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Roche's Molecular Dx Sales Grow 7 Percent in First Nine Months of 2015

This article has been updated with information from Roche's earnings call.

NEW YORK (GenomeWeb) – Roche today reported a 7 percent increase in molecular diagnostics sales for the first nine months of 2015, driven by virology testing, HPV screening, and noninvasive prenatal testing.

Overall, the company booked CHF 35.53 billion ($36.57 billion) in sales for the period, a two percent increase over the CHF 34.76 billion in sales for the same period last year.

The diagnostics division had sales of CHF 7.84 billion for the first three quarters, up 1 percent over last year's CHF 7.79 billion. At constant exchange rates, diagnostics sales were up 6 percent, and the division continues to see "very good momentum," Roland Diggelmann, COO of Roche Diagnostics, said in a conference call to discuss the earnings.

Molecular diagnostics sales, which accounted for 16 percent of all diagnostics sales, grew 7 percent to CHF 1.25 billion. At constant exchange rates, the increase was 10 percent.

Roche said major contributions to sales growth in molecular diagnostics came from virology testing, which increased 13 percent, and HPV screening, which grew 24 percent. Another growth driver was the sequencing business, in particular Ariosa Diagnostics' noninvasive prenatal Harmony test.

The company recently launched the Cobas EGFR Mutation Test v2, its first liquid biopsy PCR test, in Europe. The test, which identifies 42 mutations in EGFR from plasma and is used to select patients with non-small cell lung cancer for treatment with an EGFR tyrosine kinase inhibitor, received CE marking last month and is commercially available in several countries recognizing the CE mark now.

Diggelmann said Roche is the only company that offers a liquid biopsy and a tissue test for EGFR mutations. The plasma test, he said, will be especially important for patients where no biopsy can be taken or where the available tissue is inadequate or not enough for testing.

Roche is also looking forward to using the liquid biopsy test to monitor for drug resistance and to improve patient management, he said, noting that clinical progression can often be seen "much earlier" than with conventional imaging technologies.

The company also recently received a CLIA waiver from the US Food and Drug Administration for its Cobas Influenza A/B test, which runs on the Cobas Liat system, a point-of-care real-time PCR system that enables tests to be used in non-traditional settings such as doctors' offices, emergency rooms, and retail pharmacies.

In the Netherlands, Roche won a five-year contract from the National Institute for Public Health and the Environment to implement the Cobas HPV test as a first-line primary screening test in the country's national cervical cancer screening program. "With that, I think we will continue to see more HPV growth and we are also able to introduce, literally, a new standard of testing in HPV," Diggelmann said.

The company also recently received approval from the US FDA for the Cobas 6800/8800 PCR platforms and associated hepatitis B and C viral load assays.

Among its diagnostics businesses, Roche saw the strongest growth in tissue diagnostics, which grew 11 percent in sales for the period, to CHF 567 million, driven by immunohistochemistry. Tissue diagnostics accounted for 7 percent of overall diagnostics sales.

Professional diagnostics, which contributed 57 percent to overall diagnostics sales, grew 2 percent, to CHF 4.49 billion, based on 12 percent growth in immunoassays, which Diggelman said have applications across many disease areas, such as oncology, cardiology, and virology. Diabetes care, which made up 20 percent of diagnostics sales, declined 11 percent, to CHF 1.53 billion.

Roche's pharmaceuticals division booked CHF 27.69 billion in sales, an increase of 3 percent (6 percent at current exchange rates) over CHF 26.97 billion during the first nine months of 2014.

Based on its strong performance in the first three quarters of 2015, Roche raised its guidance and now expects sales for the year to grow in the mid-single digit range at constant exchange rates, instead of in the low- to mid-single digit range that it previously estimated.