NEW YORK (GenomeWeb) – Roche said today that sales for its Diagnostics division grew 7 percent in the first nine months of 2016, driven primarily by immunodiagnostic products.
In total, the Swiss pharmaceutical and diagnostics company booked CHF 37.51 billion ($38.03 billion) in sales for the first three quarters, a 6 percent increase over sales of CHF 35.53 billion during the same period in 2015. On a constant currency basis, sales grew 4 percent in the first nine months of 2016.
Roche Diagnostics sales added up to CHF 8.37 billion in the first three quarters of the year, up 7 percent from CHF 7.84 billion a year ago, both in local currency and at constant exchange rates. For the third quarter of 2016, diagnostics sales were CHF 2.8 billion, an 8 percent year-over-year increase at constant exchange rates.
Professional, molecular, and tissue diagnostics sales all continued to grow during the first nine months, while diabetes care sales still suffered from "challenging market conditions," especially in North America, the company said.
Professional diagnostics remained the largest contributor to diagnostics sales, accounting for 58 percent of the total. The business had CHF 4.88 billion in revenues during the first nine months, a 9 percent year-over-year increase both in local currency and at constant exchange rates.
Within professional diagnostics, immunodiagnostics sales grew by 14 percent during the first three quarters, and clinical chemistry sales increased 6 percent.
Roche pointed out that the new Cobas e 801 high-throughput immunodiagnostic module, which was launched in June in countries recognizing the CE mark and is part of the Cobas 8000 Analyzer, had "very good uptake." The company said it had delivered more than 100 instruments three months after the launch.
Diabetes care contributed 18 percent to overall diagnostics sales. Revenues for this business were CHF 1.48 billion during the first nine months, a 3 percent decline, or 2 percent at constant exchange rates. This shortfall was mainly due to "continued price pressure in the US," the company said.
Roche mentioned that it launched the Accu-Chek Guide in the European Union in August, a new blood glucose monitoring system for diabetes patients that provides advanced accuracy.
Molecular diagnostics accounted for 16 percent of diagnostics sales in the first three quarters, with CHF 1.35 billion, an 8 percent increase, and a 7 percent increase at constant exchange rates.
Roche said the main growth for molecular diagnostics came from the sequencing and molecular businesses. Within the molecular business, virology testing, which includes diagnosis and viral load testing of hepatitis and HIV as well as human papillomavirus (HPV) screening, grew 11 percent. HPV screening on its own grew 13 percent, and blood screening grew 3 percent.
The company pointed out that the FDA in August granted a premarket clearance and CLIA waiver for the Cobas Influenza A/B and RSV test, which runs on the molecular point-of-care Cobas Liat system. Besides influenza, the test identifies the respiratory syncytial virus (RSV), which causes more than 80 percent of acute lower respiratory tract infections in infants under one year of age.
Roche said it has plans to extend the test menu for the Cobas Liat in the areas of methicillin-resistant S. aureus (MRSA) and C. difficile detectionand has ramped up the manufacturing process for the system.
In addition, the FDA in August issued an emergency use authorization for the LightMix Zika rRT-PCR test, which runs on the LightCycler 480 or the Cobas z 480 system, for use in patients that meet clinical or epidemiological criteria developed by the US Centers for Disease Control and Prevention.
The tissue diagnostics business contributed 8 percent to diagnostics sales in the first nine months of 2016 with CHF 652 million, growing 15 percent over the year-ago period and 13 percent at constant exchange rates.
Within that business, sales in primary staining increased 18 percent and sales in the advanced staining portfolio grew 9 percent. Revenues from external personalized healthcare partnerships continued to grow strongly at 39 percent, the firm said.
Roche's Pharmaceuticals Division had CHF 29.14 billion in sales during the first nine months, up 5 percent, or 4 percent at current exchange rates, over last year's CHF 27.69 billion.
The company continues to expect overall sales to grow in the low- to mid-single digit percentage range at constant exchanges rates in 2016.