Cancer proteomics: developments in technology, clinical use and commercialization

Abstract

In the last two decades, advances in genomic, transcriptomic and proteomic methods have enabled us to identify and classify cancers by their molecular profiles. Many anticipate that a molecular taxonomy of cancer will not only lead to more effective subtyping of cancers but also earlier diagnoses, more informative prognoses and more targeted treatments. This article reviews recent technological developments in the field of proteomics, recent discoveries in proteomic cancer biomarker research and trends in clinical use. Readers are also informed of examples of successful commercialization, and the future of proteomics in cancer diagnostics.

Keywords:

• cancer
• commercialization
• companion diagnostics
• mass spectrometry
• molecular diagnostics
• predictive biomarkers
• prognostic biomarkers
• protein biomarkers
• proteomics
• regulation
• screening biomarkers

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.

Key issues

• Protein microarrays are constrained by the expense and difficulty of designing and validating antibodies specific to target proteins.

• Mass spectrometry has yet to replace older low-throughput technologies such as immunohistochemistry in the clinic because the sensitivity of mass spectrometry still lags the best ELISA methodologies by two to three orders of magnitude.

• Serum-based biomarkers that are sensitive and specific enough to be used as screening tests remain elusive.

• Single protein biomarker assays are unlikely to perform adequately for most diagnostic and screening applications, so efforts are being directed toward constructing panels of biomarkers.

• In the coming years, companion diagnostics will be a main driver of growth in cancer biomarker commercialization.

• The possibility of increased regulatory oversight of molecular diagnostic testing heralds both challenges and opportunities for the proteomics community.