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CvergenX, NCI Partner on Radiation Therapy Prediction Assay

NEW YORK (GenomeWeb News) – With the help of the National Cancer Institute, CvergenX is developing a radiosensitivity test for use in determining how patients respond to radiation therapy, the company said late Tuesday.

NCI has chosen CvergenX's technology called InterveneXRT for further development and validation in a commercial collaboration in order to advance the assay for use in clinical trials and potentially approval by the US Food and Drug Administration. CvergenX is developing the technology in conjunction with NCI's Clinical Assay Development Program.

A collaboration between CvergenX and Moffitt Cancer Center resulted in preliminary data on the effectiveness of a molecular signature in trials for patients with rectal, esophageal, head and neck cancers, as well as patients with breast cancer. With more than $2 million in funding, primarily from NCI, the technology has been "developed and correlated with retrospective clinical outcomes over more than seven years of research," the Tampa, Fla.-based firm said.

The goal now is to develop InterveneXRT to the point where it can determine which patients will respond to radiation treatment and which ones won't.

The radiosensitivity molecular signature was developed based on gene expression for 10 specific genes and a linear regression algorithm. The firm added that it was developed in 48 cancer cell lines using a systems biology strategy focused on finding biomarkers for cellular radiosensitivity.

CvergenX said the effort initially is focused on rectal cancer. Radiation therapy is the standard of care for patients with stage 2 or 3 disease, but 40 percent of patients do not have a clinical response to pre-operative treatment.

The goal of the CADP is to show whether the assay can identify patients who won't benefit from pre-operative chemoradiation. NCI will provide the financing, expertise, and labor for the development of the assay, CvergenX said.

"Developing a radiosensitivity predictive assay has been a goal of radiation biology for decades," Javier Torres-Roca, co-founder and CSO of CvergenX, said in a statement. He also is a member of the Radiation Oncology, Chemical Biology and Molecular Medicine Programs at Moffitt. "This effort supports the emphasis on personalized medicine, where the goal is to use molecular signatures to guide therapeutic decisions."

CvergenX Chairman and CEO Mary Del Brady said that the plan is to launch a validated test with clinical utility within the next three years. "The test will provide more information and far greater accuracy than oncologists have ever had, enabling them to adjust their clinical management for better outcomes for their patients," she said.