Skip to main content
Premium Trial:

Request an Annual Quote

FDA Sends DNA4Life Untitled Letter Regarding Pharmacogenetic Report Product

NEW YORK (GenomeWeb) – The US Food and Drug Administration has issued an untitled letter to direct-to-consumer genetic testing firm DNA4Life requesting additional information on the company's recently launched Pharmacogenetic Report product.

DNA4Life's product, the FDA asserted in its letter issued last week, is marketed directly to patients as a means to predict how they will respond to more than 120 of the most commonly prescribed medications. As such, the test appears to meet the definition of a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act.

The FDA further stated that it has been unable to identify an FDA clearance number for Pharmacogenetic Report and requested that DNA4Life either provide the agency with this number or with the reasons it believes that FDA clearance is not required for its product.

Mandeville, Florida-based DNA4Life introduced Pharmacogenetic Report last month. The company said that the test assesses the 12 most common genes affecting drug metabolism and response in a patient. This information is then compared with more than 120 of the most commonly prescribed medications across all major therapeutic classes.

Ordering of the test is "physician-integrated," as patients are required to share their results with physicians, the company said. The assay costs approximately $249, the company added.

The Scan

Interfering With Invasive Mussels

The Chicago Tribune reports that researchers are studying whether RNA interference- or CRISPR-based approaches can combat invasive freshwater mussels.

Participation Analysis

A new study finds that women tend to participate less at scientific meetings but that some changes can lead to increased involvement, the Guardian reports.

Right Whales' Decline

A research study plans to use genetic analysis to gain insight into population decline among North American right whales, according to CBC.

Science Papers Tie Rare Mutations to Short Stature, Immunodeficiency; Present Single-Cell Transcriptomics Map

In Science this week: pair of mutations in one gene uncovered in brothers with short stature and immunodeficiency, and more.