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MDx/CDx Focus: Myriad's PROCEDE 500 Prolaris Study Data; EntroGen Updates NRAS, KRAS Tests


Myriad Releases Interim PROCEDE 500 Clinical Utility Trial Data for Prolaris

Myriad Genetics presented interim results from the PROCEDE 500 clinical utility study for its Prolaris test at a medical conference this week showing that the prognostic prostate cancer diagnostic influenced the type of treatment strategy doctors pursued for the majority of their patients.

At the ASCO Genitourinary Cancers Symposium in San Francisco, Calif., researchers from Myriad reported that to date 150 physicians have completed surveys about how Prolaris influenced their treatment strategies for more than 300 prostate cancer patients. Overall, for 65 percent of patients, the doctors took a different treatment strategy based on Prolaris test results than they were going to pursue before testing.

Physicians chose to reduce their level of treatment and manage 40 percent of patients more conservatively based on Prolaris results. For 25 percent of cases, the test results spurred doctors to ramp up their intervention to performing surgery or treating patients with radiation. Doctors didn't change their treatment plans based on test results for 35 percent of patients.

Myriad is marketing Prolaris as a test that can help doctors determine which prostate cancer patients are at risk of aggressive prostate cancer and which are likely to have indolent disease. The test gauges the expression of 31 cell cycle progression genes and 15 housekeeper genes.

The firm is planning to publish complete results from PROCEDE 500 in a peer-reviewed journal. Myriad is also hoping that the data from this study will convince the Centers for Medicare & Medicaid Services to cover Prolaris for the Medicare population. Industry observers have estimated that in order to garner Medicare coverage, Myriad will need to show that when doctors used Prolaris, they changed at least 20 percent of treatment decisions based on test results.

EntroGen Updates KRAS, NRAS Tests With New Mutations

EntroGen announced that it has updated its KRAS and NRAS Mutation Analysis kits to include detection of exon 2, 3, and 4 mutations.

The latest version of the real-time PCR kits cover all known mutations in codons 12, 13, 59, 61, 117 and 146 of the KRAS and NRAS genes, as well as the BRAF V600E mutation. These tests, with CE IVD marking in EU countries, are currently available for colorectal cancer screening.

“The importance of mutations in exons 3 and 4 of KRAS and 2, 3 and 4 of NRAS were demonstrated in a randomized, multicenter Phase III study published in 2013, where researchers from Amgen identified them as markers of innate resistance to panitumumab (Vectibix) in addition to the already known exon 2 mutations in KRAS,” EntroGen said in a statement.

Amgen has said it is working with Qiagen and is using Illumina's MiSeqDx to develop companion tests for Vectibix.