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UK Agency Recommends Roche, Qiagen Tests, Sanger Sequencing for Some NSCLC Patients

NEW YORK (GenomeWeb News) – The UK agency advising the National Health Service which tests it should make available to the public on Tuesday recommended five tests and testing technologies for certain patients with non-small cell lung cancer.

In a final guidance, the National Institute for Health and Care Excellence, or NICE, recommended the tests for detecting epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutations in tumors of adults with previously untreated, locally advanced, or metastatic NSCLC to inform first-line decisions.

The tests recommended are Qiagen's Therascreen EGFR RGQ PCR Kit; Roche's Cobas EGFR Mutation Test; Sanger sequencing of samples with more than 30 percent tumor cells and Therascreen EGFR RGQ PCR Kit for sample with lower tumor cell contents; Sanger sequencing of samples with more than 30 percent tumor cells and Cobas EGFR Mutation Test for samples with lower tumor cell contents; and Sanger sequencing followed by fragment length analysis and PCR of negative samples.

NICE declined to recommend five other technologies because of "insufficient evidence," however. They include next-generation sequencing; Qiagen's Therascreen EGFR Pyro Kit; pyrosequencing combined with fragment length analysis; single-strand conformation polymorphism analysis; and high resolution melt analysis.

Qiagen's Therascreen EGFR RGQ PCR Kit is a CE-marked real-time PCR assay that detects 29 mutations in exons 18 and 21 of the EGFR-TK gene. In July, the US Food and Drug Administration approved the assay as a companion diagnostic for Boehringer Ingelheim's Gilotrif (afatinib) for treating NSCLC patients with tumors with certain EGFR mutations.

Roche's Cobas EGFR Mutation Test also is a CE-marked real-time PCR test and detects 41 mutations in exons 18 and 21 in the EGFR-TK gene. In May, FDA approved the assay as a companion diagnostic for Tarceva (erlotinib), jointly marketed in the US by Roche's Genentech business and Astellas Pharma.

In a statement, Roche said that while there are many different types of tests for EGFR-TK mutations being used in NHS labs in England, NICE aimed at identifying the "most clinically and cost-effective tests that should be used to inform first-line treatment decisions."

The prices charged by NHS labs for the five recommended tests ranged from £130 ($202) for Sanger sequencing for Roche's Mutation Test for samples with insufficient tumor cells, to £154.58 ($239.73) for Qiagen's test, NICE said.

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