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Qiagen Claims Market Leadership in HPV Testing as Molecular Dx Business Drives Q2 Revenue Growth

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By Ben Butkus

Amid reporting a 9 percent spike in second-quarter revenues, Qiagen this week highlighted human papillomavirus testing as a key area of future growth for both its molecular diagnostics and overall business through expected sales of both consumables and instrumentation.

In addition, the company noted that it has maintained steady growth in the molecular diagnostics segment despite reduced testing demand in certain markets due to the current state of the economy; and told investors that it will delay the anticipated launch time of its higher throughput and fully automated QIAensemble Revolution platform for HPV and other molecular testing in an effort to make it more amenable to centralized testing labs.

Despite this, the company also laid down the gauntlet concerning the competitive landscape for HPV molecular testing, as CEO Peer Schatz called Qiagen the "undisputed market leader" in this category, and said that it expects to maintain this position as it continues to prepare QIAensemble Revolution for various markets over the next few months and years.

Overall, Qiagen's Q2 2010 net sales rose 9 percent to $262.7 million from $240.2 million in Q2 2009, and were buoyed by the company's molecular diagnostics business, whose revenues grew 12 percent year over year and were responsible for 47 percent of overall net sales.

In a statement, Schatz noted that molecular diagnostics "remains our strongest revenue driver even when considering the impacts related to swine flu testing in 2009," and that the market for Qiagen's profiling assays and solutions "remains very solid."

Schatz also said that the market for Qiagen's prevention assays — primarily HPV screening — "continues to benefit from our market adoption initiatives in the United States despite what is believed to be a temporary extension of doctor visit intervals. Anticipated future healthcare policies and reimbursement schemes worldwide promise a healthy outlook for this market segment."

In a subsequent conference call discussing Qiagen's Q2 financial results, Schatz added that there was "less than 40 percent penetration" for the HPV screening market worldwide; and that Qiagen was working toward further penetrating this market, particularly in the US.

Ensemble of Instruments

Qiagen's plan for such market penetration revolves around the development and forthcoming launch of its QIAensemble platform, a next-generation HPV DNA testing platform with enhanced instrumentation and automation to increase the speed and volume of the company's current "market-leading" HPV molecular test, Schatz said.

Currently, Qiagen offers the Digene HC2 HPV DNA test, which is based on hybrid capture 2 technology, a signal-amplification assay that the company claims is superior to PCR-based methods primarily because it better detects HPV that correlates to disease and not to the sheer presence of the virus.

The Digene test currently runs on Qiagen's Rapid Capture System, a semi-automated benchtop pipetting and microplate handling system for high-volume-throughput testing of up to 352 specimens and one to four microplates in an eight-hour shift.

Qiagen also offers the CareHPV test, a pared-down and easier-to-use version of the Digene HC2 HPV test that is intended for use in developing countries that lack the resources or technical expertise to run the Digene test. In July, Qiagen received the CE Mark for the CareHPV test, allowing the company to sell the test in developing countries that recognize the mark.

Meanwhile, QIAensemble describes a suite of products for sample preparation and automation of various Qiagen molecular tests. The current QIAensemble Evolution suite consists of automated modules for molecular sample prep from cellular HPV testing samples. The future QIAensemble Revolution will consist of the QIAensemble SP sample prep module and QIAensemble 400 or 2000 analyzer, depending on throughput need.

QIAensemble Revolution will "not only be designed for [the] HPV menu, but also assays for other parameters including [chlamydia and gonorrhea] and other assays based on tHDA," or helicase-dependent amplification technology, Thomas Theuringer, Qiagen's director of public relations, wrote this week in an e-mail to PCR Insider.

Qiagen said that the tHDA technology, which it licensed from BioHelix in 2008, will likely be combined with the HC2 detection technology in future testing platforms.

When QIAensemble is launched, Qiagen has said that it will offer HPV DNA testing for settings "ranging from rural health clinics with no electricity to sophisticated, high-throughput labs running thousands of HPV tests per day."

