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Roche Reports 4 Percent Growth in Diagnostics for Q1

NEW YORK (GenomeWeb) – Roche on Tuesday reported a 4 percent increase in diagnostics sales for the first quarter of 2016, spurred by growth in three of its four diagnostics businesses.

Overall, the Swiss pharmaceutical and diagnostics company reported CHF 12.41 billion ($12.92 billion) in quarterly sales, a 5 percent increase over last year, when sales totaled CHF 11.83 billion. On a constant currency basis, Roche's sales grew 4 percent in the first quarter.

Sales for Roche Diagnostics amounted to CHF 2.61 billion in the first quarter, up from CHF 2.51 billion a year ago. At constant exchange rates, diagnostics sales grew 5 percent. The firm saw "strong growth" in its immunodiagnostic, molecular, and tissue diagnostic businesses, while sales in diabetes care were "impacted by challenging market conditions, especially in North America," Roche said in a statement.

The molecular diagnostics business, which contributed 17 percent to overall diagnostics sales, took in CHF 446 million in revenues during the first quarter, a year-over-year increase of 11 percent, both in local currency and at constant exchange rates.

Contributors to the growth in molecular diagnostics were sequencing and virology testing. The firm noted a 16 percent increase in virology testing, which includes diagnosis and monitoring of hepatitis and of HIV viral load, as well as human papillomavirus (HPV) screening, which by itself grew 16 percent.

Hepatitis testing alone accounts for about 60 percent of Roche's infectious disease and virology portfolio, the firm said, and within that, serology-based hepatitis testing grew 5 percent during the quarter, and molecular or PCR-based hepatitis testing 11 percent. 

Roche said virology testing benefited overall from instruments and tests it launched in 2015, and from several tender contracts it won last year.

The company noted the US Food and Drug Administration's decision last month to allow the use of the Cobas Zika assay under an investigational new drug application to screen blood donations for the Zika virus in areas with active mosquito-borne transmission. This approval allows the company to recover its costs but does not permit commercial sales, Roche said. Zika testing is currently performed in Puerto Rico and is expected to expand to centers in the southern US.

In addition, Roche said, the FDA granted emergency use authorization for the LightMix Zika Virus rRT-PCR test, which is CE marked and available globally outside the US.

Roche's professional diagnostics business continued to contribute the lion's share to diagnostics revenue — 58 percent during the first quarter. Sales for that business totaled CHF 1.52 billion, a 7 percent increase over last year's first quarter, both in local currency and at constant exchange rates.

Growth in professional diagnostics was driven by immunodiagnostics, which increased 12 percent during the quarter, while clinical chemistry sales increased 6 percent.

Roche pointed out a study in the New England Journal of Medicine earlier this year on the prognostic value of its Elecsys sFlt-1/PlGF immunoassay ratio test for predicting preeclampsia risk in pregnant women, and another study, published this year in the Annals of Emergency Medicine, on its cardiac troponin T test that provides a more rapid diagnosis of heart attack for patients with acute chest pain.

The tissue diagnostics business, which made up 8 percent of diagnostics sales in the first quarter, had CHF 206 million in revenues and grew 16 percent over the year-ago period, and 13 percent at constant exchange rates.

Within that business, sales in primary staining increased 24 percent, while advanced staining portfolio sales grew 10 percent. Roche said growth was fueled by the fully automated Ventana HE 600 system for hematoxylin and eosin tissue staining it launched late last year. In addition, revenues from external personalized healthcare partnerships "showed continued strong growth."

Diabetes care, which contributed 17 percent of first quarter diagnostics sales, amounted to CHF 443 million, a 13 percent decline, or 11 percent at constant exchange rates. This decline was mainly due to "a continued spillover of Medicare prices to commercial plans" for blood glucose monitoring products in the US, resulting in a 49 percent decline in sales in North America.

Roche's Pharmaceuticals division booked CHF 9.8 billion in first quarter sales, up 5 percent, or 4 percent at current exchange rates, over last year's first quarter sales of 9.32 billion.

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