Qiagen this week announced that it has received 510(k) clearance from the US Food and Drug Administration for its Rotor-Gene Q MDx real-time PCR instrument and a compatible test for influenza A/B, the Artus Infl A/B RG RT-PCR kit.
The approval allows the firm to sell the instrument and the assay for in vitro diagnostic use in the US market and lays the groundwork for it to expand its IVD test menu for the system.
Qiagen has been marketing the Rotor-Gene for IVD use in Europe as part of its CE-marked QIAsymphony RGQ platform and has also secured regulatory clearance in China, Japan, Korea, Brazil, and elsewhere for various Rotor-Gene models, but FDA approval of the instrument is a "milestone" for the company, CEO Peer Schatz said in a statement.
"Outside the US, our customers already have access to a broad portfolio of molecular diagnostic tests for use on these platforms," Schatz said. "The FDA clearances now pave the way to make this market-leading assay portfolio available to clinical laboratories in the US as well.”
Qiagen is selling the FDA-approved version of the instrument under the name Rotor-Gene Q MDx, and continues to sell the Rotor-Gene Q for research use in the US. The 510(k) approval is only for the standalone instrument and does not extend to the entire automated QIAsymphony RGQ platform. Christoph Menzel, associate director for Rotor-Gene Q MDx systems at Qiagen, told PCR Insider that the company intends to seek US approval for the entire QIAsymphony RGQ platform but did not provide a timeline for doing so.
Menzel estimated that the company currently has a Rotor-Gene installed base of "a couple hundred in the US for research purposes, and a couple thousand worldwide for IVD purposes."
The company expects to see a boost in the US IVD market since it views the Rotor-Gene as uniquely suited for the clinical lab environment. The rotary format of the system enables samples to circle rapidly through the PCR reaction chamber. "Due to this movement it is highly thermally uniform, so that means that every sample is exactly the same temperature at each time point of the qPCR cycle," Menzel said.
This feature, he said, is very important "in an IVD environment where you want to compare controls and samples with each other."
Menzel said the sample-to-answer workflow for the Rotor-Gene Q MDx is about two and a half hours, including about 45 minutes for extraction, and a cycling run of about an hour and a half.
The assay menu for the platform should expand rapidly over the next several years. The company has already filed for FDA approval of its Therascreen KRAS assay as a companion diagnostic for the colorectal cancer drugs Erbitux and Vectibix. Approval for the assay, which runs on the Rotor-Gene Q MDx, is expected sometime this year.
Thomas Theuringer, director of public relations for the company, said that while its plans are subject to change, Qiagen expects to submit for approval this year a Therascreen EGFR assay, as well as a PCR-based Artus cytomegalovirus assay and a CMV assay for the Quantiferon technology it acquired via its purchase of Cellestis last year.
Theuringer said that in 2013 and beyond, the company is eyeing FDA approval for Artus assays for Chlamydia trachomatis and Neisseria gonorrhoeae, human immunodeficiency virus, and hepatitis C virus; and Therascreen tests for BCR-ABL, KRAS mutations for lung cancer indications, and JAK2.
Menzel said that the FDA approval process for the instrument and flu assay took around three months, which was along the lines of what the company had expected.
The FDA's 510(k) notification documents note that the agency used Abbott Molecular's m2000rt system as the predicate device for the Rotor-Gene Q MDx and Gen-Probe's ProFlu+ Assay as the predicate device for the Artus flu A/B assay.
Qiagen faces a number of competitors in the flu testing market. In addition to Gen-Probe's test, which runs on Cepheid's SmartCycler, a number of firms, including the Focus Diagnostics arm of Quest Diagnostics, Cepheid, and Quidel, have secured FDA 510(k) approval for influenza assays over the last few years for use on a range of PCR platforms.
Carsten Lange, global product manager for the Artus influenza kit, conceded that the flu market is competitive, but noted that FDA approval of both the instrument and the assay should give the firm an advantage.
Many assay developers, he said, "rely on third-party instrumentation for their cycling purposes, [whereas] we can offer the whole workflow with one support line for the customer to call" if they have questions.
"Even though the flu market in the US may be crowded, I can certainly say that we are in a very good position having not only the assay but also the instrumentation to go with it," he added.
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