You may recall in 2013 when Angelina Jolie had to undergo a preventive double mastectomy when doctors informed her that she had an 87% chance of developing breast cancer due to a specific gene mutation, BRCA1, that increases the risk of breast cancer. This same inherited gene mutation put her at a 50% risk of developing ovarian cancer. (2)
While Jolie’s case is an extreme reaction, her choice becomes easier to understand when you realize she lost her mother and an aunt to breast cancer. For her it was the right decision and clearly, her decision to make. More and more people are having their DNA mapped in an attempt to avoid such a fate.
People who have DNA testing done report making lifestyle changes, especially food choices.
Companies that offer genetic tests advertise that it’s a step toward a healthier lifetime. The tests offer people a guide and a glimpse into their future of how their genes could impact their health. Most of the tests are simple. You receive a packet in the mail and provide a swab taken from inside your mouth. That’s it.
The DNA testing kits are advertised as a way to manage and improve upon your lifestyle so you can enjoy a long healthy life. Of course, there are several different kits available that provide deeper insight to what’s going on inside your body.
Identifying Genetic Markers
The DNA tests are able to identify specific genetic markers that have been shown to be associated with various diseases and complex health issues and set up the right conditions to create a health crisis. (3)
The companies are quick to remind consumers that just because a person may have one of these genetic markers, doesn’t necessarily mean that they will develop the disease. The market merely indicates whether or not the person has an increased or decreased risk of developing the disease.
Some of the health conditions that a DNA genetic test might detect include:
–> Age-related macular degeneration
–> Alzheimer’s disease, late onset
–> Amyotrophic lateral sclerosis (sporadic)
–> Atrial fibrillation
–> Breast cancer (females only)
–> Colorectal cancer
–> Coronary artery disease
–> Diabetes, type 1
–> Diabetes, type 2
–> Exfoliation glaucoma
–> Leukemia, chronic lymphocytic
–> Lung cancer
–> Multiple sclerosis
–> Myocardial infarction
–> Parkinson’s disease
–> Peripheral arterial disease
–> Prostate cancer (males only)
–> Rheumatoid arthritis
–> Systemic lupus erythematosus
–> Ulcerative colitis
What Type of Person Is Ordering DNA Analysis?
People from all walks of life have ordered DNA test analyses. These people are concerned about the quality of their lives and want to know what risks they might face that could impede their health, especially as they grow older. By knowing what they are at risk of developing, they can be proactive and take measures to counter and even possibly prevent the disease from manifesting. Also, some companies point out the proven links between medications and their effects on a person’s genes.
Gene Planet states: “Based on your genetic makeup, we shall evaluate the expected response to these medications and their side effects.” The company also says that it can identify the genes that “contribute to your potential physical and mental abilities”. This information, according to the company website, can help “you direct your energy to areas where you can excel”. (4)
The company also offers a nutrigenetic analysis.
This will “identify specific needs for each individual and appropriately develop the principles of nutrition. This in effect will tell you how your body responds to specific nutrients. Along with the analysis, the company provides “preventive measures and recommendations for each disease, whenever possible.”
FDA Orders 23andme Company to Stop Selling DNA Tests
In November 2013, the Food and Drug Administration (FDA) ordered 23andMe DNA testing company to stop selling its genetic test, citing that the company was:
“Marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act).”
The letter listed the various testing, analysis and promises the company made in regards to how the analysis could be used to determine health risks, drug response and recommendations.
“Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.”
In an example of the FDA concerns, the agency states that a false positive or false negative for BRCA risk assessment could motivate a person to take drastic surgical or other medical steps or fail to take action if the real risk was overlooked. Since the company failed to respond or more important provide the FDA with the proof it had repeatedly demand be provide, it sent the warning letter. (5)
In July 2014, the FDA announced its plans for regulating DNA genetic tests and thousands of others. For the time being, the FDA has allowed the current tests on the market to continue to be sold while the agency begins reviewing all products. (6)
In September 2014, The National Human Genome Research Institute (National Institutes of Health) published “Regulation of Genetic Test”. This regulation is comprise of three federal agency oversight and control of genetic tests. (7) They include:
–> CMS (Centers for Medicare and Medicaid Services): Regulates Clinical lab for Education requirements for technicians, quality control of lab processes and proficiency testing.
–> FDA: Medical devices and test kits
–> Federal Trade Commission (FTC): False and misleading advertising
The biggest argument against genetic testing kits has been that even if a risk gene is identified, there is still no way to determine when and at what age it might create the disease it has been linked to. Even with such warnings, people are still very interested in DNA genetic testing and have continued to purchase the kits.
With the tests now being regulated, consumers should expect changes in the type of information test kit companies will be providing in the future.
References & Image Credits:
(1) TSW: Human Genetics Websites to Learn More About the Human Genome
(2) New York Times
(4) Gene Planet
(8) *B’ Cakes* via Compfight cc
(9) juhansonin via Compfight cc
(10) M Pinarci via Compfight cc