The Best Home Water Testing Kits of 2025 – SimpleLab Tap Score

Whether you are buying a new home, expecting your first child, or are a homesteader, one thing is probably top of mind: Is my tap water safe to drink? Using the right home water testing kit gives you the information you need to ensure your water is safe and help you find the best treatment options. When it comes to the best home water testing kit, you want to make sure it’s testing for the contaminants appropriate to your unique situation—without any tricks or gimmicks to sell you sponsored water treatments.

APC Med supply professional and honest service.

This ultimate guide to the best mail-to-lab water testing kits for your home will help you find the lab-certified drinking water test kit that's right for your needs. Below, you’ll find the best water testing kits for:

• Home Owners
• Expecting Parents
• Renters
• Specific Contaminants:
  • PFAS
  • Nitrate
  • Microplastics
  • Heavy Metals
  • VOCs
  • Pesticides
  • Bacteria, Mold & Microbiology
  • Radiation
  • Chlorine, Hardness, pH, & more
• Testers on a Budget
• Unforeseen Circumstances
• Everything!
• Closing Thoughts: Need Help or Advice?

Best Water Testing Kit for Home Owners

Tap Score Recommends: Advanced City Water Test, Extended Well Water Test

Getting the most thorough testing possible is the safest choice for avoiding longer-term water issues in a new home.

Public Water Systems

For homes that will rely on a municipal water supply, remember that local water quality information can only reveal what’s in city water before it reaches the house. Plumbing can also be a source of water contamination—especially lead. 

Houses built before the ban on lead plumbing are more likely to contain lead pipes and solder.[1] Fixtures and faucets purchased before can contain up to 8% lead.[2] Additionally, PVC pipes made before can leach cancer-causing vinyl chloride. 

If you’ll be hooked up to a city water supply, you can get the full baseline of your potential home’s water quality with the Advanced City Water Test. This city water test kit covers any metals, minerals, and chemical compounds that can damage your plumbing over time or cause long-term health effects.

Private Well Owners

If your new home has a private well, you’ll want to look into well water analysis kits. Thankfully, Tap Score offers award-winning water test kits for well water in any scenario.

Annual testing for nitrates and coliform bacteria in well water is a highly recommended practice for all private well owners. Additional testing is strongly encouraged by most state governments because groundwater may be exposed to a range of natural and human-made hazards including coliform bacteria, organic compounds, inorganic contaminants like heavy metals, and radiological particles. 

Because the EPA and local health agencies do not regulate or monitor private well water, it’s the owner’s responsibility to invest in a well water test and maintain any treatment systems to keep their water safe. 

If you’re just starting out or have never tested you well before, go for the most comprehensive baseline. The Extended Well Water Test provides well water analysis for over 180 contaminants.

Some contaminants should be tested more often than others. We have guides to help well owners understand the maintenance demands and the best well water test kits for every occasion.

The Ultimate Guide to Well Ownership & Maintenance
The Ultimate Guide to Well Water Contaminants
How Do I Test My Well Water in a Lab?
How Does Agriculture Pollute Private Wells?

Annual Well Testing

Tap Score Recommends: Essential Well Water Test

The Essential Well Water Test is an affordable option for yearly, certified lab testing that includes basic chemistry; heavy metals, nitrates and other inorganics; and coliform in well water.

It’s often also a good idea to test for other local pollutant risks near your property—like contaminants from agriculture, industrial sites, and septic leakage. To check for these contaminants (or after any sudden changes in your water quality) we suggest upgrading to the Advanced Well Water Test.

Well Testing Every 3-5 Years

Tap Score Recommends: Advanced Well Water Test 

The Advanced Well Water Test kit tests for basic chemistry, metals and other inorganics, coliform, and E. coli bacteria, plus volatile organic compounds (VOCs)—particularly those common to land-use risks like oil and gas related spills and solvents, as well as some pesticides. 

Well Testing Every 5-10 Years

Tap Score Recommends: Extended Well Water Test

We recommend repeating the deep dive with the Extended Well Water Test—including everything in the Advanced Well Water test plus more esoteric contaminants like radionuclides and an expanded panel of industrial chemicals (semi-volatile organics, plastics, pesticides, and more)—every 5-10 years.

Best Water Testing Kits for Home Loan Requirements

If your state or home loan provider requires testing your private well before selling, purchasing a new home, refinancing, or otherwise requiring a mortgage, this is likely the kit for you. 

This popular, certified home water testing package includes all laboratory analysis required by VA, FHA and USDA Minimum Property Requirements.[3]

Note: We do suggest that you confirm with your county or loan officer in case there are any additional sample handling or specific local certifications required.

