"Innovative approaches for tumor biopsy that preserve the molecular profile will create an entirely new diagnostic market in molecular therapeutics, which will not only facilitate pharmacodynamic assessment of targeted therapeutics but also enable individualized molecular therapy of solid tumors based on accurate information about... molecular drug targets and biomarkers."
NCI SBIR Announcement to Preserve Molecular Profiles in Tumors, 8/2007
"The lack of standardization of human biospecimens compromises the quality and the utility of molecular research and the advances in clinical medicine dependent on them. The reliability of molecular data derived from... new analysis platforms is dependent on the quality of biospecimens being analyzed."
Presentation at JHMI by Carolyn Compton, MD, PhD, Director, National Cancer Institute's Office of Biorepositories and Biospecimens. April 2007
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BioMarker Strategies, a tissue-based cancer diagnostics company, is developing an innovative tumor cell processing and sample preparation system to reduce pre-analytical specimen variability and maximize the diagnostic potential of human solid tumor cells. Our tumor cell processing and testing system is being designed to enable personalized medicine for cancer patients by:
- maintaining the biological integrity of tumor cells, including DNA, RNA, and proteins, for downstream molecular analysis
- allowing pathologists to better subcategorize cancer types
- improving the effectiveness of existing molecular diagnostic tests and facilitating the development of new molecular diagnostic tests
- helping drug companies to stratify patients and improve clinical trials to gain FDA approvals for new targeted cancer therapeutics
- helping oncologists determine which cancer drug therapy or combination of therapies to prescribe to an individual patient, and
- helping insurers to determine eligibility for coverage and drug reimbursement for targeted drug therapies.
The field of pathology, which focuses on the diagnosis of cancer, is undergoing dramatic change as the full implications of genomics and molecular diagnostics are beginning to be understood. Throughout the 20th Century pathologists relied almost entirely on microscopic interpretation of formaldehyde- fixed tumor cells to make a cancer diagnosis. In the 21st Century, genomic knowledge and molecular diagnostic technology promise to revolutionize the diagnosis of cancer and the management of cancer patients with novel targeted therapeutic drugs.
Unfortunately, the molecular analysis of solid tumors has been seriously impeded by antiquated tumor sampling and preservation systems, resulting from formalin-fixed paraffin-embedded (FFPE) tissue samples that are standard practice in pathology. These 19th century tumor sampling and preservation systems are inadequate for 21st century molecular diagnostics. While DNA analysis of FFPE tumor samples is possible, it is very ineffective, inefficient and expensive, and RNA and protein analysis of these tumors is even more problematic.
Analysis of fixed tumor samples present almost insurmountable problems of pre-analytical variability, thus creating a classic “garbage in, garbage out” scenario for molecular diagnostics. Poorly procured and maintained tissue samples, which introduce variation into the scientific process, are the enemy of scientific data reproducibility. As noted here, a cancer biomarker is only as good as its implementation, including pre-analytical processing of tumor samples, and the analytical and clinical validation of the test, also known as an assay, used to detect it.
BioMarker Strategies is currently developing the proprietary SnapPath (TM) tumor cell processing and sample processing system to address these concerns.
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