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                In Vitro Diagnostics

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          Direct-to-Consumer TestsIn Vitro Diagnostics Direct-to-Consumer Tests
  
  	
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Lists of Direct-To-Consumer Tests with Marketing Authorization
	Frequently Asked Questions About Direct-To-Consumer TestsIn vitro diagnostics (IVDs) that are marketed directly to consumers without the involvement of a health care provider are called *direct-to-consumer tests* (also referred to as DTC). These tests generally request the consumer collect a specimen, such as saliva or urine, and send it to the company for testing and analysis.

Direct-to-consumer testing is expanding the number of people who are able to get genetic testing of their DNA (or genome). Your genome is made up of thousands of genes that carry the hereditary information about your traits, such as eye color or height. This information is based on the arrangement of distinct molecules (also known as "bases") that make up genes. Some of these arrangements, or variants, can be used to diagnose a rare disease, provide information about a person's risk of developing disease, or other types of information. Some variants have clinical significance and may give consumers insight into monitoring their own health, or about potential disease or conditions.

Not all direct-to-consumer tests are genetic tests, though the majority on the market today are. Some measure other things, such as levels of proteins in your body, levels of toxins in urine, or levels and types of bacterial flora (referred to as a "microbiome").

Direct-to-consumer tests have varying levels of evidence that support their claims. Some direct-to-consumer tests have a lot of scientific and clinical data to support the information they are providing, while other tests do not have as much supporting data. There can also be disagreements in the clinical community about the role that different genetic variants have in contributing to disease, and new information is being learned every day. There are tens of thousands of variants and varying information available to determine whether those variants are relevant to whether a person may get a disease or condition. Not all variants that contribute to a person's risk of getting a disease or condition may be known, so it is important that consumers understand that a negative result means they still may be at risk for a particular disease or condition.

Not all direct-to-consumer genetic test companies test for the same set of variants, and therefore may provide different results for the same disease or condition. Therefore, consumers must use their judgment when ordering and interpreting their results from these tests. Consumers should consider discussing their results with a genetic counselor or a qualified health care provider to better understand the clinical relevance of the result to their own health.

FDA Oversight

Some direct-to-consumer tests are reviewed by the FDA while others are not. In general, direct-to-consumer tests for non-medical, general wellness, or low risk medical purposes are not reviewed by the FDA before they are offered. Direct-to-consumer tests for moderate to high risk medical purposes, which may have a higher impact on medical care, are generally reviewed by the FDA to determine the validity of test claims.

When reviewing tests, the FDA assesses:

Whether a test can accurately and reliably measure what it claims to measure (analytical validity);
	Whether the measurement is predictive of a certain state of health (clinical validity); and
	What a company says about their test and how well it works (claims).The FDA also looks at whether the test offers accurate descriptive information that can be easily understood by a consumer without the involvement of a health care provider. This is done by reviewing the language used to instruct users on collecting the sample and interpreting the test result report.

As a matter of policy, the FDA generally does not review some types of tests, called laboratory developed tests (LDTs), that are created and performed in a single laboratory, if they are offered to patients only when prescribed by a health care provider. These tests typically do not have the FDA's independent assurance of the analytical validity, clinical validity, or clear communication of test results.

**To date, FDA has granted marketing authorization to the direct-to-consumer tests listed in this table****.**

The FDA has mechanisms in place to work with companies to address problems with tests once they are already on the market. To report a problem with a test, please see "How to Report a Problem" below.

Types of Direct-to-Consumer Tests and their Regulatory Pathways

The FDA regulates IVDs, including direct-to consumer tests, as medical devices. The specific regulatory requirements depend on the risk classification of the individual IVD. The FDA has been proactive about streamlining the regulation of direct-to-consumer tests, while ensuring that the tests are analytically valid, clinically valid, as well as appropriate for use by a consumer without the involvement of a health care provider.

The FDA regulatory pathways for some types of DTC tests are described below. The agency is committed to working with all direct-to-consumer test companies to develop reasonable and efficient regulatory pathways for new types of clinically and analytically valid direct-to-consumer tests.

