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Qiagen EGFR Assay Approved in Japan as CDx to Pfizer NSCLC Drug

NEW YORK (GenomeWeb) – Qiagen said Wednesday that its Therascreen EGFR RGQ PCR kit has been approved by the Japanese Pharmaceuticals and Medical Device Agency as a companion diagnostic with Pfizer's Vizimpro (dacomitinib) for EGFR mutation-positive, inoperable, or recurrent non-small cell lung cancer.

Qiagen's test detects the most frequently occurring somatic mutations (exon 19 deletions, L858R, L861Q, G719X, S768I, exon 20 insertions, and the resistance mutation T790M) in EGFR in less than four hours using real-time PCR on the Rotor-Gene Q platform, a module in Qiagen's QiaSymphony family of instruments.

The kit is registered in more than 40 countries, and it is Qiagen's first companion diagnostic approval in Japan.

"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," Jonathan Arnold, vice president and head of oncology and precision diagnostics for Qiagen, said in a statement.

The Scan

Enzyme Involved in Lipid Metabolism Linked to Mutational Signatures

In Nature Genetics, a Wellcome Sanger Institute-led team found that APOBEC1 may contribute to the development of the SBS2 and SBS13 mutational signatures in the small intestine.

Family Genetic Risk Score Linked to Diagnostic Trajectory in Psychiatric Disorders

Researchers in JAMA Psychiatry find ties between high or low family genetic risk scores and diagnostic stability or change in four major psychiatric disorders over time.

Study Questions Existence of Fetal Microbiome

A study appearing in Nature this week suggests that the reported fetal microbiome might be the result of sample contamination.

Fruit Fly Study Explores Gut Microbiome Effects on Circadian Rhythm

With gut microbiome and gene expression experiments, researchers in PNAS see signs that the microbiome contributes to circadian rhythm synchronicity and stability in fruit flies.