One week before the NIH roadmap came out, the NCI began the process of renewing and expanding a series of four grants establishing an Early Detection Research Network for the discovery and validation of biomarkers for cancer detection and risk assessment. The original RFAs, issued in 1999, established four categories of institutions that make up the network: biomarker developmental laboratories, biomarker validation laboratories, clinical/epidemiologic centers, and data management and coordinating centers. At least five of the 18 labs that make up the biomarkers development contingent, including HUPO president Sam Hanash’s lab at the University of Michigan, are using mass spec technology and other proteomics techniques to look for protein biomarkers.
The first of the four new RFAs — all of which will be released in succession in the next few months, according to Mukesh Verma, one of the administrators of the grant — commits $7 million in FY 2004 to fund 16 to 18 five-year grants for biomarker developmental laboratories. All current members of the network will need to reapply for the grant, and the determining criteria will be different for new applicants so that current members will not have an unfair competitive advantage. “Investigators who have been in the RFA already, you can imagine that in that amount of time they are already at an advanced stage. So if we keep the same criteria, then the existing members will beat the new members,” Verma said.
The primary strength and purpose of establishing a network that links together scientists working on different stages of the biomarker problem, according to Verma and several member investigators, is the ability to pool resources and double-check results. “If anytime one institute reports a biomarker, either the same sample or a similar cancer sample should be analyzed by others, with different processes — there are different levels and different analyses,” Verma said. Verma gave the example of a prostate cancer biomarker candidate discovered using SELDI-based expression at Eastern Virginia Medical School. In order to validate that the marker was a reasonable candidate, samples were sent to five other institutes — some using Ciphergen’s SELDI system and some using an ABI Q-STAR — where scientists independently tried to reproduce the results. Only after reproducibility has been established will the biomarker move forward in the process. Three biomarkers have reached the analytical validation stage thus far as part of this network process, according to Verma, although none have yet reached the clinical stage.
Verma noted that it took time for investigators to get used to collaborating. “Before this network concept, everyone was independent, but here they not only have to come and report, but collaborate as well with samples and assays they are working on,” he said. Still, conversations with investigators revealed nothing but praise for the collaborative element. “This is something that NCI has tried to do with a lot of these multi-center studies, and this is one where it really is working well,” said Bruce Trock, a network member and principal investigator for a SELDI-based breast cancer biomarker study.
The application receipt date for RFA-CA-04-006, is Jan. 23, 2004.
— KAM