***Carrier Screening Tests (******21 CFR 866.5940******):***
These tests can be used to determine whether a healthy person carries a genetic variant that could be passed on to their potential future child(ren). These tests are for disorders where two copies of an abnormal gene variant must be present for the disease or condition to develop, meaning that each parent has one copy of the abnormal variant that could be passed on, giving the child a 25% chance of developing the disease or condition. These tests are intended to provide prospective parents information about whether they may be carriers for genetic diseases, are for use in adults of reproductive age, and produce results that should be used in combination with other available laboratory and clinical information.

Carrier screening tests are exempt from FDA premarket review, but they do need to follow specific requirements that are described in the regulation for this type of test.

***Genetic Health Risk (GHR) Tests (******21 CFR 866.5950******):***
GHR tests are intended to provide information on an individual's genetic risk for certain medical diseases or conditions. The information provided by these tests may help an individual make decisions about lifestyle choices and can inform discussions with a health care provider. The GHR tests are intended to provide genetic risk information to consumers, but these tests do not determine a person's overall risk of developing a disease or condition. In addition to the presence of certain genetic variants, there are many factors that contribute to the development of a health condition, including environmental, other genetic, and lifestyle factors.

Companies that offer DTC GHR tests are required to obtain FDA clearance prior to offering their first test. Companies may then offer most additional DTC GHR tests without FDA premarket review, provided they meet specific requirements that are described in the regulation for this type of test and are not for specific higher risk uses.

***Pharmacogenetics Tests (21 CFR 862.3364):***
Pharmacogenetics tests provide information regarding the role genetics may play in an individual's reaction to drugs. These tests inform consumers of genetic variants that may be related to how therapeutic drugs are metabolized in the body, or whether an individual is likely to respond to or have adverse reactions from certain therapeutic drugs.

Companies that offer DTC pharmacogenetic tests are required to come to FDA for premarket review and clearance. Currently the FDA has not authorized any DTC pharmacogenetic tests that predict whether an individual is likely to respond to or have adverse reactions from any specific therapeutic drug.

**The FDA has issued a safety communication****to alert the public of concerns regarding pharmacogenetic tests with unapproved claims to predict an individual's response to a specific therapeutic drug where these claims may not supported by clinical evidence**.

***Cancer Predisposition Tests (CFR 21 866.6090):***
These tests provide information about an individual's risk of getting certain types of cancer. The information individuals obtain is intended to help them initiate a dialogue with their physician about whether they should be more closely followed for developing cancer or consider preventive treatment options intended to lower your chances of getting a cancer. An individual's physician will discuss with them their family history and other factors that may increase or decrease their risk.

These tests are considered moderate to high risk and are required to come to FDA for premarket review and clearance.

***Low Risk General Wellness Tests:***
Some tests are offered for purposes the FDA considers general wellness, such as tests that predict athletic ability. The FDA generally does not review low risk general wellness products.

***Ancestry Tests***.
Some tests are used to help individuals explore their genetic ancestry. The FDA does not review these types of tests.

**To date, the FDA has granted marketing authorization to the tests listed in this table****.**

Limitations of Direct-to-Consumer Tests

While health-related reports resulting from direct-to-consumer tests are intended to empower consumers to take charge of their own health, and provide access to possibly important information, they do have some risks. Keep the following in mind when considering a direct-to-consumer test:

Follow the directions provided with the test. If you do not follow the directions carefully there is a chance the test may not work correctly.
	Talk with your health care provider about which tests might provide useful information about your health. Make sure you understand the benefits as well as the limitations of any test before use. Labeling for FDA-reviewed tests describes the appropriate uses and limitations of the test.
	Do not make any dietary or health-related decisions without first discussing your test results with your health care provider. For genetic tests, you may also consider speaking with a genetic counselor, board-certified medical geneticist, or other equivalent health care provider.
	Understand that many factors can contribute to the development of a health condition, including environmental and lifestyle factors. Genetic risk is just one piece that may contribute to the development of a disease or condition.
	Some genetic health risk tests do not report all known genetic variants that might contribute to an increased risk of disease. Even if you receive a negative result for a genetic health risk test, you should continue with regular preventative care, such as annual checkups and screenings recommended by your health care provider. A positive result should also not be used to make decisions about treating a disease.
	A positive test could be stressful and upsetting, as you may learn information that suggests you might be at an increased risk for a disease or condition. Remember that a positive result from a test does not mean that you will develop that disease or condition.
	The Genetic Information Nondiscrimination Act (GINA) prevents health insurers from using your genetic information in coverage and rating determinations. GINA also prevents employers that have 15 or more employees from requesting or using your genetic information to make hiring, firing or promotion decisions. However, GINA does not cover certain other types of insurance. Receiving a genetic testing result may impact your purchase of life, disability, and long-term care insurance.
	**Remember that direct-to-consumer tests are not a substitute for a traditional health care evaluation, including health screenings and visits to your health care provider.**For more information about direct to consumer tests, please see the Frequently Asked Questions section.

