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AHRQ: no evidence of clinical utility for genetic cancer tests

November 27, 2013 1:10 AM UTC

HHS's Agency for Healthcare Research and Quality said evidence supports the prognostic accuracy of several genetic tests that predict the risk of cancer recurrence, but said there is not enough evidence to determine whether the tests lead to improved outcomes. In a draft technology Oncotype DX breast cancer assay from Genomic Health Inc. (NASDAQ:GHDX) and MammaPrint breast cancer test from Agendia B.V. (Amsterdam, the Netherlands), as well as K-Ras (KRAS) testing for lung cancer and either BRAF testing or microsatellite instability for colorectal cancer.

However, according to AHRQ, there is no evidence to determine whether using the tests has clinical utility. The agency said that even when tests "seemed to add value in determining prognosis" that it "found no evidence that using the test was related to improved outcomes for patients." AHRQ noted that there is "moderate" evidence the Oncotype DX breast cancer assay leads to changes in treatment decisions but not that it has "an effect on downstream outcomes." The agency said there was insufficient evidence to evaluate the impact of MammaPrint on treatment decisions. The technology assessment is available for review until Dec. 12. ...