Glen Mackenzie, global business director, HPV
Michael Farmer, associate director

With its recent acquisitions of artus and Digene, QIAGEN, Germantown, Md, has made rapid inroads into the molecular testing arena. In addition to assays, the company also provides sample-extraction technologies, including the automated platform QIAsymphony. CLP recently spoke with QIAGEN’s Glen Mackenzie, global business director, HPV, and Michael Farmer, associate director, assays, about the status and future of HPV testing and molecular diagnostics.

CLP: How does QIAGEN see itself fitting into the molecular landscape, and how did molecular diagnostics get started at QIAGEN?

Mackenzie: From a molecular landscape perspective, QIAGEN is a well-diversified company in that it allows customers the opportunity to generate results all the way from sample collection to extraction to detection. We are providing an expanding menu of assays in the clinical markets.

CLP: How did QIAGEN segue from sample prep and extraction to assays, in terms of choosing what to develop and acquire?

Mackenzie: A few years ago, the company acquired the artus line of products, which gave us the opportunity to enter into the infectious disease market with a variety of molecular assays. The recent acquisition of Digene provides access into the clinical laboratory with the HPV assays, as well as the CT and GC assays that Digene had as part of its portfolio.

It has been over a year since the acquisition occurred, so the businesses have been fully integrated and what we’re seeing now is the synergies of the two companies. We’re now in a position to take advantage of the strong HPV assay that Digene had, and also to take advantage of the very strong sample-preparation and extraction technologies that QIAGEN possesses.

We’re in the process of getting ready to provide customers with solutions for automating the extractions associated with liquid-based cytology, which is the predominant sample type for HPV testing in the United States. QIAGEN has an instrument called the QIAsymphony, released last year, and we are now planning our clinical trials in order to automate the extraction process and make it easier for customers to run the HPV assay.

CLP: What is the projected launch date for this HPV QIAsymphony upgrade?

Mackenzie: We’re looking to have the clinical trials begin in the second half of 2009, and the timing of the launch will depend on the FDA review period.

CLP: Where do you see QIAGEN fitting in with what else is out there in HPV testing?

Farmer: Right now in the United States, we’re still the only FDA-approved HPV test on the market. However, there is competition coming from major diagnostic players, especially in Europe. It goes back to the trends in the marketplace. The amount of testing is increasing, the med tech labor force is shrinking, and labs are looking to improve efficiency. They need more productivity from their platform and less labor input, which drives more fully automated systems from samples to results and more assays on the platforms.

CLP: Can you address how the volume of HPV testing has increased over the previous years to the previous decade? What can we expect moving forward?

Farmer: It’s increased substantially over the last decade. HPV is still a high growth market, the penetration rate into the screening market is about 30% right now in the United States. There remains a lot of potential for conversion from traditional ways of cervical screening.

CLP: What kind of growth do you expect moving forward, and what do you think are going to be the main drivers of that growth?

Mackenzie: Right now we’re continuing to see double-digit growth in the HPV market, and I think there are probably a couple of different drivers, one being patient education. With a lot of different activity from the vaccine companies—who are certainly making women more aware of HPV as an issue—I think more women are asking about the test, and that’s helping to contribute to some of the increased demand. I think there is also increased physician awareness, and I think that is a key driver in the increase in the number of test requests we’re seeing.

CLP: So you would say the availability of the vaccine has accelerated the request for testing?

Farmer: It’s increased the awareness.

Mackenzie: I think that as the demand for the test increases, the thing we’re focusing on from a customer-driven design goal is to try to automate the testing as much as possible, and that will include the front-end sample preparation and extraction from liquid-based cytology media. But it will also provide customers with highly automated detection systems that will offer them a broad menu of tests, including HPV genotyping, Chlamydia, and gonorrhea, as well as other women’s health assays that we’re looking to develop in the future, and really to be able to provide customers with the opportunity to consolidate the workstations they’re using in their molecular laboratories. It’s really only possible if you provide customers with instruments that have high sample capacity, high sample reagent capacity, and high throughput, and that’s what we’re working to deliver.

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CLP: What new products should labs look for from QIAGEN in the near future?

Mackenzie: As I mentioned, the QIAsymphony with automated extraction is going to have the clinical trials start this year and hopefully be approved by the FDA in 2010. We’re going to be providing customers with a genotyping solution so that they can have the ability to ID those women who are positive for some of the clinically significant high-risk types. That will be a nice complement to the existing hybrid capture screening assay, because it will provide the physician some direction as to whether or not they need to manage these patients differently. Genotyping products can be expected in the June/July time frame.

CLP: What do you think will be the effects of the recently passed stimulus bill on the development of molecular diagnostics?

Farmer: I think the increased funding will certainly drive the development of more molecular diagnostic applications—through discovery, through applications and development, and even through validation. Molecular diagnostics remains the highest growth segment in the IVD industry, and it’s really driven by improved health care. I think that as long as health care remains a priority, we would expect to see continued growth in the molecular diagnostic field.

Suzanne Clancy, PhD, is editor of CLP.