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New Releases: Mar 30, 2011

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Everist Genomics this week announced the worldwide commercial availability of its OncoDefender-CRC colorectal cancer assay.

The prognostic test predicts the risk of recurrence of cancer for patients previously treated with surgical resection of a Stage I/II colon cancer tumor or Stage I rectal cancer tumor. The OncoDefender-CRC test gauges expression levels of multiple genes from formalin-fixed, paraffin-embedded cancer tissue taken from patients at the time of surgery.

The OncoDefender-CRC, based on Everist Genomics’ patented Evolver platform technology, applies "a proprietary computer-generated decision rule" to assess which patients are at high risk for cancer recurrence. Those deemed to be at high risk for recurrence are likely to benefit from adjuvant therapy or more aggressive treatment options, the company said.

According to Everist CEO Prasad Sunkara, the test addresses an unmet need for Stage I rectal cancer patients, for whom there are limited prognostic options. The company tells patients that it will help them figure out whether their insurance covers the test and will bill Medicare of the private insurer on patients' behalf.

If patients' insurance company doesn't cover the test, then Everist Genomics has pledged them financial assistance. "Qualifying patients are eligible to have up to 80 percent of the cost of the OncoDefender-CRC test covered through one of the Everist Genomic Financial Assistance programs," the company says on its website.

Clinical research studies involving OncoDefender-CRC have been conducted on 500 patients from international sites.

In an external validation study, Everist enrolled patients from four international sites, and showed that OncoDefender-CRC differentiated patients at high risk of cancer recurrence from those who are at low risk for recurrence following surgery. "For stages I/II colorectal cancer (n=115), OncoDefender-CRC correctly classified 32/46 cases of recurrence and 38/69 cases of non-recurrence (sensitivity 70 percent, specificity 55 percent)," the company reported.

The study showed that patients deemed to be at high risk had a "significantly higher" probability of recurrence within 36 months than those the test found to be at low risk. "In contrast, the standard prognostic guidelines described by the National Comprehensive Cancer Network's clinical practice guidelines in Oncology were unable to differentiate recurrence risk in this population (p=0.315)," the company reported.

Everist claims that the sensitivity of OncoDefender-CRC exceeds that of other prognostic tests for early-stage CRC. OncoDefender-CRC does not report indeterminate or "no-call" results.

Everist's test is not alone in the colon cancer prognostic space.

Genomic Health last year launched its Oncotype DX colon cancer test, a multigene expression test to assess the risk of recurrence in patients with stage II disease after surgery. The 12-gene test yields a recurrence score between 0 and 100, which correlates to the likelihood that a person's cancer will return. The score can also be used by doctors to decide whether a patient needs to be treated with chemotherapy.

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