Quick Guide: Best Water Test Kits for New Homeowners

Best Water Testing Kits for Homesteaders

Tap Score Recommends: Advanced Spring Water Collection

Water supplies that come from sources like natural springs or surface water are more prone to a range of contamination than groundwater from a drilled well.[4] Most springs used for drinking water need a continuous disinfection system to make sure that the water is safe. Accurate testing can pinpoint the most cost effective treatment options for your home and check that these systems are working to keep your drinking water safe.

The Advanced Well Water Test can also help you find the optimal treatments and filters for your homestead’s alternative water. This kit checks for all the general water chemistry, metals, non-metal inorganics, volatile organics, and coliform bacteria. If your homestead is supplied by groundwater from a drilled well, this kit is specifically tailored for wells.

Best Water Testing Kits for Rainwater Collection

Tap Score Recommends: Rainwater Testing Collection

Rainwater can be a sustainable alternative water source with proper testing and maintenance, especially for homesteaders, preppers, and survivalists. Frequent monitoring is crucial because rainwater is susceptible to contaminants like metals, pesticides, bacteria, viruses, and parasites.[5]

States that promote rainwater harvesting, like Texas, advise testing quarterly if the water is used for drinking—especially for bacteria, metals, and pesticides.[6]

Best Water Testing Kit for Vegetable Gardens

Tap Score Recommends: Essential City Water Test or Essential Well Water Test

Depending on your source water, either of our Essential tests will cover many contaminants and physical properties that may affect the health of your vegetable garden. 

Just like water carries the vital elements throughout a plant, it also may carry contaminants that lurk in the water supply. Increasing evidence not only suggests that contaminated water causes nutritional imbalance within plants, but links to increased foodborne illnesses from microbes, parasites, and viruses in humans, particularly leafy greens.[8-10]

Best Water Testing Kit for Expecting or New Parents

Tap Score Recommends: Advanced City Water Test, Advanced Well Water Test 

Image credit: Unsplash

Testing your water is an important step for preparing your home to give your baby a healthy start. Babies drink more water for their size than older children and adults, and their growing bodies have a hard time getting rid of toxic substances.[7]  

Expecting a Child? New Parents' Guide to Water Safety 

Choosing the most accurate test depends on where your water is coming from:

Public Water Systems

If your drinking water comes from a municipal water utility, our Advanced City Water Test will help assure you the plumbing in your home isn’t adding lead, plastic chemicals, and other pollutants to your water—especially in the taps you use for drinking or preparing formula.

Private Well Systems

If your drinking water comes from a private well, our Advanced Well Water Test covers everything that can be harmful to your baby's health and development—including coliform bacteria, nitrate, arsenic, lead, and manganese.

We also have an in-lab nitrate water test, as nitrate is a particular concern for expecting parents and infants. More in specific contaminants below.

Best Water Testing Kit for Renters

Tap Score Recommends: Essential City Water Test, Essential Well Water Test 

If you live in a home or apartment connected to a municipal water system, you—or your landlord—should receive an annual summary of contaminants reported by your water utility. 

Our Essential City Water Test is a great tool for comparing this information against the water quality after it has gone through all the pipes in your rented home or apartment. These differences can be especially significant in older buildings where the plumbing might be introducing contamination.

Disinfection Byproducts

If you are concerned about your local utility’s use of chlorine—and resulting disinfection byproducts like trihalomethanes (THMs)—the Advanced City Water Test can help monitor these contaminants in your tap water. 

If you have received a notice about haloacetic acids (HAA5) in your local water supply, you can test for them with our Haloacetic Acids Water Test:

Disinfection Byproducts: Trihalomethanes and HAA5 in Drinking Water 

Private Wells

Renters of a property supplied by a private well should thoroughly review their rental agreements to confirm who is responsible for monitoring and testing the well. If you are in charge of your rental’s annual well testing, the Essential Well Water test is an affordable way to get a baseline picture of your rental home’s water quality:

Renters' Quick Guide to Water Testing & Filtration

Best Water Testing Kits for Specific Contaminants

Along with our award-winning, comprehensive core kits, Tap Score offers the widest range of specialized test kits for particular contaminants and parameters. Already completed a baseline test and want to get some insight on specific contaminants? Curious about a contaminant you’ve read about recently? Below, you’ll find a selection of tests specialized for specific contaminants and parameters.

PFAS, PFOS, PFOA & GenX Testing

Tap Score Recommends: GenX and PFAS Test 

Per- and polyfluoroalkyl substances—or PFAS—have been in use in a wide variety of consumer goods and industrial applications for decades. Now, PFAS in water supplies is becoming a major problem across the country.