How to Report a Problem

All direct-to-consumer test users, including health care providers and consumers, are strongly encouraged to voluntarily report problems with direct-to-consumer tests directly to the FDA through MedWatch, the FDA's voluntary reporting program. Problems should be reported both to the FDA and the company whenever a consumer suspects that there is an issue with a direct-to-consumer test. Health care providers should follow the reporting procedures established by their facilities.

When submitting a report through MedWatch, please include as much of the following information as possible:

Brand of the test involved (and the catalog number, if known)
	Lot number
	Date of the event
	Whether you are the consumer or a health care provider
	Whether the company was notified about the problem
	Consumer's age
	Details regarding the problem
	Actions taken due to the test result
	Discussions with a health care provider (consumers only), if anyThe FDA will follow up on all reports submitted to MedWatch to ensure patient safety and test effectiveness.

Related Resources

FDA Safety Communication: The FDA Warns Against the use of Many Genetic Tests with Unapproved Claims to Predict Patient Response to Specific Medications
	Press Announcement: FDA Allows Marketing of First Direct-to-Consumer Tests that Provide Genetic Risk Information for Certain Conditions
	Press Announcement: Implementation of Agency's Streamlined Development and Review Pathway for Consumer Tests that Evaluate GHR
	Press Announcement: FDA Authorizes, with Special Controls, Direct-to-Consumer Test that Reports Three Mutations in the BRCA Breast Cancer GenesLists of Direct-To-Consumer Tests with Marketing Authorization

The following is a list of direct-to-consumer tests have received marketing authorization by the FDA. The direct-to-consumer tests listed below have undergone an evaluation by the FDA for accuracy, reliability, and consumer comprehension.

Test Trade Name
			(FDA Submission Number)
			**Sponsor**
			**Intended Use / Indications for Use**23andMe PGS Carrier Screening Test for Bloom Syndrome

			(DEN140044)
			23andMe, Inc.
			The 23andMe PGS Carrier Screening Test for Bloom Syndrome is indicated for the detection of the BLMAsh variant in the BLM gene from saliva collected using an FDA cleared collection device (Oragene DX model OGD-500.001). This test can be used to determine carrier status for Bloom syndrome in adults of reproductive age, but cannot determine if a person has two copies of the BLMAsh variant. The test is most relevant for people of Ashkenazi Jewish descent.23andMe PGS Genetic Health Risk Test

			(DEN160026)
			23andMe, Inc.
			The 23andMe Personal Genome Service (PGS) Test uses qualitative genotyping to detect the following clinically relevant variants in genomic DNA isolated from human saliva collected from individuals ≥18 years with the Oragene Dx model OGD-500.001 for the purpose of reporting and interpreting Genetic Health Risks (GHR):
			The 23andMe PGS Genetic Health Risk Report for Hereditary Thrombophilia is indicated for reporting of the Factor V Leiden variant in the F5 gene, and the Prothrombin G20210A variant in the F2 gene. This report describes if a person has variants associated with a higher risk of developing harmful blood clots, but it does not describe a person's overall risk of developing harmful blood clots. This test is most relevant for people of European descent.
			The 23andMe PGS Genetic Health Risk Report for Alpha-1 Antitrypsin Deficiency is indicated for reporting of the PI*Z and PI*S variants in the SERPINA1 gene. This report describes if a person has variants associated with AAT deficiency and a higher risk for lung or liver disease, but it does not describe a person's overall risk of developing lung or liver disease. This test is most relevant for people of European descent.

