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Roche Execs Map Out Broad MDx Strategy at AACC Meeting

CHICAGO (GenomeWeb) — Roche Diagnostics this week provided a window into its business strategy, particularly in the area of molecular diagnostics where, over the last several months, the company has made a number of moves designed to position itself as "the most comprehensive provider of solutions in the molecular space," according to Roland Diggelmann, chief operating officer of Roche Diagnostics.

Speaking at the American Association for Clinical Chemistry annual meeting here this week, Diggelmann and Jack Phillips, president and CEO of Roche Diagnostics North America, highlighted the importance of Roche's molecular human papillomavirus recently receiving US Food and Drug Administration approval as a primary screening test for cervical cancer; the forthcoming launch of the firm’s ultra-high-throughput PCR-based testing systems; and its near- and long-term plans for the newly acquired Iquum point-of-care molecular testing platform.

In addition, Diggelmann and Phillips discussed the company's recent investments in nanopore sequencing technologies, and provided a snapshot of its broad companion diagnostic development strategy and efforts to grapple with the reams of data it anticipates generating with its bevy of molecular testing technologies.

Roche outlined its molecular diagnostics strategy in prepared remarks and a one-on-one interview with GenomeWeb Daily News at the AACC meeting, a week after it reported flat year-over-year first-half 2014 revenues for Roche Diagnostics and a 2 percent year-over-year drop for its molecular diagnostics business, both attributable primarily to currency effects.

However, at constant exchange rates, its diagnostics sales were up 6 percent while the MDx business was up 4 percent in 1H 2014. Coupled with the company's recent milestones and investments in the molecular space, this organic revenue growth is a cause for optimism in the division, Diggelmann noted.

The biggest highlight of the first half for Roche was approval by the FDA and Health Canada for the Roche cobas HPV test as a first-line screen for cervical cancer in women 25 and older. With the approvals in hand, Roche is now working closely with industry stakeholders, particularly professional organizations, to ensure that the test gets implemented in clinical practice.

"It starts with the FDA approval," Diggelmann said. "Without that there is no chance really of changing the guidelines. [Now] it's for the medical associations to … make recommendations … to all their members … that instead of doing an initial Pap smear, you should do a molecular test, our test."

This is not an overnight process, Diggelmann remarked, adding that "it's OK that it takes time because that means we're changing practice, how women are being diagnosed. But we are very confident that the changes will happen, because the data we present are so compelling … and the consequences are that cervical cancer detected early is curable; if detected late, it's a deadly disease. So there is a huge benefit here for the individual woman and the entire society."

Phillips added that Roche "could have launched this product way earlier and foregone a 47,000-patient clinical study, which cost a lot of money, and just entered early and gained market share. But we believe that we will make a long-term, meaningful impact on healthcare."

Increasing MDx throughput

Roche's HPV assay runs on the company's well-established cobas 4800 molecular testing system for medium-throughput, mid-volume clinical laboratories, and will continue to do so for the foreseeable future, Diggelmann said.

In the meantime, however, the company is gearing up for CE marking and European commercial launch later this year of the cobas 6800 and cobas 8800 — high- and ultra-high-throughput versions of the cobas 4800.

Specifically, Roche plans to launch both instruments in the EU with blood screening applications sometime in the current quarter, and with broad virology applications, such as HIV and hepatitis C, in the fourth quarter. The company is anticipating a US launch for the platform in 2016.

"The 4800 is the highest throughput that we have available until the launch of the 6800 and 8800," Diggelmann said. "I think technology has evolved, and more is possible today, so that's one element of it. But another is that we see further consolidation of the customer base, which means there will be more large labs with greater throughput needs and the same accuracy requirements. And that's a trend we have anticipated … to allow laboratories to remain very efficient."

In particular, Roche believes that the new instrument platforms will help it wrangle additional blood screening market share from what is essentially its only competitor, Grifols, which recently acquired Novartis' blood transfusion diagnostics business for approximately $1.68 billion.

"We have about a 50 percent market share. In simple terms, this is a market in the hands of two players … [because] there is such high demand on the accuracy, the quality, as safe blood is so important," Diggelmann said. "So the initial investments and entry into this business are just very large."

Typically the blood screening business is a "win-all, lose-all" situation, he added, and tender processes can span over many many years. "So you have a huge up-front investment, you need to do trials, you need to work with potential customers," Diggelmann said. "So these are multi-year programs, and we're confident that with this new system family, and with existing very strong assay performance, we'll do very well."

