Creating a Genetic Testing Specialty Under CLIA

Since the inception of the Human Genome Project in 1990, genetic testing has become an increasingly integral component in the diagnosis, treatment, management, and prevention of numerous diseases and conditions Today, the number of genetic tests available is rising dramatically, with new tests entering the healthcare market every day Information gained from genetic test results has a significant impact on medical decision-making Incorrect genetic test results can lead to misdiagnosis, inappropriate and/or delayed treatment, anxiety, and, in rare cases, even death While there are many diligent laboratories that comply with voluntary measures to ensure quality, the absence of oversight creates an environment in which poor performers can continue in the marketplace and bad actors can go undetected and uncensored From the doctor and patient's perspective, moreover, the minimalist level of regulation makes it difficult to distinguish high quality from low quality laboratories As the role of genetic testing in medicine continues to grow, so too does the urgent need to ensure that the genetic tests offered to the public are accurate and reliable and provide information relevant to a patient's current or future health status.