			The 23andMe PGS Genetic Health Risk Report for Late-onset Alzheimer's Disease is indicated for reporting of the ε4 variant in the APOE gene. The report describes if a person's genetic result is associated with an increased risk of developing Late-onset Alzheimer's Disease, but it does not describe a person's overall risk of developing Alzheimer's Disease. The ε4 variant included in this report is found and has been studied in many ethnicities. Detailed risk estimates have been studied the most in people of European descent.
			The 23andMe PGS Genetic Health Risk Report for Parkinson's Disease is indicated for reporting of the G2019S variant in the LRRK2 gene and the N370S variant in the GBA gene. The report describes if a person's genetic result is associated with an increased risk of developing Parkinson's disease, but it does not describe a person's overall risk of developing Parkinson's disease. The test is most relevant for people of European, Ashkenazi Jewish, and North African Berber descent.
			The 23andMe PGS Genetic Health Risk Report for Gaucher Disease Type 1 is indicated for reporting of the N370S, 84GG, and V394L variants in the GBA gene. This report describes if a person has variants associated with an increased risk for developing symptoms of Gaucher Disease Type 1, but it does not describe a person's overall risk of developing Gaucher Disease Type 1. This test is most relevant for people of Ashkenazi Jewish descent.

			The 23andMe PGS Genetic Health Risk Report for Factor XI Deficiency is indicated for reporting of the variants F283L, E117X, IVS14+1G>A in the F11 gene. This report describes if a person has a variant associated with Factor XI deficiency and the potential for a higher risk of excessive bleeding following trauma or surgery, but it does not describe a person's overall risk for excessive bleeding. This test is most relevant for people of Ashkenazi Jewish descent.
			The 23andMe PGS Genetic Health Risk Report for Celiac Disease is indicated for reporting of a variant associated with the HLA-DQ2.5 haplotype. The report describes if a person has a haplotype associated with an increased risk of developing celiac disease, but it does not describe a person's overall risk for developing celiac disease. This report is most relevant for people of European descent.
			The 23andMe PGS Genetic Health Risk Report for Glucose-6-Phosphate-Dehydrogenase Deficiency is indicated for reporting of the Val68Met variant in the G6PD gene. This report describes if a person has a variant associated with G6PD deficiency and a higher risk for episodes of anemia, but it does not describe a person's overall risk of developing anemia. This test is most relevant for people of African descent.

			The 23andMe PGS Genetic Health Risk Report for Hereditary Hemochromatosis is indicated for reporting of the C282Y and H63D variants in the HFE gene. This report describes if a person has variants associated with hereditary hemochromatosis and a higher risk for iron overload, but it does not describe a person's overall risk of developing iron overload. This report is most relevant for people of European descent.

			The 23andMe PGS Genetic Health Risk Report for Early-Onset Primary Dystonia (DYT1/TOR1A-Related) is indicated for reporting of the deltaE302/303 variant in the DYT1 gene. This report describes if a person has variants associated with a higher risk for early-onset primary dystonia, but it does not describe a person's overall risk of developing dystonia. This report is most relevant for people of Ashkenazi Jewish descent.23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

			(DEN170046)
			23andMe, Inc.
			The 23andMe Personal Genome Service (PGS) uses qualitative genotyping to detect select clinically relevant variants in genomic DNA isolated from human saliva collected from individuals ≥18 years with the Oragene Dx model OGD500.001 for the purpose of reporting and interpreting genetic health risks, including the 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). The 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is indicated for reporting of the 185delAG and 5382insC variants in the BRCA1 gene and the 6174delT variant in the BRCA2 gene. The report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer. The three variants included in this report are most common in people of Ashkenazi Jewish descent and do not represent the majority of the BRCA1/BRCA2 variants in the general population. The test report does not describe a person's overall risk of developing any type of cancer, and the absence of a variant tested does not rule out the presence of other variants that may be cancer-related. This test is not a substitute for visits to a health care provider for recommended screenings or appropriate follow-up and should not be used to determine any treatments.23andME PGS Pharmacogenetic Reports

			(DEN180028)
			23andMe, Inc.
			The 23andMe Personal Genome Service (PGS) is a qualitative genotyping assessment system applied to genomic DNA isolated from human saliva collected using the Oragene Dx OGD-500.001 to simultaneously detect, report, and interpret genetic variants in a broad multigene test. The assessment system is intended to enable users to access information about their genetics that could aid discussions with a healthcare provider. The 23andMe Personal Genome Service Pharmacogenetic Reports are indicated for reporting of the following variants:

