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Roche Diagnostics Says HPV, MRSA Molecular Tests Will Help Drive Near-Term Growth

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The head of Roche Diagnostics today highlighted the company's PCR-based tests for human papillomavirus and methicillin-resistant Staphylococcus aureus as potential key drivers of expected continued growth in the coming year of the company's diagnostics business.

In a conference call to discuss Roche's second-quarter and half-year financial results, Roche Diagnostics Chief Operating Officer Daniel O'Day noted that Diagnostics continues to grow significantly above the market, and that the company expects to see a "significant improvement" in profitability for the business at the end of this year.

O'Day said that Roche Diagnostics ended 2009 logging 12.2 percent growth, and that the division has "very good first-half-year momentum" that will drive a significant increase by the end of 2010, as well.

Overall, Roche reported today that first-half 2010 sales for Diagnostics increased 7 percent to CHF5.25 billion (about $5 billion), with tissue diagnostics and applied science, which houses the company's PCR and sequencing products, providing the strongest growth at 13 percent and 11 percent, respectively.

And while molecular diagnostics contributed just 3 percent growth to the bottom line, O'Day specifically highlighted two product lines within that business unit — the Cobas 4800 HPV test and LightCycler MRSA Advanced Test — as two examples of "news flow in the first half of the year that … give you some idea of how we're going to drive continued sales in the future."

Specifically, earlier this month Roche released data from its "Addressing the Need for Advanced HPV Diagnostics," or ATHENA, trial in the US, which examined the Roche's Cobas 4800 HPV test to identify women with cervical pre-cancer missed by cytological examination with a Pap test (PCR Insider, 7/8/10).

The trial, which examined more than 47,000 women age 30 years and older, showed that one in 10 women who had a normal Pap test but who tested positive for HPV genotypes 16 and/or 18 with had cervical precancer lesions.

In its financial results presentation today, Roche said that the data supports the idea of the test as a "new standard" in HPV testing, while O'Day specifically said that "this is really game-changing data in HPV."

At the International Papillomavirus Conference in Montreal, where the data was "rolled out … to a group of more than 800 thought leaders and clinicians in the field of HPV … there was just tremendous response to this data," O'Day said.

"For the first time, in a prospective, randomized 47,000-woman trial, we've demonstrated that you are actually missing one in 10 women [with pre-cancerous lesions] if you just use Pap smear," O'Day said. "We've identified that you can go for your normal Pap test, and one out of 10 women will be missed in terms of high-grade pre-cancer cervical."

O'Day also said that HPV "is one of the most attractive markets in diagnostics," worth more than $3 million in the US alone and growing 20 percent annually. Roche Diagnostics will be competing for a piece of this pie in the short term with Qiagen's Digene HC2 HPV DNA Test.

"We knew that as a second entrant into this market, we had to have clearly differentiated advantages, and our trial has shown that we're at least as good on sensitivity and specificity as the assay on the marketplace now, the Digene assay," O'Day said.

According to Roche, its assay has a demonstrated sensitivity of 90 percent with 70.5 percent specificity, while the Qiagen assay has a sensitivity of 87.2 percent and specificity of 71.1 percent.

"Second, we've demonstrated significant clinical differentiated value of HPV 16 and 18," O'Day said. "And, we're the only test that, because of our workflow, allows you on one run with the sample to identify whether that sample is HPV 16 or 18 positive."

O'Day added that Roche Diagnostics "feels very confident as we prepare for the US launch of this product … and in talking with other countries around the world, that this data will be very compelling in terms of screening for HPV and cervical cancer incidence."

Roche launched the test with CE Mark in 2009, and is currently awaiting pre-market approval for IVD designation from the US Food and Drug Administration.

Another important driver of future growth will be the company's MRSA assay, which achieved FDA approval earlier this month, O'Day said (PCR Insider, 7/15/10).

"We now have an assay that is very competitive and … will go out there on one of the largest installed instrument [bases] in the US," O'Day said, referring to the LightCycler 2.0 PCR platform on which the test is run.

"In this environment, where hospitals are strapped for capital purchases, in some cases, they don't need to buy a new piece of equipment," he added. "Every hospital in the US has at least one LightCycler 2.0, and we're now launching a MRSA platform into what is a very attractive market in the US — more than $100 million, growing at a tremendous rate."

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