Qiagen, a provider of sample and assay technologies for molecular diagnostics, has secured approval for EGFR test in lung cancer as companion diagnostic in Japan.
The Japanese Pharmaceuticals and Medical Device Agency (PMDA) has approved the therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic with Pfizer’s VIZIMPRO (dacomitinib) for EGFR gene mutation-positive, inoperable or recurrent non-small cell lung cancer.
The therascreen EGFR RGQ PCR Kit is claimed to have been registered in more than 40 countries across the globe and it is the first companion diagnostic approval for the company in Japan.
Qiagen vice president and oncology and precision diagnostics head Jonathan Arnold said: “As precision medicine becomes the standard of care in oncology, we are pleased to provide benefits to more lung cancer patients with our clinically proven therascreen EGFR RGQ PCR Kit. Our collaboration with Pfizer has made great strides already and will continue to improve personalized healthcare for patients around the world.
“In addition to detecting a comprehensive panel of EGFR mutations, the therascreen EGFR kit offers laboratories an efficient workflow on the Rotor-Gene Q MDx, the real-time PCR module in our widely-used QIAsymphony family of instruments.”
The therascreen EGFR RGQ PCR is a molecular diagnostic kit for detection of exon 19 deletions, L858R, L861Q, G719X, S768I, exon 20 insertions, and the resistance mutation T790M in the EGFR gene using real-time PCR on the Rotor-Gene Q 5plex HRM instrument.
The kit offers all the necessary reagents and has been designed for rapid and sensitive detection of low percentage of mutant DNA in a background of wild-type genomic DNA. This technology, when combined with Scorpions detection technology is claimed to offer high sensitivity and specificity for the detection of specific mutations.
This kit is compliant with EU IVD Directive 98/79/EC. It has clinically validated using samples from the LUX-Lung III trial.
Qiagen, the Germany-based medical technology company, collaborates with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect genetic abnormalities to offer insights into the clinical decision-making on the use of drugs in diseases such as cancer.