In 2015 the first direct-to-consumer at home genetic tests were approved, but genetic testing had been originally approved by the FDA in 2006. This is for tests conducted in a certified testing center.
Prior to that in 2013 the FDA sent warning letters to one of the largest names in at-home genetic testing by stating that they had failed to ‘assure their tests were accurate, reliable and clinically meaningful.’ After a class action lawsuit was issued against this organization, the FDA changed course two years later. This change of course was seemingly due to overwhelming evidence with clinical validity.
The history of genetic testing for preventative screening dates back to 1993 when the University of Pennsylvania used these tests to identify early stages of breast cancer. The hope was to identify early signs of potential cancer before these symptoms ever developed into cancer cells.
What Types of Direct-To-Consumer Genetic Tests Can A Senior Get?
There are four types of tests available which include
- Disease Risk and Health
- Ancestry or Genealogy
Major types of direct-to-consumer genetic tests include:
Disease Risk and Health
These tests are performed in a variety of methods including direct detection tests, linkage-based tests and genomic tests. As of 2022, these tests can identify over 2,000 different illnesses before a sign or symptom is ever seen in an individual.
Some of the most common tests are focused on identifying the types of disease listed below:
- Heart Disease
- Bipolar Disorder
- Macular Degeneration
- Other types of Cancer
These tests cannot eliminate disease in of themselves. They are a screening method that helps to identify a potential disease for preventative treatment plans.
Although we won’t be focusing on the other three types of genetic tests in this article we want to list them below so you can be aware of their benefits.
Ancestry or Genealogy
These tests help provide a direct about an individual’s ancestry, their ethnicity and possible genetic connections linking families.
This test is also known as a paternity test. This test is to identify biological connections between individuals. For example, is person A (the child) biologically related to Person B (the parent).
These tests claim to provide valuable information about daily lifestyle habits and choices. This can include but is not limited to weight loss, nutrition, fitness, sleep, etc based on DNA variations.
Diseases Risk Preventative Testing Can Save You Thousands
(Even Tens of Thousands)
It is estimated that the average senior will spend just under $6,000 in medical costs in a year when they are not dealing with significant life threatening illnesses.
This cost quickly escalates if a senior is dealing with anything beyond regular health checkups and low level health challenges. This can include but is not limited to:
- A complex inpatient surgery or procedure
- Requiring in home medical care
- In need of medical therapy or treatment for an extended period of time
For this reason, it is important to consider this preventative testing to not only prevent life threatening illness but also to consider this to prevent high medical costs due to necessary medical treatment.
Closer Look At Direct-To-Consumer Genetic Tests For Disease Risk
Regarding genetic tests that identify disease risk, there are three testing methods that are used.
- Direct detection Testing
- Linkage-based Testing
- Genomic Testing
The most common method, known as direct detection testing, is focused on the direct detection of a mutation responsible for disease.
A second less common method, linkage-based testing, is sometimes necessary and requested by a licensed medical practitioner. A test makes use of genetic markers that reside nearby a gene of interest to track inheritance of the gene in a family.
The third method, known as genomic testing, analyzes multiple genetic variants found in a gene expression to generate a “genomic fingerprint”.
According to genome.gov by the National Human Genome Research Institute (NIH) in their FAQ the benefits of genetic testing include:
- Diagnosing disease before signs or symptoms are present
- Confirming gene changes that are responsible for an already diagnosed disease
- Determining the severity of a disease
- Informing and guiding doctors to determine the best medicine or treatment to use for certain individuals
- Identifying gene changes that may increase the risk to develop a disease
- Identifying gene changes that could be passed on to children
- Screening newborn babies for certain treatable conditions
Risks And Drawbacks Of Direct To Consumer Genetic Testing
The NIH outlines a few potential concerns regarding these genetic tests.
For starters, although in 2008 Congress enacted the Genetic Information Nondiscrimination Act to protect the general public from discriminatory practices it does not apply to long-term care, disability or insurance providers.
Secondly, genetic testing is not the solution to disease. This is where the NIH states it is very concerning that a medical test is performed without consultation from a licensed medical practitioner especially in the case of illness that is already displaying signs or symptoms.
Third, they highlight privacy concerns related to data and the lack of transparency displayed by testing providers. Many who undergo these tests are not clear on how these tests could affect their current or future health care coverage as well as the financial implications of these changes.
Important Questions in Choosing The Right Genetic Testing Provider
If you are interested in direct-to-consumer genetic testing, do some research into the companies that offer these services. Questions that can help you assess the quality and credibility of a testing company include:
- Does this genetic testing provider provide information about the services offered and their testing methods?
- Is this company presenting genetics professionals who are experienced in this field, such as medical geneticists and genetic counselors?
- Does this provider include clinical and scientific evidence explaining what they are testing for and how this is linked to a disease it is testing for?
- Is the laboratory inside the United States and what type of laboratory does the testing? Is the laboratory certified or accredited by the Clinical Laboratory Improvement Amendments (CLIA) and is the test approved by the U.S. Food and Drug Administration (FDA)?
After Taking A Genetic Test
If your genetic test was done for preventative reasons for yourself, children or grandchildren it will be important to take two steps of action.
First, you’ll want to follow up with your primary care physician regarding the results of the test to determine the best preventative treatment options available to you.
Many of these preventative treatment options will be highly specialized. For this reason your primary care physician will probably refer you to a specialist who will provide you with specific guidance.
