Policies of US Companies Offering Direct-to-Consumer Laboratory Tests

Abstract

This qualitative study assesses the practices and policies of companies offering direct-to-consumer laboratory testing in the US.

Direct-to-consumer (DTC) laboratory tests are increasingly available to consumers with minimal or no involvement from health care professionals.¹ The DTC laboratory testing market is projected to be worth $2 billion by 2025 and includes both start-ups as well as DTC arms of established corporations such as Labcorp and Quest Diagnostics.^2,3 Such tests raise ethical issues, including appropriateness of testing, fragmentation of care, company liability, privacy of health information, and potential lack of follow-up for abnormal results.^4,5,6 To date, however, the empirical literature on health-related DTC laboratory tests has been limited in scope. This qualitative study assesses the practices and policies of companies offering DTC laboratory testing in the US.

Methods

We identified companies offering DTC laboratory tests through Google searches using iteratively developed keywords (eMethods and eFigure in Supplement 1). We conducted a content analysis of companies’ terms of service (ToS) and privacy policies, and evaluated their protocols for abnormal result delivery and health care professional involvement.

This study was carried out in accordance with all relevant ethical and legal standards, including the Declaration of Helsinki. This study was deemed exempt from review by the institutional review board of the University of Pennsylvania, in accordance with 45 CFR §46.104.

Results

Eighteen types of health-related tests were identified across the 21 companies included in the sample (Table 1). The most commonly offered tests were thyroid tests, diabetes and hemoglobin A_1c tests, and panels of tests marketed for women’s and men’s health. Most tests required the collection of blood samples either through at-home finger sticks or venipunctures performed at walk-in laboratories. Other tests involved different types of samples, such as nasal swabs, stool samples, or vaginal swabs.

Table 1. Tests Offered by the 21 Direct-to-Consumer Laboratory Testing Companies in the Sample.

Type of test/marketed indication	Example	No. (%)
Thyroid	Tests measuring biomarkers such as TSH, free triiodothyronine, free thyroxine, and thyroid peroxidase antibodies	12 (57)
Diabetes	Tests measuring biomarkers such as HbA1c and blood glucose	11 (52)
Women’s health	Tests measuring biomarkers such as estradiol, progesterone, luteinizing hormone, follicle-stimulating hormone, TSH, LDL-C, and HDL-C	11 (52)
Men’s health	Tests measuring biomarkers such as testosterone, sex hormone binding globulin, prolactin, estradiol, free androgen index, LDL-C, and HDL-C, as well as prostate screening	11 (52)
Vitamin	Vitamin B12, vitamin D, and vitamin E	11 (52)
Sexually transmitted disease	Hepatitis C, chlamydia, gonorrhea, trichomoniasis, syphilis, and human papillomavirus	10 (48)
Fertility	For women: tests measuring biomarkers such as TSH, anti-Müllerian hormone, and follicle-stimulating hormone; for men: sperm count tests	9 (43)
Inflammation	Tests measuring hs-CRP	9 (43)
Heart health	Tests measuring biomarkers such as total cholesterol, LDL-C, HDL-C, triglycerides, small dense LDL-C, hs-CRP, and HbA1c	8 (38)
Health bundles	Comprehensive bundles that test for multiple different indications such as liver and kidney heath, blood glucose, cholesterol, vitamin D, HbA1c, and hs-CRP, as well as urinalysis	7 (33)
Cholesterol and lipid	Tests measuring biomarkers such as LDL-C, VLDL cholesterol, HDL-C, and triglycerides	7 (33)
Cancer	Colon cancer screening (prostate-specific antigen) and prostate screening (colorectal cancer)	7 (33)
COVID-19	COVID-19 polymerase chain reaction test and COVID-19 antibody test	7 (33)
Metabolic panels	Tests measuring biomarkers such as ALP, ALT, AST, bilirubin, BUN, creatinine, sodium, potassium, carbon dioxide, chloride, albumin, total protein, cortisol, TSH, and free testosterone	5 (24)
Allergy	Tests measuring levels of immunoglobulin E antibodies in response to allergens related, among other things, to food allergies and indoor and outdoor allergies, as well as respiratory allergies test	5 (24)
Heavy metals	Tests measuring heavy metals, such as lead, mercury, arsenic, selenium, iodine, and cadmium	4 (19)
Kidney	Tests measuring biomarkers such as urea, creatinine, estimated glomerular filtration rate, and albumin	3 (14)
Lyme disease	Tests screening for Borrelia immunoglobulin M and immunoglobulin G antibodies	3 (14)

Abbreviations: ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BUN, blood urea nitrogen; HbA_1c, hemoglobin A_1c; HDL-C, high-density lipoprotein cholesterol; hs-CRP, high-sensitivity C-reactive protein; LDL-C, low-density lipoprotein cholesterol; TSH, thyrotropin-stimulating hormone; VLDL, very low-density lipoprotein.

