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Dx Focus: FDA Approves Qiagen Therascreen EGFR RGQ; Luminex xTAG CYP2D6 Kits

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Qiagen has received US Food and Drug Administration approval for its Therascreen EGFR RGQ PCR kit, a companion diagnostic to guide the use of Boehringer Ingelheim's new targeted therapy, Gilotrif (afatinib), for treatment of metastatic non-small cell lung cancer in patients whose tumors have certain EGFR gene mutations.

Gilotrif is indicated for NSCLC patients whose tumors express EGFR exon 19 deletions or exon 21 L858R substitution gene mutations, the most common mutations in the EGFR gene. Qiagen said that NSCLC accounts for 85 percent of the 200,000 new cases of lung cancer diagnosed in the US each year and leads to an estimated 160,000 deaths.

The company submitted the Therascreen EGFR test to FDA in January. This is the third FDA-approved or cleared diagnostic kit for Qiagen's Rotor-Gene Q real-time PCR instrument, and is the second FDA-approved companion diagnostic to run on the system, Qiagen said.

Rotor-Gene Q MDx received 510(k) clearance from the FDA in April 2012. The first Therascreen test to receive FDA approval was Therascreen KRAS, which was approved last year as a companion diagnostic for Erbitux (cetuximab) for treating colorectal cancer patients.


Luminex said this week that it has received US Food and Drug Administration and EU clearance for a new version of the xTAG CYP2D6 kit.

The kit is an in vitro diagnostic assay that analyzes a patient's CYP2D6 genotype from DNA extracted from a blood sample to aid physicians in determining therapeutic strategy for drugs metabolized by the cytochrome P450 2D6 gene product. The assay is run on the Luminex 100/200 instrument.

The new version of the kit optimizes performance on the *17 allele and features an updated software algorithm that detects all 17 genotypes that the assay is cleared for, including deletion and duplication genotypes.

Luminex also said this week that it has submitted the xTAG CYP2C19 kit to the FDA for review and for CE clearance in the EU. The CYP2C19 enzyme is responsible for metabolizing a variety of prodrugs and drugs used to treat ulcers, seizures, malaria, and anxiety. It is also partially responsible for metabolizing drugs such as beta-blockers and some antidepressants.

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