Biomedical Engineering Reference
In-Depth Information
cancer assay is also an RT-PCR-based molecular diagnostic test
that quantitatively measures 12-gene expression and assess the
recurrence risk in stage II colon cancer.
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It includes five reference
genes and seven cancer-related genes that are associated with the
activated stroma, cell cycle and early response or genotoxic stress
pathway. The assay generates a RS for individual patients from
the reference gene normalized tumor expression of the 7-cancer
related genes. It predicts the recurrence risk in patients with stage
II colorectal cancer after surgery. However, it did not significantly
predict benefit of 5-fluorouracil/leucovorin chemotherapy.
1.7
Diagnostic Techniques for Therapeutic
Biomarkers
Details of diagnostic techniques used for detecting an individual
therapeutic biomarker are discussed in relevant chapters. Table
1.4 presents a summary of the clinical diagnostic tests that include
technical methods, brief detection mechanisms, and their therapeutic
biomarker applications.
1.8
Conclusions and Perspectives
The steady advance in the development of targeted cancer therapy
continues to assure the increased success and reduced toxicity in the
management of cancer patients. Besides the therapeutic biomarkers
already in the clinic, most of the promising biomarkers discussed in
this topic are very likely to evolve as valid therapeutic biomarkers
in the next few years. The US National Institutes of Health and
the FDA provide the scientific and regulatory framework for the
co-development of drug-biomarkers.
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In particular, the AACR
(American Association of Cancer Research)-FDA-NCI (National
Cancer Institute) Cancer Biomarker collaborative is bringing all
national efforts together by integrating pharmacodynamic and
diagnostic biomarkers into the cancer drug development enterprise.
5
We anticipate that more targeted cancer therapeutics and their
companion therapeutic biomarkers will be developed and validated
by the academic, government and private sectors in the years to
