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Theranostics
Theranostics entail the utilization of a diagnostic to classify disease subtype or stage (and/or patient type), in order to select and qualify a specific course of treatment, and to monitor patient response to the selected therapy. The market for theranostics is still in its infancy, but is expected to grow rapidly due to the recent FDA mandate:
“If evidence is available to support the safety and effectiveness of the drug only in selected subgroups of the larger population with the disease, the labeling shall describe the evidence and identify specific tests needed for selection and monitoring of patients who need the drug.”1
Herceptin™ (Genentech) is one of the most recognized examples of this new theranostic strategy. Herceptin™ targets the her2/neu receptor, which is a biomarker for an aggressive subset (25%) of diagnosed breast cancers. HER2/neu can be detected by molecular diagnostics from biopsy samples of breast tumor tissue. Herceptin™ would not be given to the general population of breast cancer patients, because it does not have a beneficial impact on patient tumors that do not express the her2/neu receptor. However, in the her2/neu-expressing breast cancer subpopulation, treatment with Herceptin™ cuts the 4-year recurrence rate in half (from 33% to 15%)2 and thus extends the life of many breast cancer patients.
TDI works with drug discovery and development partners to develop theranostic assays to support their therapy, in cases where protein isoforms are known or suspected to be useful biomarkers. These collaborations are typically formatted with the pharmaceutical partner assuming the project costs for assay development and validation, and structured for TDI to retain commercialization rights to the theranostic assays.
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1 21 CFR 201.57
2 Roche press release (May 16, 2005)
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