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Qiagen's Dietrich Hauffe on Bringing Next-Generation Sequencing to Clinical Research and Molecular Dx

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Haufe2.jpgName: Dietrich Hauffe
Age: 53
Position: Senior vice president and head of life sciences business area, Qiagen, since 2012
Experience and Education:
Vice president of marketing, applied testing; then vice president of marketing, life sciences, Qiagen, 2010-2012
General manager, Germany; later vice president of global marketing and business development, Dionex, 2000-2009
Senior product manager in automation, Qiagen, 1997-2000
Various positions, Dionex, 1993-1997
Postdoctoral fellow, University of Freiburg, 1991-1993
PhD, Max-Planck-Institute of Plant Breeding, Cologne, 1988
Undergraduate degree in genetics and biochemistry, University of Bochum

A year ago, Qiagen publicly announced its plans to create a portfolio of next-generation sequencing products for use in clinical research and molecular diagnostics. As part of this initiative, the company acquired Intelligent Bio-Systems, a Massachusetts-based start-up that had been developing a sequencing-by-synthesis platform with chemistry developed at Columbia University (CSN 6/27/2012).

Last fall, the company launched a number of sequencing-related reagent kits, including several cancer gene panels (CSN 11/7/2012), and in February, it said that its new sequencing system, the GeneReader, will be available to early access customers later this year (IS 2/26/2013). The initial system will consist of a QiaCube for sample preparation, a QiaCube NGS for library amplification, and the GeneReader, and will be supported by variant analysis and interpretation software from Ingenuity, which Qiagen acquired in April (GWDN 4/30/2013).

Clinical Sequencing News visited Qiagen's headquarters in Hilden near Düsseldorf in Germany this week and spoke with Dietrich Hauffe, the company's senior vice president and head of the life sciences business area, about Qiagen's plans in next-gen sequencing. Below is an edited version of the conversation.


Why did Qiagen decide to develop a product portfolio around next-generation sequencing?

The overall development goes back to the history of Qiagen. We started off with sample preparation, we went into assay technologies, we went into gene panels through our franchise in Frederick, [Maryland], via GeneGlobe. And being an enterprise that covers both life sciences as well as molecular diagnostics, we saw this as a white spot in our overall portfolio. So it was pretty obvious for us to jump onto technologies that seem to grow in importance for life sciences as well as for molecular diagnostics. And since our path has been leading into the translational part of research, next-gen sequencing was definitely one of the very important factors to fill our gap here.

Why did Qiagen decide to acquire its own sequencing platform, rather than build products around an existing platform?

We love to be complete, and in our portfolio strategy you don't necessarily see a big gap. I strongly believe there is a great opportunity for us, based on this prototype that we brought in from IBS. Only by doing this, we can improve our chemistries, our sample preparation technologies, because we have everything in our product line. Taking the vision we have, from sample to insight, we look at the whole flow. If the piece in the middle is missing, it just doesn't make sense. And since we have the capabilities, the sequencing knowledge and everything, in house, why should we not go for it?

Where do you see the greatest market opportunity for next-gen sequencing right now?

What we develop as technology in life sciences eventually will become evident in molecular diagnostics. So our competencies around panels, around biomarkers, around technologies will in the end flow into the area of diagnostics. While we have done certain acquisitions in the diagnostics area, we think that the translational part, which basically bridges life sciences discovery and routine molecular diagnostics, including our applied sciences, is going to be filled with next-gen sequencing as a detection platform for the future.

Where do you see opportunities for next-gen sequencing in molecular diagnostics?

Not only cancer research but also cancer diagnostics; infectious disease research as well as the diagnostics of infectious diseases; anything around food safety has a certain impact as well. In human diagnostics, we are looking at cancer, dementia in the future, anything where studies can prevent certain diseases to break out, where preventative medicine can help. We also look at molecular diagnostics in the applied sciences, where we talk about food safety, human identification and forensics, and even in livestock.

How much will next-generation sequencing compete with or complement qPCR-based molecular diagnostic assays?

I strongly believe, which might be different from others' opinions, that both technologies will remain, depending on the way you need to gather information. For a very well-known disease, which is related to one, two, or three mutations, there is no need for NGS. However, if you have a certain complexity in your disease, and there is even more complexity because of different treatments, variety of patients, and outbreak of diseases, areas where not very much is known, then NGS will play a substantial role. Will it replace qPCR? No, I don't think so. I think it's a parallel approach, I think it's a complementary technique. And where routine pricing comes into play, I think qPCR is definitely not going to be replaced by NGS.

Can you talk about the process that led to the acquisition of Intelligent Bio-Systems?

