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Qiagen Gets FDA Approval for CMV Assay on QiaSymphony Platform

NEW YORK (GenomeWeb) – Qiagen said today that its Artus CMV QS-RGQ molecular diagnostic kit for use on the QiaSymphony platform has received premarket approval from the US Food and Drug Administration.

The real-time PCR assay is designed to be used with human plasma samples, and is intended to aid in the management of solid organ transplant patients who are undergoing anti-cytomegalovirus therapy.

The new approval is a migration of the Artus CMV QS-RGQ kit to Qiagen's fully automated, sample-to-answer QiaSymphony platform. The kit was previously approved by the FDA for use on Qiagen's Rotor-Gene Q real-time PCR platform, which is one component of the QiaSymphony platform.

Qiagen said that clinical laboratories with higher sample volumes will benefit from faster, higher-throughput processing with the QiaSymphony workflow, while lower-volume labs that send out all or part of their current CMV tests may now be able to bring CMV and transplant testing in house.

"This application of our Artus CMV kit on the QiaSymphony automation system will be an important catalyst to strengthen this comprehensive portfolio," Thierry Bernard, senior vice president of molecular diagnostics at Qiagen, said in a statement. "This kit will allow Qiagen to serve a new group of higher-volume CMV test customers, while providing our dedicated QiaSymphony base of customers a new test that will help them handle growing CMV test volumes."