ColoPrint stratifies stage II and III patients as having low or high risk of their cancer returning.

Agendia has decided to launch ColoPrint, a prognostic test for colon cancer, next week. ColoPrint is a microarray-based 18-gene expression profile that can be used to determine the risk of stage II or III cancer returning in patients who have undergone surgery.

Oncologists are already familiar with Agendia’s suite of breast cancer tests. In February 2007, MammaPrint for breast cancer recurrence became the first multivariate in vitro diagnostic assay to receive FDA clearance. Now, doctors will be able to leverage ColoPrint to guide colon cancer patient care. “Doctors using the test will get a definitive answer: either high or low risk with no in between,” David Macdonald, Agendia CEO, told GEN.

This ease-of-use, which leaves less up for debate, is key for uptake, both from physicians’ point of view as well as from payors’. The company doubled its sales force between 2011 and 2012, and with the overlap in oncologists in the breast and colon cancer areas, Macdonald expects ColoPrint to be well received.

As with other cancers, the earlier the disease is detected, the more chance of survival there is. Colon cancer tends to recur within 3–5 years of treatment, with most colon cancers recurring within three years, Iris Simon, Ph.D., senior director of R&D, explained to GEN. Clinical guidelines currently recommend observation for stage I disease and adjuvant chemotherapy with a combination of a fluoropyrimidine and oxaliplatin for those with stage III disease.

While patients with stage III disease treated with adjuvant chemotherapy typically have a survival advantage, many are cured with just surgery. And adjuvant treatment in stage II patients is contentious. “We saw a clear clinical need in stage II colon cancer, and hence from the start we were focused on early-stage patients,” Dr. Simon added.

The decision to launch ColoPrint was a result of four retrospective studies including three validation studies, Erentia Gillmer, Agendia’s senior director of marketing, pointed out. ColoPrint clearly stratified patients into high- and low-risk groups and performed better than clinical factors detailed by American Society of Clinical Oncology (ASCO), National Comprehensive Cancer Network (NCCN), and European Society of Medical Oncology (ESMO), Gillmer told GEN. Agendia’s position, however, is that ColoPrint should be used to complement clinical factors for more personalized clinical management.

ColoPrint was developed using gene-expression data from whole-genome microarrays. In each of the studies done with ColoPrint, there were approximately 200 untreated patients. One of the three validation studies was a pooled analysis of 320 patients. The studies relied on fresh frozen tissue from five European hospitals. The reason that European patients and samples were used in the development and validation studies is because tumor banks in the U.S. weren’t set up as well as their European counterparts when ColoPrint development began in 2006, Dr. Simon explained.

The company does have plans to conduct a retrospective validation study at the University of Texas MD Anderson Cancer Center. Additionally a prospective study called PARSC is under way. It is enrolling patients in 34 centers: 17 in the U.S., two in Asia, and the rest in Europe. The last patient is expected to be enrolled by the end of this year and final data is expected by 2013, Dr. Simon noted. “We just looked at first results, and it looked very good.”

The drawback of using fresh frozen tissue is that studies cannot benefit from material collected from randomized clinical trials and thus sample sizes tend to be smaller. The results from PARSC will go a long way toward building confidence around ColoPrint.

Genomic Health’s Oncotype Dx colon cancer assay will be ColoPrint’s major competition. It uses formalin-fixed paraffin-embedded tissues, was reportedly tested in more than 1,800 patients from four trials, and was launched in January 2010 for use in patients newly diagnosed with stage II colon cancer. The 12-gene expression profile returns a score between 0 and 100 that correlates with the likelihood of a patient’s cancer returning.

This is where ColoPrint could have an advantage over Oncotype Dx. “What is unique about ColoPrint is that it separates the risk of disease recurrence or relapse into low and high risk groups,” Gillmer pointed out. “We do not have an intermediary group and therefore provide physicians with a 100% actionable result.” A patient in the low-risk group has a 1 in 13 chance that his/her cancer will relapse, while in the high-risk group, it is a 1 in 5 chance, Dr. Simon explained.

Signal Genetics also has a prognostic tool for colon cancer that stratifies patients in high- and low-risk groups, but the test is for research use only. The company acquired the test when it bought ChipDx in February. The diagnostic is based on a 163-gene signature.

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