Taking Markers from Discovery to Routine

HomeResearch TopicsTranslational ProteomicsTaking Markers from Discovery to Routine
Taking Markers from Discovery to Routine 2016-11-10T20:38:52+00:00

Notable peer-reviewed articles–biomarker verification and validation conforming to regulatory and QC requirements for routine tests.

 

Articles of note

Overview of the relationship between publications and patenting of biomarkers.

Pitfalls and limitations in translation from biomarker discovery to clinical utility in predictive and personalised medicine (free full-text)

Since the emergence of the so-called omics technology, thousands of putative biomarkers have been identified and published, which have dramatically increased the opportunities for developing more effective therapeutics. These opportunities can have profound benefits for patients and for the economics of healthcare. However, the transfer of biomarkers from discovery to clinical practice is still a process filled with lots of pitfalls and limitations, mostly limited by structural and scientific factors. Read more ›

Biomarker assay translation from discovery to clinical studies in cancer drug development: quantification of emerging protein biomarkers

Many candidate biomarkers emerging from genomics and proteomics research have the potential to serve as predictive indexes for guiding the development of safer and more efficacious drugs. Research and development of biomarker discovery, selection, and clinical qualification, however, is still a relatively new field for the pharmaceutical industry. Advances in technology provide a plethora of analytical tools to discover and analyze mechanism-and-disease-specific biomarkers for drug development. Read more ›

Biomarkers in translational research: focus on discovery, development and translation of protein biomarkers to clinical immunoassays

The field of biomarker discovery has exhibited a great surge of interest in recent years. Biomarkers can be used for many purposes including diagnosis, prognosis and selecting appropriate patient therapy, and can provide information on disease mechanism or progression. Translation of such markers to clinical testing encompasses phases for their discovery and characterization, assay development, and finally, implementation using automated platforms employed in clinical laboratories. Read more ›

The long journey of cancer biomarkers from the bench to the clinic (free full-text)

BACKGROUND: Protein cancer biomarkers serve multiple clinical purposes, both early and late, during disease progression. The search for new and better biomarkers has become an integral component of contemporary cancer research. However, the number of new biomarkers cleared by the US Food and Drug Administration has declined substantially over the last 10 years, raising concerns regarding the efficiency of the biomarker-development pipeline. Read more ›

From bench to bedside: discovery of ovarian cancer biomarkers using high-throughput technologies in the past decade

Ovarian cancer is the most lethal gynecological malignancy and survival of this disease has remained relatively unchanged over the past 30 years. A contributing factor to this has been the lack of reliable biomarkers for the clinical management of ovarian cancer. Rapid advances in high-throughput technologies over the past decade has allowed for new and exciting opportunities for biomarker discovery in the field of ovarian cancer, especially with respect to serum biomarkers that can be used for various clinical applications. Read more ›

Translation of proteomic biomarkers into FDA approved cancer diagnostics: issues and challenges (free full-text)

Tremendous efforts have been made over the past few decades to discover novel cancer biomarkers for use in clinical practice. However, a striking discrepancy exists between the effort directed toward biomarker discovery and the number of markers that make it into clinical practice. One of the confounding issues in translating a novel discovery into clinical practice is that quite often the scientists working on biomarker discovery have limited knowledge of the analytical, diagnostic, and regulatory requirements for a clinical assay. Read more ›

Translational research: current status, challenges and future strategies

Advances in translational research are expected to mitigate the recent drought in new drug development. Despite significant progress recently made in biological sciences, the results are decidedly mixed with significant breakthrough in some disease areas while extensive work remains to be completed in other areas. This review article provides a general survey of the current landscape of translational research so as to identify progress and areas of needs and the associated strategy. Read more ›

Translational research in the development of bortezomib: a core model (free full-text)

The high price of many innovative drugs, which is in part due to the costs, time and risks involved in drug development, calls for more efficient approaches to bring drugs to the market. Translational research (the bi-directional transfer of basic and pre-clinical findings to humans) has been identified as an important component of such strategies. While significant advances in the development of translational tools have been made in all fronts, the availability of predictive preclinical models remains critical for the success of translational research. Read more ›

The road from discovery to clinical diagnostics: lessons learned from the first FDA-cleared in vitro diagnostic multivariate index assay of proteomic biomarkers (free full-text)

BACKGROUND: After more than a decade of biomarker discovery research using advanced genomic and proteomic technologies, very few biomarkers have been translated into clinical diagnostics for patient care. This has become an urgent issue to be addressed because the continuing funding from both the public and private sources are called into question. Read more ›