NCI caHUB and the Critical Path Institute [501(c)3] establish a collaborative agreement to perform biospecimen research

In October 2011, the NCI caHUB program and the Critical Path Institute [501(c)3] embarked on a new collaboration to accelerate the validation of diagnostic tools for patients with lung cancer. The collaboration will include the collection and delivery of specimens from donors under the robust quality control of caHUB to systematically assess the strength of various clinical diagnostic assays for patients with non-small cell lung adenocarcinoma. The intended outcome of this collaboration will be the development of guidelines that might expedite regulatory review and advance biospecimen science, broadly.

An emerging practice of medicine that holds great promise for the treatment of cancer patients involves the use of clinical diagnostic tests meant to help doctors identify the molecular basis of a patient’s specific cancer. One significant challenge in scientifically validating the performance of these diagnostic tests is that of using appropriate human specimens. Put simply, too many parameters are unknown or insufficiently controlled for, regarding the specimens used that either confounds the research during the validation process or brings into question the scientific data used to validate the diagnostic test. For this collaboration, the NCI’s caHUB team will collect surgically removed tumor biospecimens from consenting donors at select clinical centers around the United States to support this research under a comprehensive quality control system that ensures that the specimens used are fit for purpose. The Critical Path Institute, in collaboration with their industrial research partners, will use these biospecimens to rigorously assess a number of diagnostic tests that target known markers for non-small cell lung adenocarcinoma. The goal of this collaboration is to not only provide new tests for lung cancer patients, but more broadly to develop guidelines, standard protocols and hopefully a model for validating diagnostic tests.