Before we acquired IBS, we were looking into this technology for two to three years. We looked at all the technologies. There were various options, and the technology from IBS was pretty mature, it was ready to be commercialized. However, from a prototype to a commercialized product, there is ways in between. But what we saw from our evaluation was that this is the biggest investment opportunity to go for.

IBS had been working on developing a commercial sequencing platform for some time. What aspects of the technology did you decide to change?

We needed to change pretty much everything. The basic concept was there. But we saw the chance to take this to a commercial product and we needed to get a lot of things into a commercial concept. You pretty much start from scratch with a concept in mind. A little bit of the architecture, the rotating platform with 20 flow cells, for instance, is the same. Everything else has changed — the chemistry has changed, the mechanics have changed, the flow path has changed.

What's your strategy for rolling out the GeneReader?

The timeline for the rollout is this year and next year. Phase 1 is identifying certain key players in the marketplace with a specific set of instruments and complete workflows. In phase 1a, we identify analytical challenges, in collaboration with certain institutes we have selected. And then, in phase 1b, we go into a very close relationship with a selected number of people, installing systems, the complete workflow, and identifying the routine work. And after that, in phase 2, we will have the retail launch of our instrument in the market, in Europe, North America, and Asia Pacific.

We are already working with early-access customers, clinical research labs who have alpha systems in their labs.

Where do you see advantages of the Gene Reader over sequencers that are already in the market? Illumina, for example, recently launched a CE-marked MiSeq sequencer with a cystic fibrosis assay. How will you compete with this and other systems?

It depends on where you are looking at it from. You can look at it from, 'Here is my specifications list,' and you compare apples to apples, and you might run into apples to pears. I think we can tie to what is expected by the marketplace. If you look for extraordinary read lengths, like 300 or 400 base pairs, maybe, maybe yes, is that relevant? When you look at the competitive landscape, like the CE-marked cystic fibrosis assay you mentioned, is that a challenge for us? Yes, it is, definitely. The competition should not be underestimated. I think this kind of competitive effort actually stimulates us, and stimulates the market as well. For us, it's the complete workflow, seamless, all the way down to data interpretation, and that will be one of the key differences to, let's say, an Illumina modular workflow.

Who do you see as prospective customers for the GeneReader system? Existing users of next-gen sequencing platforms, or new users?

Anybody who is in the next-gen sequencing arena, I believe, will be strongly interested in what we can provide. You will see people who are working on exome sequencing, whole genome sequencing, resequencing, and they will look at the bottleneck of throughput, the bottleneck of data interpretation, the bottleneck of front-loading. Is this the peak of the Gauss curve? I would say, no. And then you go into the Gauss curve, and our primary customers will probably be doing cohort studies, higher throughput, getting a crystal-clear understanding of more patients. And yes, we are going to see clinical research done in diagnostic laboratories, hospitals, et cetera. From the beginning, I would see that this is the picture of the Gauss curve. It might change to the right in three or four months, to go much more into clinical users. Why? Because the workflow seems to apply to those who love to do NGS on a routine basis, so there will be customers out there who have hesitated to do their own next-gen sequencing for now. And in the end, core facilities will also utilize our system. Why? Because of the workflow that allows them to offer their services as a more attractive product to the universities and the institutions.

You have already launched a number of next-gen sequencing gene panels in the area of cancer. What are your plans for developing additional panels?

We will start with cancer, we will expand into infectious diseases, and we are currently exploring our applied sciences market. We see a pretty good fit in all three markets we serve — the discovery translational market, the applied market, as well as our diagnostics market.

Do you have plans for developing regulated NGS-based diagnostic assays?

We are currently exploring that. There are too many open questions. There is ways ahead of us to launch the suite of products that we currently have in our plans. At the moment, we are scouting, we are searching, we are analyzing, we are in the middle of an assessment. There has to be clinical relevance, and at the same time, NGS is not yet a mature technology. So we have to first face the challenge, and I think Qiagen is the right company to do so, to bring together all the various components, the routine workflow, into a seamless scenario that makes routine work very feasible.

Do you think whole-genome and whole-exome sequencing will be important for translational research and clinical diagnostics?

For translational research, definitely. For clinical work, we will see. It very much depends on the maturity of the technology, how far you can strip it down and make it cheaper, cheaper, cheaper.

Is there anything else you would like to mention?

We have a particular focus on resequencing. We are not HiSeq-competitive, that's for sure. Is this a white spot on our agenda? The answer is, yes. Do we want to fill it someday? I hope so. But for now, we'll focus on executing our current initiative.

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