By now, the term “Personalized Medicine” has become a buzzword in the healthcare industry and rightfully so. This new approach is exploring new preventive measures, diagnostic methods and treatment frontiers. Just a few weeks ago, there was news about Jimmy Carter’s melanoma cancer remission,1 which is directly tied to personalized drug treatment based on pharmacogenomics. Personalized medicine is offering hope to millions of patients who previously had to rely on a “one-size-fits-all” approach to therapy for a number of different conditions.
Behind the advent of personalized medicine, there is a body of research that has uncovered critical information about individual genetic variability, specific biomarkers necessary for pathogenicity, patient pharmacogenomics and overall disease process at the molecular level. Translational research is responsible for bridging the gap between basic research and the market, transforming scientific knowledge into clinical solutions.
For example, before Herceptin was approved by the FDA in 1998,2 scientists had to demonstrate its effectiveness as a monoclonal antibody against the cell-surface receptor HER2 (human epidermal growth factor receptor-2). Herceptin is used as an immune targeted therapy to help suppress the rapid growth of breast cancer cells. This discovery is the result of years of experimentation and scientific investigation. Another example is the discovery of Epidermal Growth Factor Receptor (EGFR) and the subsequent FDA approval of Erbitux (cetuximab) as an EGFR inhibiting targeted therapy. EGFR is often over-expressed in certain carcinoma types and is involved in the over-proliferation of cancer cells.3
It is important to note that scientific research investigation would not be possible without biospecimens for researchers to experiment on. What this means is that researchers need biospecimens to continue testing new theories, which can ultimately lead to deeper understanding about disease processes and improved diagnostic and treatment choices.
In order for scientists to perform research investigations, biospecimens have to meet certain criteria to match the specific research study. For example, a study looking to detect specific biomarkers for colorectal cancer patients will require plasma and or tissue samples from colorectal cancer patients. Researchers can design studies with very broad or very specific requirements depending on what is being studied. It becomes extremely challenging and time-consuming to find biospecimens that match the specific requirements necessary for the clinical trial or study.
Biorepositories answer this need by acting as a specimen warehouse where patient samples and associated clinical data are stored and categorized by disease type and stage. Biorepositories and Laboratories have a lot in common, and, at the same time, are also very different. One can find similarities in the pre-analytic and post-analytic phases of testing. There is no analytic phase associated with biorepositories; tasks are limited to essentially sample collection, handling or processing, storage and shipping-unless the biorepository also offers Laboratory services.
What makes Biorepositories unique compared to Laboratories?
Specimen collection occurs under the umbrella of an Institutional Research Boards (IRB)-approved protocol and requires informed consent procedures. IRB (also known as independent ethics committees) is made up of independent agencies approved to oversee research projects involving human subjects. IRB approval defines the scope of specimen collection and handling. Informed consent procedures are mandated by law, proper documentation of consent is required prior to specimen collection.
Similar to Laboratories, equipment and temperature monitoring are essential components of a biorepository’s quality program. This type of monitoring helps maintain the quality of specimens in the long-term. A comprehensive quality management system will specify and monitor specimen storage requirements per specimen type (-80F, liquid nitrogen freezing, room temperature storage, etc.) as well as point out inconsistencies.