*The type of medical specialist you will see will be determined by what the test uncovered in your DNA.
Your second step will be to inform your family members, most importantly your children and grandchildren so they are aware of these potential genetic predispositions.
This is very helpful for them, because they can potentially take very important steps early in life. The preventative steps they can potentially take could have life-saving impact to keep them healthy and disease free.
If the test was taken based on a suspected disease because of your symptoms then preventative treatment will be your top priority. You will need to follow up with your primary care physician or you may need to contact a licensed medical practitioner that specializes in the suspected disease.
How Direct-To-Consumer Genetic Testing Is Administered
The process for a direct to consumer genetic test is easy to complete within two to three weeks. If you are a senior covered by Medicare Parts A and B keep in mind you cannot order a test without consent from your primary care physician. Each test will have a variety of different requirements in order to be 100% subsidized by Medicare.
Step 1 Is To Purchase A Test Kit
A direct to consumer test kit (or at-home test) is ordered via your provider of choice. It is strongly recommended that these test kits be ordered in coordination with a licensed medical practitioner that can help review the results once they have been returned.
Step 2 Is To Collect The DNA Sample
The second step is receiving the at-home test kit and collecting the DNA sample requested by the test kit. In most cases this is a swab test to collect a saliva sample from the inside of your cheek. In other cases this may require a blood sample drawn from a health clinic.
Step 3 Is To Send The Sample For Analysis
In the third step of the process, you will return the at-home kit to your genetic testing provider .
Step 4 Is To Review The Results
The final step of the test requires you to review the results of the genetic test. It is strongly recommended that you review these findings with a genetic counselor or a licensed medical practitioner.
Here is important information to consider from the FTC when considering a direct to consumer genetic test as a preventative measure.
From the FTC Fact Sheet on Genetic Testing
Link To The FTC Fact Sheet
These are two important facts to keep in mind reported by the FDA regarding at-home consumer genetic testing:
Validity of Genetic Tests According To The FDA And CDC
According to the Food and Drug Administration (FDA), which regulates the manufacturers of genetic tests; and the Centers for Disease Control and Prevention (CDC), which promotes health and quality of life, some of these tests lack scientific validity, and others provide medical results that are meaningful only in the context of a full medical evaluation.
Types of Genetic Tests
Typically, these tests require a blood sample or a swab from inside the cheek. In “at-home” tests, the sample is collected at your home and then sent to a laboratory for analysis. Prices of at-home genetic tests range from $295 to $1200.
2022 Guidelines For Medicare Subsidies On Genetic Testing
In 2022, now it is very clear what Medicare will subsidize and what they will not cover.
- The genetic test must be ordered by a doctor or ‘counselor’ who does not work for the laboratory that handles the DNA testing
- In most cases the genetic test beneficiary must directly have a history of disease, symptoms of the disease or a family history of the disease in for which the test is performed
- Some states are wholly exempt from providing coverage for some tests. For example, Medicare in the state of New York does not provide reimbursements for any genetic tests
The stipulations to receive 100% subsidized coverage by Medicare may vary from state to state and it’s always important to confirm the requirements in your state.
While genetic tests for cancer can have more stringent requirements to be subsidized other tests like diabetes have much more lenient guidelines.
In the case of a diabetes genetic test those seniors who are enrolled in both Medicare Part A and Part B will fully cover the costs if:
1. You are obese or overweight
2. Your doctor believes you may be at risk of developing diabetes
3. This does not require prior family history with this disease
Warning For Seniors Against FREE Test Scams
Recently the Administration for Community Living (ACL) has issued warnings to seniors regarding those offering free genetic testing. The ACL has found that in some cases this is a fraudulent activity.
In situations where a senior is offered a ‘free genetic test’ the Administry for Community Living has made recommendations on how handle these case by case situations.
- Always review your Medicare Summary Notice to confirm your eligibility of benefits.
- If you are offered genetic testing services from someone at a public event (IE a local fair, farmer’s market) do not accept it.
- If you receive a genetic testing kit that was not ordered by your primary care physician and confirmed by their office, do not accept it. Return it to sender without opening it.
- When asked to provide personal information (including your personal Medicare number) over the phone or via any communication channel, always confirm the person and organization you are communicating with.
Interpreting Genetic Test Results
The results of genetic tests are not always “black and white.” That makes interpretations and explanations difficult. In most cases, diseases occur as a result of interaction between our genes and the environment — for example, our lifestyle, foods we eat, elements we are exposed to such as sunlight, and tobacco.
Most genetic tests look at only a small number of the more than 20,000 genes in the human body. A positive result means that the testing laboratory found unusual characteristics or changes in the genes it tested.
Claims Of Genetic Tests
Having a particular gene doesn’t necessarily mean that a disease will develop; not having a particular gene doesn’t necessarily mean that the disease will not.
Be skeptical of claims that the tests can assess a person’s ability to withstand certain environmental exposures, like particular toxins or cigarette smoke. The FDA and CDC aren’t aware of any valid scientific studies that show that genetic tests can be used to predict whether a person can withstand environmental exposures.
We have additional articles that will help seniors understand genetic testing and its benefits.
The History of DNA Testing
Is Genetic Testing Worth It For Seniors?
Why Seniors Benefit The Most From Genetic Testing
Can Medicare 100% Subsidize Genetic Testing?