Article preview from "The Gray Sheet"- May 17, 2010
A particularly public preemptive stance by FDA's in vitro diagnostics oversight office halted Pathway Genomics' plans last week to start selling genetic screening test sample collection kits out of Walgreens stores, but the office's director stresses the move does not signal any changes to its enforcement policy for laboratory-developed tests.
Article preview from "The Gray Sheet"- May 17, 2010
A particularly public preemptive stance by FDA's in vitro diagnostics oversight office halted Pathway Genomics' plans last week to start selling genetic screening test sample collection kits out of Walgreens stores, but the office's director stresses the move does not signal any changes to its enforcement policy for laboratory-developed tests.
Walgreens disclosed May 12 that it will postpone plans to offer Pathway Genomics' Insight saliva collection kits at nearly 7,500 of its stores. The move came just one day after Pathway announced its intention to offer the kits at the national retail outlets beginning this month.
Walgreens' decision came after FDA sent Pathway an, dated May 10, questioning the approval status of the tests and after Alberto Gutierrez, director of FDA's Office of In-Vitro Diagnostic Device Evaluation and Safety, provided explicit statements to national media outlets that Pathway was flouting FDA regulations.
The kits contain a vial that consumers can use to store their saliva, instructions for doing so, and a postage-paid envelope for mailing the vial to Pathway's San Diego laboratory.
After purchasing the kits, which are intended to retail at $20 to $30, consumers would be able to order variously priced screening services via the company's website to identify risk markers for developing certain diseases ($179) or passing diseases to offspring ($179), or for predicting response to certain medications ($79), according to Pathway. All three reports could be ordered for $249.
The firm, which already sells similar sampling kits and services to consumers over the Internet, says it does not need FDA go-ahead because the offerings qualify as traditionally non-agency-regulated laboratory-developed test services and the company is not making diagnostic claims that require FDA oversight.
But FDA's Gutierrez disagrees. And he says there is no need for the agency to buck precedent on lab-developed test oversight to go after Pathway, or, likely, other companies that sell similar genetic screening services over the Internet, including 23andMe and Navigenics.
- David Filmore
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