Tap Score offers different types of PFAS testing kits in accordance with the EPA’s methods for laboratories to test for PFAS in drinking water.

The broad screen test helps identify if elevated PFAS levels are worth concern, but its higher reporting limits mean this screening method might not catch trace amounts of certain compounds as effectively as our other PFAS test kits.

Remember: Because PFAS testing is highly specialized, collecting a test sample requires extra care and attention to detail. Cross-contamination is extremely easy, impacting the reliability of test samples.

Learn How to Test Your Water for PFAS

Nitrate

Nitrate (and nitrite) in drinking water supplies can pose serious health risks, especially for infants and pregnant people, and is typically more of a problem for well owners.

Our Well Water Test Kits (covered above) include nitrate testing along with other analytes integral to safeguarding well water supplies.

Microplastics

Microplastics are tiny plastic particles, technically defined as larger than 1 micron (1 μm) and smaller than five millimeters (5 mm) in diameter—or the size of a sesame seed. Microplastics in drinking water are a contaminant of emerging concern. Tap Score’s microplastics testing kits can detect down to 1 micron.

Are Microplastics in My Drinking Water?

Heavy Metals

While lead is the most widely known of the hazardous heavy metals that can be lurking in your drinking water, there are other harmful metals worth investigating. Many of them cannot be seen, smelled, or tasted.

The Lead and Copper water test offers targeted testing of lead (Pb) and copper (Cu) in drinking water. It includes an on-site DIY test strip for pH measurement, as pH can be a crucial indicator of overall water quality and is particularly valuable to know when configuring water filtration and treatment solutions.

Heavy metals are always included in all of Tap Score’s core kits.

Heavy Metals Everyone Should Test For

Volatile Organic Compounds (VOCs)

VOCs are a group of chemicals used everywhere from industry, agriculture, transportation, and in day-to-day household products. They are also a common hazard of natural or man-made disasters. Tap Score’s VOCs in water test kit tests for 60 analytes according to the EPA’s certified lab method 524.2.

The VOCs Water Test includes testing for a range of disinfection byproducts (DBPs) as well.

Semi-volatile organic compounds (SVOCs) are a broad group of moderate volatility substances that can be found in pesticides, plasticizers, flame retardants, furnishings, personal care products, electronics, and cleaning agents.

Note: Because VOCs can leave water for air, sampling requires that no headspace is left in sample bottles. Headspace refers to space in the sample container above the water itself, i.e., you didn’t fill the container all the way to the top. This can result in concentrations measured in the water being artificially low.

Pesticides

Interested in pesticides alone? While many common pesticides (which includes herbicides, fungicides, insecticides and more) are VOCs, you can target common pesticides in drinking water—such as atrazine, simazine, and methoxychlor—with our pesticide mail-to-lab kits. This can be very useful if you have a private well and live near industrial agriculture operations.

Tap Score also offers a specialized glyphosate water test kit so you can assess possible levels of glyphosate in well water.

How Does Agriculture Pollute Private Wells?
 

Contact us to discuss your requirements of Test Kit Manufacturer. Our experienced sales team can help you identify the options that best suit your needs.

Bacteria, Mold, & Microbiology

Tap Score Recommends: Total Microbiology Water Test Kit 

Water typically contains all kinds of bacteria and other microorganisms, even if it was disinfected. Most of these organisms are harmless so there’s no cause for alarm, but for certain people, especially those who are immunocompromised, it can be very important to test water for bacteria and the full range of microorganisms. Our Total Microbiology Water Test Kit identifies species of various bacteria, algae, fungi and protozoa, as well as tests for pollen spores.

Pathogens that Contaminate Drinking Water

Remember: Public water systems are treated specifically to inactivate bacteria.

The heterotrophic plate count, or HPC, is a testing method used to measure the presence of bacteria in foods, water, and water treatment systems. In simplest terms, almost all pathogenic bacteria are heterotrophic, but not all heterotrophic bacteria are pathogenic. HPC is typically used to detect major changes in a particular water source or system—HPC should stay relatively consistent so if repeat tests are showing large variation in HPC, there may be something wrong.

After a flooding event, anytime you notice a musty, mildewy, or moldy taste in your tap water, or spot a slimy, biofilm buildup on your fixtures, we recommend our targeted mold testing kit for a variety of fungal contamination.

Those with private wells are responsible for every facet of the drinking water—including maintenance, testing, and treatment. One of the ways to sterilize your well water is via a process called shock chlorination.

Shock Chlorination: Quick Guide to Disinfecting Your Well Water

Note: Testing for coliform bacteria is always included in Tap Score’s Well Water Core kits (covered above).

