Genomic Health plans to provide FDA with comments on new draft guidance

By Jennifer Lanning Drey

Eugene, Ore., Sept. 6 - Genomic Health, Inc. will work with the Food and Drug Administration to provide feedback on the agency's newly released draft guidance regarding the regulation of certain laboratory developed tests, according to Randy Scott, president and chief executive officer of Genomic.

The company hopes to participate in shaping future regulatory policies by providing comment on the draft, Scott said Wednesday during the Thomas Weisel health care conference.

"We certainly are encouraged that this has now become an open process," Scott said.

The FDA's draft guidance was released Tuesday and focuses on "In Vitro Diagnostic Multivariate Index Assays." The draft does not yet establish any legally enforceable responsibilities.

The guidance will help Genomic gain clarity on what types of tests that may be regulated in the future, Scott said.

He also encouraged investors to read and comment on the FDA's draft guidance.

Genomic's test service, Oncotype DX, is used to predict the likelihood of breast cancer recurrence and chemotherapy benefit in early stage patients. It has been commercially available since 2004.

Genomics has been in ongoing discussions with the FDA since January regarding possible future industry regulations the agency may chose to impose.

Genomic Health is a Redwood City, Calif., life sciences company.

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