Thanks to advances in medical science over the years, doctors and patients are now able to rely on genetic tests to determine the occurrence of an array of medical issues. Genetic tests allow doctors to test the likelihood that an unborn child has a medical condition such as Down Syndrome or Edwards syndrome, or if a woman has a high risk for developing breast cancer. However, according to the New England Center for Investigative Reporting (NECIR), many of these genetic tests run a high percentage of false positives.
In the USA alone, there are over 13,000 genetic tests available. However, none of these genetic tests are required to prove to the FDA that the tests are accurate. For example, in a 2014 study by the New England Journal of Medicine, one prenatal genetic test on the market for Edwards syndrome, was found to be accurate only 40% of the time!
Inaccurate results can not only cause extreme emotional trauma, but can also lead to improper diagnoses and unnecessary treatments. In regards to prenatal testing, a patient who learns that their unborn child might have Edwards syndrome or Down syndrome may choose to end the pregnancy. According to a NECIR investigation, every false positive was found to, on average, cost the patient $775,278 worth of unnecessary treatment.
It is important to note that most of these genetic tests are done under the advisory of a genetic counselor, who is a trained medical professional that helps families select the right tests and decide on what to do with those test results. However, according to the NECIR, this is where another problem has recently begun to develop. Unlike with other healthcare professionals, companies are not required by federal law to report payments to genetic counselors. As a result, there is no real way of knowing if a particular genetic counselor has a conflict of interest with a certain test/company.
The way I see it, the FDA really needs to step in, and regulators must crack down on both genetic testing companies and genetic counselors. There should be mandatory guidelines and quality control tests that these genetic tests need to pass to be used, as well as including genetic counselors on the list of healthcare professionals that companies must report payments to. By doing the above, genetic tests will become more accurate, lead to more productive and true outcomes, and keep the evils of business out of the science.