RBC rates Genomic Health at sector perform

Genomic Health, Inc. was rated at sector perform, speculative risk, and $15 price target by RBC Capital Markets analyst William R. Quirk following the Food and Drug Administration's release of draft guidance on In Vitro Diagnostic Multivariate Index Assays (IVDMIA). Genomic Health's Oncotype Dx falls into the IVDMIA category and there is an increased probability that this currently unregulated assay will require premarket approval, according to the analyst. A worst case scenario would involve the removal of Oncotype Dx from the domestic market until 2008, allowing time for a full clinical trial. The good news is that Aetna issued a favorable reimbursement decision for Oncotype Dx. Shares of the Redwood City, Calif.-based biotechnology company were down $2.43, or 17.38%, at $11.55. (Nasdaq: GHDX)

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