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Roche Molecular Diagnostics Greg Heath on the AmpliChip and FDA

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AT A GLANCE

Greg Heath, senior vice president of clinical genomics of Roche Molecular Diagnostics

    Education
  • BS —1980, Psychology, Biology, Illinois State University, Normal, Ill.
  • MS — 1983, Psychology, Hollins College, Roanoke, Va.
  • PhD — Experimental Psychology, Virginia Commonwealth University, Richmond, Va.
  • Postdoctoral — Pharmacology, Toxicology, Michigan State; University of Cincinnati.

Greg Heath, senior vice president of clinical genomics at Roche Molecular Diagnostics, arrived in Pleasanton, Calif., two months ago to head the company’s clinical genomics unit, where he is responsible for the genomics and oncology areas of the company’s business, including implementation of Roche’s alliances with Affymetrix, DeCode, Epigenomics, and others.

Previously, he was head of business development and licensing for Roche Diagnostics, working in Basel, Switzerland, and reporting to Heino von Prondzynski, head of Roche Diagnostics worldwide. There his responsibilities included overseeing licensing, business development, the chief technology office, the venture office, e-business, and information business functions, as well as having responsibility for strategy development, including negotiating the 18-year, $70-million collaboration with Affymetrix.

The 45-year-old psychologist is now the company’s point person on the subject of diagnostics and microarrays and gave his first interview to BioArray News.

Why are you the one to discuss this?

I head the clinical genomics business at Roche Molecular Diagnostics. Roche has two divisions, pharmaceuticals and diagnostics. We sit in the diagnostics group. Diagnostics is organized into six global functions — I used to head one of those — five business areas and five geographic regions. The business areas generally make stuff, and the regions sell stuff.

I worked in business development and licensing, so I worked on the deal with Affymetrix. I came over to [Pleasanton] to basically do the implementation part of it. Clinical Genomics is comprised of a genomics unit that we have — we sell a cystic fibrosis product, for example — and the oncology group, which is mostly developing tests for oncology. We call it the ICCU, the Integrated Cancer Care Unit. So, we have grouped those two together and called it Clinical Genomics.

Can you bring me up to date on the discussions with the FDA?

We got a letter from the FDA back in July, around the 8th, basically suggesting that we come in and discuss with them why we think the AmpliChip CYP450 product should have ASR status. We had several conversations with them and we continue to have ongoing discussions. We have made our arguments for why we interpreted the regulations as allowing the product to fall under the ASR classification. And, they are thinking about it. So, that’s about where we are today. We are waiting for them to reply on that status. What we are doing in parallel is working on the IVD submission, which was the plan all along. Not too much news on that front.

What is Roche’s opinion on AmpliChips as ASRs?

Roche launched the AmpliChip CYP450 as an ASR based on its understanding of current FDA regulations. Since the product’s launch, we are very pleased to have the opportunity to work with the FDA to set appropriate regulatory guidelines for products in this new area.

What is your view of how the meetings have gone?

We talk to the FDA pretty regularly as we are the largest diagnostic company out there. So, we are always discussing with them either recommendations on different classifications, or opinions about how we can work together to get new technologies expedited through the system — while also ensuring that their mission of ensuring safety and efficacy is met. We tend to have an ongoing dialogue with them. This [microarray] was a newer technology that the FDA didn’t consider within the scope of the ASR regulations when they were first written. So, we didn’t view it as a real negative when this letter came, requesting discussion with them. I think it went as well as expected. I think they are feeling their way forward on how to classify these new technologies and we are working on how we can bring innovation to the market.

What does Roche think of microarrays in a world where the path leads down to pharmacogenomics and personalized medicine?

We certainly think that individualized medicine is going to happen. I don’t want to sound arrogant here, but I think between us and Affymetrix, if we can’t bring that to fruition, we don’t think there is much chance of that happening. We have a broad reach, and Affymetrix has some innovative technology there. It seems like a lot of people are coming around to a concept that’s been kicked around for some time. We think it will happen. Whether or not it will happen on a broad scale remains to be seen, but we are optimistic.

Is the microarray a key tool, a foundation, for that industry?

Microarrays could be. In its simplest form, if you think about it, something like blood screening or even immunoassay tests could be applied to the same concept. The thinking with a microarray is that it gives you the next level of complexity. We look at it as another platform for us. And, what I think Roche has excelled at is, really, the commercialization aspect. You know, PCR was invented within Cetus and Roche acquired Cetus. I think in this case, Affymetrix did the fundamental invention here, and Roche brings commercial strength to that. We have other platforms, and if one of the existing platforms is better suited to the customer needs, then, of course, we have access to that. If it requires a high-density array, we have access to that. I think for many of the genetic-level tests that are available today, you may not need a microarray. For what we expect to be available in the future, we think we do. That’s why we did the relationship with Affymetrix.

What impact do you think the conversation with the FDA will have on the AmpliChip?

A lot of our forecasts were built on the assumption that we would have an IVD product, and a CE mark for Europe, so I don’t know that there is any significant impact here. I think it’s possible that there may be upside, depending on how the FDA reacts to their regulations. If they assimilate this, it could open the door for similar technologies. But in terms of financial impact, we don’t anticipate any significant change there.

The IVAT document was written with a couple of other big players in the molecular diagnostics space. We have written about it, and have talked to some of the main authors. The collaboration among the competitors is of interest and speaks of the importance of the technology and the broad reach of it.

I probably wouldn’t want to comment on that. It’s outside the scope of my capabilities.

In terms of the product pipeline of AmpliChip tests, does this delay anything?

From the development side, we are continuing to work, and, depending on the FDA’s view, we may have to change our opinion a bit. But much of this stuff is relatively early stage, with regard to some of the marker discovery, and some of the fundamental technology issues that are still being worked out. But we are moving forward. It’s a fairly significant commitment on our end, if you look at the magnitude of the deal we made with Affymetrix. We are committed to going forward.

Roche lists CombiMatrix as an applied science partner, while Affymetrix is listed under diagnostic microarrays. What’s the difference?

If you look at the capabilities of the CombiMatrix array versus the Affymetrix array, the Affymetrix array, we felt, was more suited to consistent quality and manufacturability requirements that are necessary for producing an IVD product. They use fundamentally different technology for manufacturing. And, Affymetrix is really the only one producing product in mass quantity of consistent enough quality that we thought we could move it from research into the IVD status. CombiMatrix is our partner on the research end, which will enable researchers to do in situ hybridization. So, they will be able to create highly customized, lower-density experiments in their lab. It’s better suited, in our view, to the research market because it is completely customizable. Whereas, the Affy array, you can manufacture in scale. Affy’s customers tend to be, although they have aca-demic researchers, they tend to work a lot with pharma and biotech who have large-scale studies planned. So, that’s where we drew a distinction: to give a researcher full flexibility, we need something like the Combi platform. For consistent quality for IVDs, we need Affy.

Is the Affymetrix 11-micron format of any interest?

This has been their goal. They [Affymetrix] talk about Moore’s law and being able to increase the density on the chip. For us, what they have already is reasonable for many of the things we will want to achieve in the diagnostic realm. But, it certainly doesn’t hurt if we can do it on a smaller substrate. The more they advance the technology, the more we benefit. I think what they have today is pretty sufficient for diagnostic needs. If you have, for example, 500 mutations, you are probably pretty sick. You probably don’t need a microarray to tell you that.