			Gene
						Variant(s)CYP2C19
						*2, *3, *17CYP2C9
						*2, *3, *5, *6, rs7089580CYP3A5
						*3UGT1A1
						*6, *28DPYD
						*2A, rs67376798TPMT
						*2, *3CSLCO1B1
						*5CYP2D6
						*2, *3, *4, *5, *6, *7, *8, *9, *10, *11, *15, *17, *20, *29,  *35, *40, *41This report is for over-the-counter use by adults over the age of 18 and provides genetic information to inform discussions with a healthcare providerabout metabolism of therapeutics. This report describes if a person has variants associated with metabolism of some therapeutics, but does not describe if a person will or will not respond to a particular therapeutic, and does not describe the association between detected variants and any specific therapeutic. The PGS Pharmacogenetic Reports are not a substitute for visits to a healthcare provider. The information provided by this report should not be used to start, stop, or change any course of treatment.

Frequently Asked Questions About Direct-To-Consumer Tests

1. How can consumers use information from direct-to-consumer tests?

While direct-to-consumer tests can lead to consumers becoming more engaged in their overall health and lifestyle decisions, results from direct-to-consumer tests should not be the sole basis of any type of medical decision making as these tests provide only one layer of a bigger picture. Therefore, results from direct-to-consumer tests should always be discussed with your health care provider. In addition, these tests are not a substitute for visits to a health care provider for recommended screenings or appropriate follow-up and should not be used to determine any treatments.

2. Are direct-to-consumer tests accurate?

No test is 100% accurate. Some tests may be wrong due to an error in the test, and some results may be wrong due to an incorrect interpretation of the meaning of the result.

3. I received opposite or different results from two different companies. Why?

Different companies may test for different sets of variants, much like a store may offer different brands of products. One direct-to-consumer test company may look for one set of variants linked to a disease or condition, while a different test company may look at a different set. Additionally, direct-to-consumer tests may disagree on the interpretation on whether a variant is disease-causing or not.

Experts don't always agree and the reasons for this vary. For example, one direct-to-consumer company may have private information about a variant based on their test population that another test company does not have. Another direct-to-consumer company may use different criteria when determining whether a variant is linked to a disease or condition. It is important that consumers understand what is being tested when they receive results from different companies and whether they are testing the same genetic variant.

For direct-to-consumer genetic tests, you may consider speaking with a genetic counselor, board-certified medical geneticist, or other equivalent health care provider. If you have concerns about a particular test result received from a direct-to-consumer test company, you can report problems directly to the FDA through MedWatch, the FDA's voluntary reporting program.

4. If my direct-to-consumer test is negative, does that mean that I will not develop that condition?

Not necessarily. Many diseases or conditions may be caused by a number of factors including genetics, lifestyle, and environmental factors. Additionally, not all genetic tests are looking for all of the variants that can contribute to disease development. For example, some tests might only look for a couple of variants, even though hundreds or thousands of variants can contribute to disease development. Therefore, it is especially important to continue routine medical preventive care or recommended screenings even if you receive a negative genetic direct-to-consumer test result. Consumers should consult with their health care provider about the right steps to take following receiving results from any direct-to-consumer test.

5. If my direct-to-consumer Genetic Health Risk test is positive, what does that mean?

A positive direct-to-consumer genetic health risk test does not indicate that an individual will develop a given disease or a condition. Many diseases or conditions may be caused by several factors including genetics, lifestyle, and environmental factors. However, consumers should consult with their health care provider about the right steps to take following receiving results, including getting confirmatory genetic testing, if applicable.

6. My direct-to-consumer test indicates that I'm at risk for a given health condition, but my sibling isn't. Why is that?

People inherit half of their genes from each of their parents – giving them a completely new and unique set. Siblings may inherit different genes from each of their parents and are therefore not genetically identical (unless they are identical twins). In this situation, you may have inherited a gene with a variant putting you at risk for a disease or condition from one of your parents, while your sibling did not.

Useful Links

NIH: Direct-to-Consumer Genetic Testing
	NIH: Genetic Predisposition to Disease

                                                                                  Content current as of:
      12/20/2019
              
              
Regulated Product(s)
		 Medical DevicesIn Vitro Diagnostics

          
                        Companion Diagnostics
          Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference
          Direct-to-Consumer Tests
          Nucleic Acid Based Tests


                        Blood Glucose Monitoring Devices
          Drugs of Abuse Tests
          Home Use Tests
          Laboratory Developed Tests
          Precision Medicine
          Tests Used In Clinical Care
          Warfarin INR Test Meters
 
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