Medical Device Daily

Colon cancer causes about 655,000 deaths worldwide each year, and is the fourth most common form of cancer in the U.S. and the third leading cause of cancer-related death in the western world.

Physicians currently use a method called clinical staging to measure the extent of disease spread at the time of diagnosis. Patients who are diagnosed with early-stage tumors (1-2) generally do not receive chemotherapy; however, about 20% of stage 2 patients develop recurrence within five years.

ChipDX (New York) reported that it is developing an online screening application to enable clinicians to more accurately identify the risk of recurrence of colon cancer in patients.

The small start-up firm is making the algorithm available for research use only through an online gene expression analysis platform at www.ChipDX.com and said that it is reviewing regulatory requirements and partners to market it as a test for future diagnostic use.

“Our website is functional but [the algorithm] hasn't been cleared by the FDA yet,“ Ryan van Laar, PhD, ChipDX founder and CSO, told Medical Device Daily. “So it isn't to be used on patients at this point. But once approved the plan is to have this available so that clinicians can upload results to our website.“

So far the company has teamed up with Affymetrix (Santa Clara, California) in the endeavor.

To obtain results from the site, clinicians would first take tissue samples from the tumor and plug it into Affymetrix's Genechip technology. The Genechip would then come up with numerical data that can be uploaded to the site.

In a recent study, published in the December issue of the British Journal of Cancer, ChipDX demonstrated how the 163-gene signature stratifies colon cancer patients into high- and low-risk groups for recurrence with greater accuracy than current methods.

“We discovered a set of genes that were strongly associated with outcome, independent to current measurements of prognosis. By combining measurements of these genes, performed with Affymetrix GeneChip technology, and a robust predictive algorithm we were able to predict which individuals were at the greatest risk of recurrence within a five-year follow-up period,“ van Laar said. “This unique signature's ability to generate a highly personalized assessment of recurrence risk may one day assist physicians in deciding whether individuals with early-stage colon cancer should receive chemotherapy in addition to surgery.“

The company said that it developed its prognostic algorithm by analyzing data from a 2009 study of 232 U.S.-based colon cancer patients. An independent validation series of 60 stage 2 and 3 Australian colon cancer patients was used to validate the discovery. Both studies used Affymetrix GeneChip Human Genome U133 Plus 2.0 Array profiles of colon cancer patients. The method of gene expression data analysis performed was designed to identify genes significantly associated with recurrence independent of the patient's age at diagnosis, tumor grade, or disease stage.

An important component of the platform is the proprietary ChipDX Quality Module, developed by analyzing more than 3,000 GeneChip profiles of multiple tumor types generated in laboratories around the world.

“Ultimately, we hope our predictive gene signature will help doctors to identify these early-stage 'high-risk' patients and offer them more personalized treatment options based on a set of genes related to survival above and beyond traditional assessments of outcome,“ said van Laar. “If treatment is tailored to the precise nature of a patient's tumor, the life-saving potential is greater.“

This module ensures that each assay meets a high level of data integrity before a diagnostic analysis is performed. After this analysis, the data can be submitted to the newly created Colon Cancer Module, which uses the recently published 163-gene predictive algorithm to generate an individualized assessment of recurrence risk, in real-time.

“A lot of doctors want to use this,“ he said. “Other tests out there have clinicians sending in a sample to another state, so that can be a bit burdensome. This is test is easier logistically than others. All the clinician has to do is upload the data to our website.“

In the future, van Laar told MDD that the firm has been working on applications for breast cancer and lung cancer.

Omar Ford, 404-262-5546;
omar.ford@ahcmedia.com