory offering one of these tests, but the laboratory must comply with the applicable Department requirements. For example, the laboratory must hold a New York State clinical laboratory permit and be inspected regularly. However, the Department may opt not to evaluate these tests for the accuracy or interpretation of the results, as would generally be done for other laboratory developed tests, because the test does not make any clinical claims or direct reference to a recognized disease or medical condition. As a result, the public should be aware that such a test may not have been proven to be clinically valid.
If you feel unwell, you are encouraged to seek medical advice from a licensed healthcare provider. Note that state regulations require that all laboratory testing requires a prescription from an authorized individual, such as a licensed physician.
Below please find links to information from nationally recognized associations regarding opinions on certain tests where clinical validity has not been well established.
IgG Food Panel Testing
- American Academy of Allergy, Asthma and Immunology: The myth of IgG food panel testing
- Academy of Nutrition and Dietetics: Are Food Sensitivity Tests Accurate?
- National Institute of Allergy and Infectious Diseases: Guidelines for the Diagnosis and Management of Food Allergy in the United States
Gut Microbiome Testing
- National Library of Medicine: Microbiome 101 article 2019
- Conclusion: “There is still a long way to go before microbiome-based diagnostics become a routine part of clinical care.”
- Digestive Diseases and Sciences: Clinician Guide to Microbiome Testing 2018
- The Lancet Gastroenterology & Hepatology: Treating the individual with diet: is gut microbiome testing the answer?
Mycotoxin testing
- Centers for Disease Control and Prevention MMWR Report 2014: Use of Unvalidated Mycotoxin Tests for the Clinical Diagnosis of Illness