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Dx Focus: Japan Approves Qiagen's Therascreen EGFR kit; NIST Releases CMV Standard Reference

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Qiagen said this week that Japanese regulators have approved the company's Therascreen EGFR Mutation Detection Kit as a companion diagnostic for drugs targeting non-small cell lung cancer.

Qiagen's PCR-based EGFR assay determines the presence or absence of an EGFR mutation in a patient's tumor to help guide treatment with EGFR inhibitors. Qiagen cited studies demonstrating that patients who are tested for EGFR mutation status can experience 60 percent response rates to such therapies, which it said was a "much higher" response rate than with chemotherapy.

In Japan and East Asia, a test for EGFR mutations could be especially meaningful because populations in the region have a higher rate of EGFR mutations in general, Qiagen said. Non-smoking women in East Asia represent the largest potential market for EGFR-inhibitor oncology drugs, the company added.

The approval means Qiagen will be able to market its kit in Japan with drug firms that offer certain EGFR inhibitors.


The National Institute of Standards and Technology has released a new standard reference material to help healthcare providers more accurately diagnose and treat cytomegalovirus.

CMV is found in 50 percent to 80 percent of the population. It is a member of the herpes family of viruses, and generally remains latent in an infected person unless certain conditions trigger its activation.

Antiviral therapy is currently guided by viral load, which is most often measured using PCR, NIST said. However, the accuracy of these measurements can vary greatly from one test facility to another due to the use of different PCR protocols from lab to lab, including commercial and laboratory-developed assays.

The new NIST reference, SRM 2366, addresses the variability problem by providing a standardized CMV DNA. NIST ensured consistency of the viral DNA in the standard by manufacturing it in Escherichia coli bacteria.

SRM 2366 consists of three solutions, each with a specific concentration of CMV DNA copies/mL: 420, 1,702 and 19,641. These are designed to qualify prepared calibration samples, and can be used as quality control samples for diagnostic equipment. For added traceability, the SRM certificate of analysis includes the genetic sequences of the nine CMV genome regions copied for the standard, NIST said.

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