Companies’ practices and policies are summarized in Table 2. All companies provided disclaimers that test results did not constitute medical advice. Many (n = 10 [48%]) clarified that their services did not establish a physician-patient relationship and that they were merely facilitating communication between individuals and health care professionals. Some companies listed potential risks, including lack of accuracy, need for health care professional follow-up, discomfort when collecting blood samples, and the possibility of receiving unwanted health information. Nearly all (n = 20 [95%]) included disclaimers of warranty and limitation of liability in their ToS regarding their services and information provided on their websites.

Table 2. Practices, Policies, and Disclaimers of Direct-to-Consumer Laboratory Testing Companies (N = 21).

Type of information	Relevant details offered by companies	No. (%)
Disclaimer	Information provided is not comprehensive medical advice	21 (100)
Risks and limitations of testsa	Test may not be completely accurate (eg, possibility of false positive or negative results, technical errors arising from sample contamination, poor sample quality, sample mix-up)	9 (43)
	Potential need for a follow-up with a health care professional	8 (31)
	Discomfort with sample collection (eg, possibility of pain, bruising, inflammation during collection of blood sample)	5 (24)
	Possibility of receiving unwelcome health information that may cause anxiety and/or stress or be life altering	4 (19)
	Privacy risks (eg, possibility that data will be shared with insurance companies or other third parties)	4 (19)
	Telehealth related (eg, telehealth clinicians are not able to examine the individual in person)	3 (14)
HIPAA compliance	Statement of HIPAA compliance	10 (48)
	Explicitly states that they are not HIPAA compliant	1 (5)
	No reference to HIPAA compliance	10 (48)
Scope of privacy policy	Encompasses information collected as the consumer uses the company’s website (eg, payment information and Internet Protocol address)	5 (24)
	Encompasses information collected through website use and health information (ie, test results)	11 (52)
	Encompasses information collected through website use, health information, and biological samples	5 (24)
Data deletion	Consumers may request deletion of their personal information	4 (19)
	Information about data deletion not provided	17 (81)
Data sharing for research	Company may share data for research and development either internally or with external organizations	12 (57)
	Information about data sharing not provided	9 (43)
Possibility of follow-up for abnormal results	Yes	18 (86)
	No	3 (14)
	If yes (n = 18), who initiates the follow-up?
	Company/health care professional	10 (56)
	Consumer	4 (22)
	Unclear	4 (22)
	If yes (n = 18), which health care professional is involved?
	Physician	9 (50)
	Nurse	2 (11)
	Health coach	1 (6)
	STD counselor	1 (6)
	Unclear	5 (28)
	If yes (n = 18), what type of consultation is offered?
	Telephone call only	5 (28)
	Telephone call or email	1 (6)
	Live video visit	1 (6)
	Unclear	11 (61)

Abbreviations: HIPAA, Health Insurance Portability and Accountability Act; STD, sexually transmitted disease.

^a Multiple codes could be applied to 1 company because all relevant details offered by companies were included for analysis.

Less than half declared compliance with HIPAA (the Health Insurance Portability and Accountability Act), and less than a quarter specified protections for biological samples (Table 2). While the majority had privacy policies for information collected through website use and health data (such as test results), some had less stringent policies limited to website data only. Only 4 companies stated that consumers could request the deletion of their data, and more than half indicated the potential use of consumer data for research purposes either internally or through third-party sharing (Table 2).

The majority of companies provided consumers with the option to follow up with a health care professional. Most mentioned that the follow-up would be initiated by the health care professional and would occur with a physician, though others stated that the consultation would involve a nurse, sexually transmitted disease counselor, or health coach (Table 2). Most did not clarify whether the consultation would occur via telephone, email, or live video.

Discussion

Results of this qualitative study highlight the dissonance between DTC laboratory testing company marketing, implying the provision of medical information, and their ToS, which state tests are for informational purposes only. Given the sensitive nature of information provided by consumers to DTC laboratory testing companies and the unclear scope of many companies’ privacy policies, there are concerns about whether data might be used for purposes beyond those that consumers anticipate.⁵ Moreover, the lack of clarity regarding health care professional follow-up may lead individuals to seek additional counsel from their primary care physicians, thereby creating challenges regarding interpretation of results and potential legal liability. This study was limited to companies offering laboratory tests analogous to those available in traditional health care settings and did not encompass the entire scope of DTC laboratory tests offered to consumers (eg, wellness tests). Furthermore, this study did not evaluate the appropriateness of offering consumers access to laboratory tests without adhering to strict eligibility requirements.

Supplement 1.

eMethods

eFigure. Flowchart depicting the process of identifying DTC lab testing companies

Supplement 2.

Data Sharing Statement