Radiation

Tap Score Recommends: Radiological Testing Collection

Some drinking water sourced from groundwater may contain radon—a radioactive gas—or other radionuclides like uranium or radium. If you live in an area with high uranium levels, radon levels, or other sources of radionuclides in the water, then we suggest at least an occasional water test to check that risk levels are low. Our Radiological Testing Collection offers a suite of kits for various types of radioactive elements.

Radioactive Contamination in Tap Water Explained 

Chlorine, Hardness, pH, and H2S

As we mentioned when we compared lab tests and test strips, do-it-yourself water test strips can be useful for a select few analytes, including pH, an integral water chemistry parameter. 

Your water’s pH impacts everything from the taste of your water to your plumbing health and water filtration needs.

Chlorine test strips can also be useful for gauging chlorine levels (good for pools and spas as well):

Picking up on that rotten egg smell? Hydrogen sulfide gas could be the culprit:

Curious about your water hardness? Consider this water hardness test kit that targets hardness levels more reliably than hard water test strips if you’re seeing the signs of hard water (like white residue on glasses) or experiencing its more annoying effects (scale buildup in pipes or appliances).

As a reminder, all of these and more are included along with other contaminants and parameters in our core mail-to-lab testing kits.

Best Water Testing Kits on a Budget

Tap Score Recommends: Essential City Water Test or Essential Well Water Test

Our Essential Test Kits for both city and well water are great budget-friendly options for checking in on your baseline water quality and include shipping BOTH ways.

The Essential City Water Test kits cover our minimum recommended safety standards for utility-supplied drinking water and come with a detailed Tap Score Report detailing important aspects of your household tap water, including physical properties—pH, TDS, alkalinity, and hardness—heavy metals and anything else that may impact health or the color, taste or odor of your water.

Meanwhile, the Essential Well Water Kit is designed to target the most harmful and common contaminants found in groundwater. Both Essential water testing kits include analysis for lead, copper, arsenic, water hardness, and much more.

If you’re concerned about PFAS, it can be tough to find an affordable testing option as most PFAS tests are quite expensive. The EPA PFAS test is a broad screen of PFAS compounds that is less expensive (and somewhat less sensitive) than the more comprehensive PFAS tests covered above. PFAS testing is specialized and not yet offered as a part of any core kits.

Water Testing During Unforeseen Events

Tap Score Recommends: RUSH water testing kits

Accidents happen. And so do disasters. Sometimes, you need a water test fast. But when serious health consequences are on the line and you’re dealing with more esoteric contaminants (like benzene or vinyl chloride, for example), test strips absolutely won’t cut it. You need to know your test kit will provide results your life can depend on.

For faster laboratory turnaround—particularly useful for victims of natural or man-made disasters, like floods, wildfires, or chemical spills (including PFAS)—Tap Score offers faster turnaround through its RUSH water testing kits.

The Most Comprehensive Test Kit You’ll Ever Need

For the completist, the single most extensive mail-to-lab test kit for home water analysis.

While no water testing kit will ever be truly exhaustive (there are nearly infinite chemicals, contaminants, and microbes on the planet), this test water analysis test kit includes core tap water parameters for both regulated and regulated contaminants that can pose health risks, aesthetic issues, and other overall quality and safety concerns—over 350 analytes tested! 

Unprecedently comprehensive, this water test kit offers all of the most popular Tap Score testing packages in one go.

Not Sure Which Water Test You Need? Ask Us!

The New York Times’ Wirecutter named our Advanced City Water Test the “best water quality test kit for your home.” [12]

When compared with other highly-rated kits, Tap Score tests not only offer accurate results for over different contaminants and parameters, but also include:

• An easy-to-understand report of everything tested and detected in your water
• Explanations of all potential health risks
• Unbiased recommendations you can put into action for treating your water 
• Online support from professionally certified water science engineers and experts

When Should I Test My Water?

Now—you should test your water today. Especially if you’ve never tested your water before. Tap Score has tests available for almost any contaminant situation you might find yourself in— from slimy fixtures and mysterious smells, to failing appliances and water-related illnesses. 

If you want to know more about your water quality, we’re your one-stop shop. You can also use our blog as a powerful resource for a host of testing scenarios, in-depth contaminant guides, and filtration tips.

When Can You Trust Water Filter Reviews? A Guide to Red Flags

More Information:

• Lists of Direct-To-Consumer Tests with Marketing Authorization
• Frequently Asked Questions About Direct-To-Consumer Tests

In 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.):
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.):
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.):
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.):
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 any

The 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 Genes

Lists 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.

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.

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