Genetic-based tests are becoming more accessible to the public, but who is responsible for ensuring that the tests are accurate and based on legitimate scientific findings?

Companies such as 23andMe (https://www.23andme.com) have been delivering direct-to-consumer services on analysis of genetic variants, with a disclaimer stating that, "The tests are not intended to diagnose a disease, or tell you anything about your risk for developing a disease in the future." However, other companies are moving forward on marketing genetic tests that claim a precise diagnostic value.1

This specific group of diagnostic tests, called laboratory-developed tests (LDTs), are designed, manufactured, and used within a single laboratory. One example is Proove Biosciences (https://www.proove.com/test-menu/), a California-based company that is marketing an opioid risk profile that it claims can predict which patients will become addicted or misuse opioid prescriptions with 93% accuracy.

However, the science behind the tests, and more importantly, the claims Proove Biosciences makes with regard to the accuracy of its tests and potential consequences on patients and families, have come under fire. In addition to the opioid risk test, Proove offers these panels: addiction risk, pain perception, medically assisted treatment (MAT), epidural with fentanyl, opioid response, fibromyalgia, temporomandibular disorder, thromboembolism, psychiatric risk and response, and opioid-induced side effects.

The company also offers drug metabolism, opioid response, nonopioid response, and nonsteroidal anti-inflammatory drug risk profiles while promising that 20 additional tests are on the way.

Although the range of tests is alluring, each one comes at high price, and there are many overlapping genetic variants among the tests. The addiction risk profile evaluates 14 genes involved in brain reward pathways to assess genetic risk markers for alcohol, cocaine, heroin, nicotine, and methamphetamine use and provides medication recommendations for treatment.

In contrast, the opioid risk profile evaluates 12 genes and asks patient screening questions that include history of alcoholism, illegal drug use, prescription drug abuse, mental health disorders, depression, and age between 16 and 45 years. The profile then categorizes the patient as at low, moderate, or high risk of opioid abuse. Another test would need to be purchased to determine the patient's predicted response to MAT.

Whether these tests can assist in treatment decisions or simply raise the cost of treatment remains to be seen. However, last November (2016), the Obama administration dropped plans to create a role for the FDA in providing oversight of LTDs. The debate on whether oversight is needed, and how it would proceed, will be left to the new Trump administration and Congress to conduct at a later, undetermined time.

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