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July 14, 2015

FDA approves Qiagen’s therascreen EGFR test for use with Iressa

Qiagen has secured US marketing (PMA) approval to use its therascreen EGFR RGQ PCR Kit as a companion diagnostic to guide the use of AstraZeneca's Iressa in the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC).

Qiagen has secured US marketing (PMA) approval to use its therascreen EGFR RGQ PCR Kit as a companion diagnostic to guide the use of AstraZeneca’s Iressa in the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC).

The US Food and Drug Administration (FDA) cleared the test to enable doctors to identify NSCLC patients who have tumours that are positive for epidermal growth factor receptor (EGFR) mutations and are eligible for treatment with Iressa.

Qiagen Molecular Diagnostics Business Area senior vice-president Thierry Bernard said: "The FDA approval of our therascreen EGFR test with Iressa is another highlight in Qiagen’s ongoing, successful collaboration with AstraZeneca.

"The FDA approval of our therascreen EGFR test with Iressa is another highlight in Qiagen’s ongoing, successful collaboration with AstraZeneca."

"As the second FDA-approved use of therascreen EGFR in NSCLC, the pairing with Iressa also expands Qiagen’s US market leadership in EGFR testing."

AstraZeneca Personalised Healthcare and Biomarkers vice-president Ruth March said: "By combining AstraZeneca’s expertise in lung cancer with QIAGEN’s leading diagnostic technologies, we have the potential to help physicians achieve better patient outcomes in NSCLC."

Besides therascreen EGFR test, Iressa was also authorised for first line treatment of NSCLC in patients identified with the help of an FDA-approved companion diagnostic. The drug is currently marketed in more than 90 countries.

Launched in more than 30 European countries in January, the therascreen EGFR Plasma RGQ PCR Kit analyses EGFR mutation status from blood and is claimed to be the first-ever ‘liquid biopsy’ regulatory registration of a companion diagnostic to benefit solid-tumour patients for whom surgical biopsies are not assessable.

Developed by Qiagen Manchester, the kit was marketed as a companion diagnostic for another drug used in NSCLC patients in the US since 2013.

More than 200,000 new lung cancer cases are diagnosed annually in the US, with NSCLC accounting for nearly 85% of cases, resulting in an estimated 160,000 deaths.

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