What is the Difference Between Direct-to-Consumer & Clinical Genetic Testing?

What is the Difference Between Direct-to-Consumer & Clinical Genetic Testing?

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Today, there are several different types of genetic tests out there on the market. With that, it’s easy for consumers to be confused and overwhelmed with the variety of options out there. That’s why it’s essential to educate yourself on the right one for you and your family before making the decision to undergo any form of testing.

In this piece, we’ll be uncovering the difference between two types of genetic tests: clinical genetic testing and direct–to-consumer genetic testing.

What is Direct-to-Consumer Testing?

Ever seen YouTubers or content creators making videos of themselves taking self-administered DNA test kits to discover their ancestry? These tests would fall under Direct-to-Consumer (DTC) testing, also known as at-home genetic testing.

According to the Ministry of Health (MOH), such tests are primarily used for non-clinical purposes such as guiding one’s personal well-being, determining their ancestry, and learning about their countries of origin.

While DTC tests can still detect potential health problems in the slightest amount, consumers must note that there are still limitations and inaccuracies associated with this process. The primary purpose of DTC testing isn’t to uncover health problems and complications, so consumers shouldn’t rely on this solely unless it’s for recreational purposes.

What is Clinical Genetic Testing?

On the other hand, clinical genetic testing is the exact opposite of DTC testing. These tests are run and supervised by a certified clinician from start to finish—from the genetic counselling process, analysis of results, to the potential diagnosis.

Compared to at-home genetic testing, the primary purpose of clinical testing is to assess one’s genetic background to uncover potential variants or mutations in your DNA, which explains why it’s a more complex process. The results are far more in-depth and give patients a comprehensive overview of their genetic cancer risk and the next steps.


Key Differences Between Both Testing Methods

  • Purpose for testing
  • How the procedure is done
  • Limited results
  • Privacy reasons
  • Insurance coverage


1. Purpose for testing

The thing about DTC tests is that they’re often seen as recreational tests used to uncover simple and basic results on one’s ancestry and ethnicity. They are sold and marketed to consumers through the Internet, television, and can even be purchased over-the-counter.

Meanwhile, clinical genetic testing is used to assess one’s cancer risk by understanding any potential mutations in your DNA, and can only be done at certified medical practitioners.

With that said, these tests are not meant to replace actual clinical genetic testing or visits to a healthcare provider. The most it could do in terms of detection is serve as a preliminary screen for several causes of genetic disorders. From there, you would need to visit a medical professional for any further testing.

2. How the procedure is done

More often than not, DNA genetic kits can be done in the comfort of your own home and without the need to undergo genetic counselling. These are self-administered tests that don’t typically require the supervision of a healthcare professional.

Meanwhile, genetic testing needs to be ordered by a medical professional. During the process, a licensed clinician will collect DNA using a blood or saliva sample, which will then be sent to laboratories to assess any harmful changes in the patient’s DNA.

Prior to the testing process, patients would normally undergo genetic counselling to help doctors understand their patient’s concerns and medical history in greater detail—something that DTC kits don’t come with.

3. Limited results

Ask yourself this: If you want to get tested for an inherited disease, would you rather buy a DIY over-the-counter test kit or undergo a clinically validated test procedure? Naturally, you’d pick the latter.

The danger with at-home genetic test kits is how they may produce inaccurate or limited results for those seeking information on their genetic status. Companies or vendors that sell DTC test kits often market other products as well including fitness or lifestyle products. With that, there’s a high chance the results from their test kits are not proven by clinical genetic providers to be medically valid.

Instead, visit a credible healthcare provider with a specialisation in clinical genetic testing. This way, you don’t have to worry about a sketchy test provider or inaccurate test results.

4. Privacy reasons

In Singapore, the Personal Data Protection Act (PDPA) exists to protect patients by only using your data to serve you and your medical needs.

Healthcare institutions limit your personal information only to those who are directly involved in your care, and even remove details that identify you when your data is being used internally. This is to safeguard your genetic privacy and personal data.

Just like many other medical procedures and tests, the PDPA applies for clinical genetic testing so patients can rest assured that their information is in safe hands. Unfortunately, this isn’t the case for at-home testing kits.

Since the analysis of the results is not always medically validated by qualified health care providers, there is no concrete regulatory framework in place for the distribution of direct-to-consumer kits. With the absence or lack of such regulations, it becomes easy for DTC genetic testing firms to use and manipulate consumer data without the consent or knowledge of the user itself.

5. Insurance coverage

As long as it has been recommended by a patient’s doctor, clinical genetic testing can be covered by most, if not all, health insurance policies. At the end of the day, it is a clinical procedure after all. However, it would still be best to check with your insurance provider to verify this information.

With DTC testing, individuals cannot make claims for at-home genetic tests. Since the primary purpose of such tests only includes learning more about one’s ancestry and obtaining “recreational genetic results”, it simply cannot be claimable as a medical expense.

Should You Use Direct-to-Consumer Testing for Detecting Cancer Genes?

If you simply want to find out more about your heritage and ancestry, then direct-to-consumer tests are the way to go. But if you’re looking to dive deeper and assess your cancer risk and any potential genetic disorders, clinical genetic testing remains the best option.

With the guidance and input from a genetic counsellor, patients will have the unique opportunity to learn more about their genetic disease risk and testing options, and have a professional guide them through the following steps in their care plan.

Want to get started on your genetic testing journey today? Get in touch with us and we’ll take it from there.