Regulatory Focus™ > News Articles > NICE Green Lights Two IVDs Intended to Detect Lung Cancer

NICE Green Lights Two IVDs Intended to Detect Lung Cancer

Posted 10 April 2013 | By Louise Zornoza

The UK cost containment agency, the National Institute for Health and Care Excellence (NICE), recommended on 9 April 2013 reimbursement for two in vitro diagnostic (IVD) devices for detecting epidermal growth factor receptor-tyrosine kinase (EGFR-TK) mutations in the tumors of adults with previously untreated, locally advanced or metastatic non-small-cell lung cancer (NSCLC). 

The two diagnostic tests, Qiagen's Therascreen EGFR RGQ PCR Kit and Roche's Cobas EGFR Mutation Test, are recommended as options for use in accredited laboratories participating in an external quality assurance scheme. 

Due to insufficient evidence, the Committee could not make any recommendations on five further EGFR-TK mutation tests: high-resolution melt analysis, pyrosequencing combined with fragment length analysis, single-strand conformation polymorphism analysis, next-generation sequencing, and the therascreen EGFR Pyro Kit (CE-marked, Qiagen).

Non-small-cell lung cancer (of which there are three different types, called squamous cell carcinoma, adenocarcinoma and large cell carcinoma) is the most common type of lung cancer, accounting for around 88% of all cases.  Small cell lung cancer accounts for around 12% of all cases. Small cell lung cancer is more aggressive than non-small-cell lung cancer, and it usually spreads faster.  Lung cancer is the second most common cancer (after breast cancer) in England and Wales. An estimated 40,800 new cases are diagnosed every year.

Tags: HTA, CER, UK

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