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The power of prediction
TAMPA, Fla.—CvergenX Inc., a Moffitt Cancer Center diagnostics startup company, and the National Cancer Institute (NCI) are collaborating on developing a new test to determine which cancer patients will benefit from radiation therapy—and which will not. If successful, this joint endeavor would result in an accurate test that ultimately not only saves money on unnecessary procedures, but also saves lives.
To pave the way, CvergenX signed a partnership deal with the NCI's Clinical Assay Development Program (CADP) to harness a molecular signature index technology called InterveneXRT, the company announced April 8. CvergenX created the gene-based diagnostic technology, which Moffitt owns and licensed to CvergenX, in June 2010.
"Developing a radiosensitive predictive assay has been a goal of radiation biology for decades," Dr. Javier F. Torres-Roca, a member of the Chemical Biology and Molecular Medicine Program at Moffitt, and co-founder and chief scientific officer of CvergenX, stated in a news release. "This effort supports the emphasis on personalized medicine, where the goal is to use molecular signatures to guide therapeutic decisions."
Approximately 60 percent of all cancer patients receive radiotherapy during their treatment, but until now, no molecular diagnostic or biomarker for radiosensitivity has been developed to predict its benefit, Torres-Roca says. Through a series of clinical trials, Torres-Roca has validated the molecular signature efficacy of InterveneXRT for patients with rectal, esophageal, head and neck and breast cancers. The NCI partnership will help develop an assay that is ready for approval by the U.S. Food and Drug Administration (FDA) for commercialization.
"CvergenX is one step closer to launching a game-changing prediction test for radiation therapy as a result of their exciting partnership with the NCI," says Jarett Rieger, director of the Office of Technology Management and Commercialization.
The radiosensitive molecular signature was originally developed based on gene expression for 10 specific genes and a linear regression algorithm. It was developed in 48 cancer cell lines using a systems biology strategy focused on identifying biomarkers for cellular radiosensitivity. The initial effort focused on rectal cancer, where preoperative radiotherapy is part of the standard of care for patients in stage 2 or 3 of the disease. However, approximately 40 percent of patients do not experience a clinical response to preoperative treatment. To date, the technology has been developed and correlated with retrospective clinical outcomes over more than seven years of research and with the help of more than $2 million in funding, primarily from the NCI.
Mary Del Brady, CvergenX's chairman and CEO, says the individualization of radiation therapy is an important component of personalized cancer treatment.
"We are the first commercial enterprise to develop a companion diagnostic to radiation therapy, joining a growing group of personalized medicine companies that are applying genomics-based analysis to clinical practice," Brady says. "Our goal is to have a validated test with proven clinical utility in the marketplace within the next three years. The test will provide more information, and far greater accuracy than oncologists ever had, enabling them to adjust their clinical management for better outcomes for their patients."
Radiation therapy "has been shown to impact survival in multiple cancers including breast, lung, prostate, head and neck and others," she notes. "Therefore, it is possible that the more efficient utilization of radiation therapy that will result from the clinical application of this test could result in improved clinical outcomes at the survival level."
There are 1.5 million newly diagnosed cancer patients in the United States every year, "with more than 60 percent receiving radiation therapy," Brady says.
"Worldwide, the market is huge, with more than 1.38 million cases of breast cancer alone. While we do not assume that every patient will require the test, there is certainly a very large market both domestically and internationally across most cancers," she concludes.