Five Genetic Test Makers Told To Get FDA Approval Before Selling Products To The Public

Five Genetic Test Makers Told To Get FDA Approval Before Selling Products To The Public
Editor's Choice
Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Genetics; Medical Devices / Diagnostics
Article Date: 12 Jun 2010 - 0:00 PDT


Five makers of genetic tests have been told by the US FDA (Food and Drug Administration) that they have to obtain federal approval before selling and/or marketing their genetic tests to the general public. The regulatory letters went online today (Friday, 11th June, 2010) - an indication that the agency is planning to clamp down on firms selling products that are supposedly able to predict inheritable disease risk and possible responses to medications using samples of DNA.

The FDA says that these companies' products are medical devices, and as such have to be federally approved as effective and safe.

The online letters specifically refer to the following genetic test makers:
23andMe Inc.
deCODE Genetics
Illumina
Navigenics
Knome Inc.

deCode Genetics, 22andMe Inc., and Illumina make tests that screen people for their risk of developing health conditions, or their response to some medications. According to the FDA, none of these three companies has submitted its product for approval.

Knome Inc. and Navigenics are makers of high-grade testing and software that companies utilize to analyze DNA. According to FDA regulations, they should be reviewed as medical devices.

The FDA is asking these companies to make arrangements for the submission of their products for approval.

Saliva-base test kits have been sold online for several years, the FDA informs, with minimal supervision.

According to Reuter's news agency, 23andMe does not believe its product requires federal approval. The company said it understands FDA concerns, but believes people have the right to know about their own genes and bodies.

Ever since Pathway Genomics announced that its genetic tests would be sold in Walgreen outlets throughout the USA (Link to article), the FDA has become interested in genetic test kits that are being sold to consumers.

Source: FDA, Reuters
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Five Genetic Test Makers Told To Get FDA Approval Before Selling Products To The Public