FDA Authorizes 23andMe to Offer Pharmacogenetic Testing on Consumers

Direct access testing (DAT), also called direct to consumer (DTC) testing, is consumer-initiated testing via the web with consumer payment. Such testing has been available for many years. Here's my note about the topic from 2006:Four Categories of Direct Access Testing. The early DAT test menu covered mainly routine tests with the addition of more esoteric ones over time. Now comes news that the FDA is authorizing direct-to-consumer (DTC) pharmacogenetics tests (PGx) without a physician order by 23andMe (see:FDA Authorizes 23andMe to Report Results of Direct-to-Consumer Pharmacogenetics Test to Customers without a Prescription, Bypassing Doctors and Clinical Laboratories). Below is an excerpt from the article:...(T)he US Food and Drug Administration (FDA) has authorized a DTC test company to provide results of a pharmacogenetic (PGx) test to customers without needing a doctor ’s order. This is the first genetic test of its kind to receive such FDA authorization and is in line with the government ’s focus on precision medicine.23andMe gained the authorization through the FDA ’s de novo classification process, which the FDA uses to classify new devices that have no existing classification or comparabledevice on the market....Demand for PGx testing has increased exponentially as it becomes more valuable to consumers. It could provide a path to precision medicine treatment plans based on each patient ’s genetic traits. And help determine which drug therapies and dosag...
Source: Lab Soft News - Category: Laboratory Medicine Authors: Source Type: blogs