As reported by PCR Insider sister newsletter GenomeWeb Daily News, Schatz told investors at January's JP Morgan Healthcare Conference that the company had hoped for a 2010 launch of QIAensemble in Europe followed by a 2012 launch in the US.

This week, during the company's conference call, Schatz said that the European launch will likely be delayed until the first quarter of 2011; and that the US launch will likely be delayed from the third quarter of 2012 to the first quarter of 2013 to allow the company to add some technical features to the platform to make it more amenable to centralized testing laboratories.

Following the call, Theuringer explained Qiagen's strategy surrounding QIAensemble.

"We are currently seeing a new trend," Theuringer said. "In Europe, the value of our QIAensemble SP plus 2000 (and/or 400) is being seen [as] more and more significant, as the centralized testing model for primary screening with HPV DNA is a recently but rapidly emerging trend in HPV screening."

As such, Qiagen is now "making sure we get the perfect system for the centralized primary screening lab scenario in place at earliest time," Theuringer said, which involves accelerating various components to address large primary screening options in Europe; expanding the QIAensemble Evolution program; broadening the menu on QIAensemble concurrent with the launch of the HPV portfolio; and adding some technical features to the QIAensemble for the US markets.

"We reprioritized our programs and are therefore holding our US trials to include these features," he added. "The US version will benefit from this hold through acceleration of the broader menu of amplified and non-amplified assays on QIAensemble 400. We said we could see several months' delay, but believe that the added features significantly enhance our value proposition in both the US and in Europe."

Theuringer further noted that "in light of the competitive environment in US, launching with a complete menu is a higher-impact strategy and eliminates smaller projects that may slow us down in achieving our long-term goal of the menu-driven prevention system."

Market Leader

Even without commercial availability of the next-generation QIAensemble platform, Qiagen maintains that it is the market leader for HPV testing and that even its current technology is superior to others on the market.

Schatz said that Qiagen's competitors have been making a significant amount of noise regarding the performance of their HPV tests in scientific studies, especially in comparison to Qiagen's Digene HC2 HPV DNA test.

Notably, Roche Molecular Diagnostics recently presented data from a long-term trial that it said demonstrates that its HPV diagnostic, the Cobas 4800 HPV test, is as sensitive and specific as the Digene test.

However, Schatz noted that "it is clear that we have the performance-leading assay on the market" and that "no other assay comes close to being as validated to the extent of" the Digene test.

Referencing a presentation slide summarizing the HPV testing market, Schatz underscored the advantages of the Digene test in a number of categories such as sensitivity, specificity, sample handling, and throughput as compared to tests offered by competitors such as Roche, Hologic, and Gen-Probe.

Specifically, he said that the Roche test "highlights the Achilles' heel" of PCR-based testing in that it "misses HPV where the viral DNA is integrated" into the host genome.

Schatz also said that Gen-Probe's test, which uses transcription-mediated amplification technology to detect HPV mRNA and runs on its Tigris instrument, "has shown inferior sensitivity," and Qiagen further pointed out in its presentation that using RNA as an analyte is unvalidated. Meantime, Qiagen said that Hologic's test, which uses Invader chemistry, has shown excessive positivity, decreased specificity, and is slow.

In fact, according to Schatz, Qiagen's HPV testing market position is such that it has not seen an impact from what has widely been reported in the media as a decrease in testing volume due to decreased visits by patients to their physicians for routine testing.

Asked by an investor whether this phenomenon was sparking a decline in Qiagen's HPV test sales or allowing other competitors to gain traction in the market, Schatz said that "it is not necessarily impacting us directly … [and] we are not seeing competition. The economic value of a superior assay is very important."

Furthermore, Qiagen CFO Roland Sackers reiterated during the conference call that Qiagen's molecular diagnostics sales grew 12 percent year-over-year in Q2, largely driven by HPV testing; that this business grew sequentially from Q1; and that the company expects that it will have sequential growth over the next two quarters.

"This is not slow growth," Sackers said.

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