Point of care

Roche is not only addressing the high-throughput segment of the molecular testing marketplace, however, as earlier this year it also acquired Marlboro, Mass.-based Iquum and its Liat (laboratory-in-a-tube) system, a 510(k)-cleared and CE-marked point-of-care molecular testing system in a bid to quickly enter the near-patient MDx market.

With the acquisition, Roche also brought on board a Liat molecular assay for influenza A and B that is "ready to go" and will be for sale by the company this coming flu season, Diggelmann noted. "The ease of use and the quick turnaround time makes this so attractive, especially when diagnosing flu," he added.

In addition, the company currently is conducting clinical studies on Group A Streptococcus and respiratory syncytial virus assays, and is planning to expand the menu to include tests for methicillin-resistant Staphylococcus aureus and Clostridium difficile.

Looking further ahead, Roche believes the platform will be ideal for POC testing in resource-poor areas of the world, for diseases such as HIV. "We haven't disclosed a timeline … but it's definitely in our plans," Diggelmann said.

NGS revisited

Outside of the PCR realm, Roche recently reinvested in the next-generation sequencing space with its June acquisition of nanopore sequencing firm Genia Technologies and a strategic investment in nanopore sequencing startup Stratos Genomics. These moves followed news in October that Roche would be closing down its 454 Life Sciences sequencing operations by 2016.

One of the most attractive features of these new nanopore-based sequencing technologies, particularly for clinical applications, is their ability to enable single-molecule sequencing.

"It allows for real time, and using nanopores will also mean that … we'll move into electrical detection,” versus the standard today of optical detection, Diggelmann said. "That means you won't need the amplification, you won't need to have the start/stop of the run, but you can just go right away, and hopefully be able to do longer reads. That, coupled with the higher throughput and short turnaround time, will then drive down the cost of sequencing."

He added that Roche still believes that 454 is a "great technology if you want to do very targeted sequencing ... but it doesn't have the broad applications. I think it just shows that sequencing is a technology like many others where the initial S curve … is very short, and next generations supercede the old generation fairly quickly because it's young technology."

Diggelmann warned, however, that it will likely be several years before its recent sequencing investments will be translated into a commercial product, and that Roche considers it to be a "high-risk" endeavor. "It may not work, but if it does work, we think it has a lot of potential," Diggelmann said. "The risk is that there is attrition, but we like it for its potential disruptive nature."

CDx and 'big data'

Broadly speaking, all of Roche's molecular investments, as well as its well-established tissue diagnostics business, will support the company's efforts in the companion diagnostic and personalized medicine space, an area that Roche believes is a cornerstone of future growth.

"We've always maintained that we have a core strategy, which is personalized healthcare, where we really want to leverage the capabilities of both [Roche] Pharma and Diagnostics," Diggelmann said. "We believe this is the future. By the same token, we also believe it can't be only us working internally. We want to work and be a partner of choice for external pharma, as well."

To that end, the company has in place some 40 collaborations with other pharmaceutical companies in the area of companion diagnostics, the most recent of which is an agreement announced this week with AstraZeneca to develop a CDx for AstaZeneca's investigational compound for non-small cell lung cancer.

That test will likely be based on PCR technology, Diggelmann said, and will be developed to identify epidermal growth factor receptor mutations in tumor tissue and plasma samples from patients with NSCLC. However, Roche plans to leverage all of its technology capabilities to achieve its CDx development and partnering goals.

"It's not as important which [technology] gives you the result and allows you to validate the biomarker hypothesis," Diggelmann said. "The majority of it will be tissue-based, and of course we have the molecular PCR-based, but we [are also developing] some other blood-based tests. So it's literally across our entire technology bank."

Finally, Diggelmann and Phillips noted that the company has recently begun eyeing strategies to tackle so-called "big data," of which Roche anticipates generating plenty, considering its wide array of diagnostic initiatives.

"[Information technology] is such an important part of diagnostics," Diggelman said. "Of course you generate data, and it's how you feed back data, how you actually make it actionable, that's really critical. So I think it's core to what we do. Now the question is, can we do more with that, and with generating so much data, are there partners we can work with?"

To that end the company is actively working with partners "where we can actually exchange and leverage that information to ultimately lead either to greater transparency, feed that information back into R&D, or literally just build a model around the data that we generate. There are models that you can think of in the future where this could be generated together with many different stakeholders … [such as] payors, healthcare systems, patients."

Phillips noted during his presentation that Roche currently has a "few pilot projects" in place in this area, but declined to provide additional information on these efforts.

"I would add that … having Roche Diagnostics and pharma under one roof … gives us a completely new angle on this," Diggelmann said. "Real patient data, for instance, or the ability to generate clinical trial data, et cetera. This is going to be an interesting approach."