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Following FDA OK for MDx System, C. Diff Test, Qiagen to Rapidly Expand Test Menu to Drive Growth

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NEW YORK (GenomeWeb) — Qiagen has achieved a major milestone in its efforts to expand uptake of its QIAsymphony RGQ molecular diagnostics system, as the company disclosed this week that the platform recently received 510(k) clearance from the US Food and Drug Administration.

The system was cleared along with its first assay, the Artus C. difficile test, which is designed to aid in the diagnosis of Clostridium difficile infections by detecting Toxins A and B, and was developed by IMDx under a multi-year agreement signed by the companies in early 2013.

And the C. difficile assay is just the tip of the iceberg for Qiagen, as the company plans to rapidly expand QIAsymphony's menu over the coming year by either launching in Europe or submitting for US regulatory clearance as many as 10 additional assays for infectious diseases, particularly in the area of hospital-acquired infections and women's health.

Qiagen CEO Peer Schatz discussed these developments and more during a conference call held this week to discuss the company's first quarter 2014 earnings, a full recap of which can be found here. In Q1 Qiagen tallied overall sales of $317.1 million, up 4 percent from $303.6 million in Q1 2013.

"The QIAsymphony RGQ MDx system is a modular platform that comprises the QIAsymphony SP for sample preparation, the QIAsymphony AS for assay setup, and the Rotor-Gene Q thermal cycler, which received FDA clearance in 2012. While the platform has a broad menu in Europe and other markets — around 25 tests — until now it has been used only for laboratory-developed assays in the US.

"Gaining clearance for all three components of the QIAsymphony system … is an important step towards increasing the utility of this … modular automation platform for customers," Schatz said during the call.

"More test menu expansion is on the way," Schatz added. "We are in the process of doing the 510(k) submission for the Artus VanR QIAsymphony RGQ kit for healthcare-associated infections from vancomycin-resistant bacteria. We have also completed the CE-IVD [process] for this kit."

Other submissions planned for the year include a US application for an Artus assay for herpes simplex virus 1 and 2, and also US and European applications for an Artus assay kit to detect methicillin-resistant Staphylococcus aureus infections.

According to presentation slides accompanying Qiagen's earnings call, the firm also has submitted a pre-market approval application in the US for a cytomegalovirus assay, which has already launched in Europe; and plans 2014 US regulatory submissions and European clearances for a group B Streptococcus test and Trichomonas assay.

Moving out of infectious diseases and into personalized cancer therapy, the company is also eyeing 2014 launches in Europe for companion diagnostic assays for JAK2, KRAS (for non-small-cell lung cancer), and BCR-ABL, although it did not provide a timeline for US regulatory submissions for these tests.

During the conference call, an analyst queried Schatz regarding the markets that Qiagen would be targeting with QIAsymphony as it ramps up the test menu,

"If you think of this as a complete portfolio across HAI, it is a pretty powerful proposition," Schatz said. "The availability of a broad menu makes it very attractive to laboratories that are providing a wide range of different tests, in particular, in hospitals. The ability to do random-access continuous load testing gives it some very unique features, low cost of capital, [and a] very broad menu but still allows quite a sizable throughput of testing at a very attractive cost."

As such, Schatz noted, the company is primarily targeting a "classic medium-throughput" hospital market in terms of HAI testing.

Meantime, Schatz added, the system can also serve higher-throughput customers. "We've also seen some demand coming in there with some of the more expensive … patient tests [where] … the central laboratory takes a strong role in providing these tests in a centralized format, which is very often in hospitals and also other types of healthcare settings, so quite an attractive proposition," Schatz said. "Some labs are actually doing very high throughput testing even with C. diff."

The analyst also asked whether current QIAsymphony platform owners would be able to begin adopting some of these tests on their current platform, or whether they would need to acquire a new QIAsymphony system.

"The systems that are out there [and] the QIAsymphony RGQ system that we've now got FDA clearance for [are] identical … with the exception that, in some cases, the cycler would need a software upgrade … to reflect the newest version of the software that was included in the clearance," Schatz said. "So it's quite an easy migration path that can be performed."

The rapid expansion of its QIAsymphony platform menu — as well as the uptake of its QuantiFeron rapid tuberculosis test, which the company launched in China in March — comes at an opportune time for Qiagen, as it has continued to absorb withering sales of its molecular test for human papillomavirus in the face of stiffening competition.

In Q1, sales within the company's molecular diagnostics customer class, which constitutes 48 percent of sales at the company — by far its largest customer class — grew 1 percent at constant exchange rates. This growth was despite a 27 percent decline in HPV testing sales.

"US sales of HPV testing products declined about 27 percent in the first quarter, and represented about 9 percent of total sales, and this was in line with our full-year expectations as we absorbed the impact of pricing pressure and the non-exclusive transition of a US customer to a competitive test," Schatz said during the call, referring to HPV testing rival Hologic's strategic alliance with Quest Diagnostics, disclosed last June. "As for HPV sales in the rest of the world, we have been very successful in winning by far most of the new tenders, but saw delivery timing impact results in the first quarter."

Qiagen noted that its QuantiFeron latent TB test maintained its pace of growing above 20 percent CER and provided approximately 7 percent of total sales at the firm. Meantime, the growing installed base of QIAsymphony automation platforms drove double-digit CER growth of profiling consumables, Qiagen said. The company also noted that personalized healthcare sales growth was led by rising contributions from companion diagnostic assays, all of which are currently run using the QIAsymphony RGQ platform, but the firm did not break out numbers for these sales.

Schatz also noted during the call that the company saw "outstanding growth in applied testing" from double-digit growth in both consumables and instruments, with a "key driver" being consumables contributions from QIAsymphony RGQ placements in 2012 and the ongoing expansion of the company's human identification and forensics business.

All in all, Qiagen is on track to achieve its goal of placing about 250 QIAsymphony RGQ systems in 2014, which would add to the more than 1,000 cumulative placements the company had at the end of 2013, Schatz said during the call.

As in previous earnings calls, Schatz pointed to QIAsymphony as one of five major growth drivers at the company, with the others being personalized healthcare (companion diagnostic tests based on the QIAsymphony and other future molecular analysis platforms); QuantiFeron-TB, which detects interferon gamma release as a proxy for early detection of latent tuberculosis; bioinformatics, including contributions from recent acquisitions Ingenuity and CLC Bio; and sequencing, which the company jumped into when it acquired privately-held Intelligent Bio-Systems in 2012. Additional information about Qiagen's sequencing commercialization timeline can be found in a story published this week in In Sequence.

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