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Roche Reports 6 Percent Growth in Diagnostics in First Half of 2016

NEW YORK (GenomeWeb) – Roche reported on Thursday a 6 percent increase in revenues from its Diagnostics division for the first half of 2016, driven by strong growth of all diagnostics businesses except diabetes care.

In total, the Swiss pharmaceutical and diagnostics company reported CHF 25.02 billion ($25.5 billion) in half-year sales, a 6 percent increase compared to half-year sales of CHF 23.59 billion in 2015. On a constant currency basis, total sales grew 5 percent in the first half of 2016.

Roche Diagnostics sales totaled CHF 5.56 billion in the first half of this year, up 6 percent from CHF 5.24 billion a year ago, both in local currency and at constant exchange rates. For the second quarter of 2016, diagnostics sales were CHF 2.95 billion, an 8 percent increase at constant exchange rates.

Molecular diagnostics contributed 16 percent to half-year diagnostics sales, with CHF 903 million, a 9 percent year-over-year increase, and an 8 percent increase at constant exchange rates.

The main growth drivers for molecular diagnostics were the sequencing and molecular businesses, Roche said. Within the molecular business, virology testing grew 12 percent, which includes diagnosis and viral load testing of hepatitis and HIV, as well as human papillomavirus (HPV) screening, which on its own grew 16 percent.

In conjunction with molecular diagnostics results, the company pointed out a collaboration announced in April to increase access to testing and treatment for patients infected with the hepatitis C virus in six low- and middle-income countries.

Roche also noted the US Food and Drug Administration's approval last month of the Cobas EGFR Mutation Test v2 as a companion diagnostic for Tarceva in non-small cell lung cancer, which it said is the first FDA-approved assay for a liquid biopsy indication and can use both plasma and tumor tissue.

In addition, Roche mentioned that its LightMix Modular Zika Virus Assay became available in markets accepting the CE mark last month. The assay runs on the LightCycler 480 system and analyzes blood from patients with symptoms of Zika virus infection.

Professional diagnostics continued to be the largest contributor to diagnostics sales at 58 percent. The business had CHF 3.23 billion in revenues during the first six months, a 9 percent increase both in local currency and at constant exchange rates.

Within professional diagnostics, immunodiagnostics sales grew by 14 percent during the first half of the year, and clinical chemistry sales increased 6 percent.

In terms of recent product launches in professional diagnostics, Roche pointed out the CoaguChek INRange system, a home health device that controls coagulation status and monitors vitamin K antagonist therapy, which it introduced in May in countries accepting the CE mark. The company also mentioned the Cobas e801 module, a high-volume immunochemistry analyzer, which it launched last month in markets accepting the CE mark.

Roche's tissue diagnostics business  contributed 8 percent to diagnostics sales in the first half of 2016 with CHF 428 million in half-year revenues, growing 14 percent over the year-ago period and 12 percent at constant exchange rates.

Within that business, sales in primary staining grew 16 percent, driven by the automated Ventana HE 600 system for hematoxylin and eosin tissue staining that Roche launched in late 2015. Advanced staining portfolio sales grew 9 percent, and revenues from external personalized healthcare partnerships continued to grow strongly, at 29 percent.

Roche noted that the FDA in May approved the Ventana PD-L1 (SP142) test, which measures PD-L1 expression in patients with bladder cancer, as a complementary diagnostic test for Tecentriq treatment.

Diabetes care sales totaled CHF 998 million during the first six months, a 6 percent decline, and 4 percent at constant exchange rates. This shortfall was mainly due to "continued price pressure in the US," the company said.

Roche's Pharmaceuticals Division had CHF 19.46 billion in half-year sales, up 6 percent, or 4 percent at current exchange rates, over last year's 18.35 billion.

The company continues to expect revenues to increase in the low- to mid-single digit percentage range at constant exchanges rates in 2016.

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