Article preview from Start-Up February 24, 2009
Traditional diagnostic tests for Her2 (the target of the drug Herceptin) have well-documented failings. In July, Monogram Biosciences launched a new Her2 test, and two months later, Genomic Health added Her2 status information to its breast cancer test. Read on...
Article preview from Start-Up February 24, 2009
Traditional diagnostic tests for Her2 (the target of the drug Herceptin) have well-documented failings. In July, Monogram Biosciences launched a new Her2 test, and two months later, Genomic Health added Her2 status information to its breast cancer test.
In July 2008, Monogram Biosciences Inc. launched HERmark, the first commercially available functional Her2 assay, which measures total Her2 proteins and Her2 heterodimers. Two months later, Genomic Health Inc. added a readout of Her2 status to its reverse transcription PCR (RT PCR)-based Oncotype DX breast cancer test panel, which measures mRNA expression. Unlike the traditional Her2 breast cancer assays, which are based on immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) techniques that measure overexpression of Her2, neither test has US Food and Drug Administration approval. Nor are they included as companion diagnostics on the labels of the Her2-targeting drugs for treating breast cancer: Genentech Inc.'s monoclonal antibody trastuzumab (Herceptin), and GlaxoSmithKline PLC's small-molecule lapatinib (Tykerb).
The new tests are drawing attention anyway, because of two factors. First, there's a well-documented lack of concordance between traditional IHC and FISH tests and among the labs that conduct them. Second, questions about whether patients who are Her2 negative by those earlier tests may nonetheless benefit from Her2 drug therapy are percolating throughout the oncology community. Indeed, while Herceptin has been the poster child for targeted therapy and companion diagnostics for a decade following the drug's approval, there's much that is not yet understood about Her2 biology and the disregulated pathways that may be at work in Her2-positive breast cancer.
These developments support the approach taken by Genomic Health, Monogram, and others that more comprehensive, multianalyte tests may better guide therapy and show a pharmacoeconomic benefit, even at eight to 10 times the cost. More generally, they point to the need for a more nuanced approach to the management of cancer as a chronic disease and suggest a more nuanced view of personalized medicine and of the capabilities that will be needed for commercial success in this area of diagnostics.
Adding Value to Her2 Testing...
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