This story has been updated from a previous version to include additional comments from the company.
The National Institutes of Health recently awarded Falcon Genomics a $269,640 grant to help it develop a biochip-based test that will be used for both cancer target identification and diagnostics.
Entitled "Development of a Test Cancer Biochip for the Cancer Biochip System," the one-year grant started Sept. 1 and is scheduled to end on Aug. 31, 2011.
Pittsburgh-based Falcon Genomics has to date marketed its Cancer Biochip System for research purposes only. The firm hopes to use the new funds to move the platform into the clinical arena.
"Today, the CBCS is marketed as a screening tool," said President and Chief Scientific Officer Rula Abbud-Antaki. "Our NIH funding will allow us to take it a step further and develop the CBCS as a molecular diagnostic tool."
Abbud-Antaki told BioArray News this week that Falcon Genomics envisions that the Test Cancer Biochip in development will be used for the "functional genomic profiling of breast-cancer patients that will allow for the personalized formulation of therapies."
Abbud-Antaki co-founded Falcon Genomics with James Antaki and Victor Keyloun in 2004. The firm's CBCS platform uses a three-dimensional biochip to enable the "rapid, high-throughput, automated, and quantitative identification and validation of inhibitors of cells," she said.
According to Abbud-Antaki, the CBCS supports high-throughput screening for inhibitors of anchorage-independent cancer cell growth through a one-step silencing RNA or short-hairpin RNA transfection approach with live monitoring and quantification of colony growth.
Falcon Genomics currently sells a human tumor stem-cell assay for use on the CBCS that is meant to test for chemosensitivity in patient tumor cells. While the firm markets the assay to researchers, Falcon Genomics concedes that it currently "suffers from many pitfalls" that make it unfit for high-throughput clinical testing.
"The gold-standard of in vitro testing for potential chemotherapeutic agents is the anchorage-independent growth assay, since it tests growth of transformed tumor cells in a three-dimensional matrix," Abbud-Antaki said.
While these cells are capable of recapitulating the tumor phenotype in vivo on the CBCS, she said that, in its current format, this assay is not amenable for large-scale screening or personalized diagnostics, an issue that is guiding its current development work.
"By miniaturizing the assay conditions, we have eliminated the need for large quantities of tumor cells and reagents, thereby making it amenable for high-throughput screening," Abbud-Antaki said.
The upgraded assay on which the company is now working should be suitable for clinical use, with a focus on breast cancer. According to the new grant's abstract, this assay will rely on siRNAs to "inhibit the expression of abnormally expressed tumor genes," and to "test their impact on anchorage-independent tumor growth in a high-throughput fashion."
Falcon Genomics envisions the planned Test Cancer BioChip as a tool for "optimizing plating, transfection, silencing, and cytostatic efficiencies," the company stated in the abstract. "Through future clinical trials, we anticipate development of the CBCS into a cancer diagnostic and personalized therapeutic tool," the firm states.
Abbud-Antaki said that a wide array of molecules could be tested with the CBCS, but that the firm has focused on siRNA for the development of a functional genomic test. "We first identify abnormally expressed genes and then suppress those genes with siRNA to identify which ones are responsible for tumor cell growth," she said.
According to Abbud-Antaki, one advantage of this approach is that it provides information about the function of abnormally expressed genes. "Although many genes are expressed abnormally in cancer cells, only a few are involved in the initiation and maintenance of the abnormal cell growth associated with cancer," she said. Using the CBCS, "individualized silencing of tumor genes provides a more refined level of tumor classification and information about potential siRNA and non-siRNA-based therapeutics."
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Falcon Genomics is not alone in its interest in breast cancer. Both Genomic Health and Agendia have assays on the market that guide the treatment of the disease. Still, Abbud-Antaki maintains that her company's planned test is different.
"Agendia's MammaPrint and Genomic Health's Oncotype Dx are assays that examine gene expression and provide prognostic information for a certain subtype of breast cancer patients," she said. "Patients identified to have poor prognosis with the MammaPrint or high recurrence score with the Oncotype Dx assays have no recourse."
Falcon Genomics' assay instead will identify "which ones of the multitudes of abnormally expressed tumor genes are responsible for tumor growth," Abbud-Antaki said. "By providing a functional genomic profile for each breast cancer patient, we can then formulate personalized and targeted therapies."
Ultimately, Falcon Genomics believes that its CBCS will assist in the diagnosis and development of cancer therapies for other indications, "since all types of cancers that are capable of growing in an anchorage-independent fashion can be tested on the Cancer BioChip System."