NEW YORK (GenomeWeb) – Roche said today that its diagnostics division revenues grew 5 percent in the first nine months of 2017, driven by growth in immunodiagnostics and in the rest of its centralized and point-of-care solutions business.
For the nine months ended Sept. 30, the Basel, Switzerland-based pharmaceuticals and diagnostics firm's total revenues rose 5 percent to CHF 39.43 billion ($40.61 billion) from CHF 37.51 billion during the same period in 2016.
In the first nine months, Roche Diagnostics revenues were CHF 8.80 billion compared to CHF 8.37 billion a year ago, while its pharmaceuticals division revenues grew 5 percent to CHF 30.64 billion from CHF 29.14 billion last year.
Within the diagnostics division, Roche's centralized and point-of-care solutions business revenues grew 7 percent to CHF 5.21 billion from CHF 4.88 billion in the prior-year period. Its diabetes care business revenues fell 1 percent to CHF 1.46 billion from CHF 1.48 billion. Molecular diagnostics business revenues were up 3 percent to CHF 1.39 billion from CHF 1.35 billion. And the firm's tissue diagnostics business revenues rose 13 percent to CHF 735 million from CHF 652 million.
The diagnostics division achieved "very good performance in clinical diagnostics settings — including centeralized, molecular, and tissue combined" — which grew at 7 percent, Roche Diagnostics CEO Roland Diggelmann said on a conference call with analysts to discuss financial results.
He noted that the division experienced "good growth" and "a good geographic distribution" of its sales in almost all regions. One exception was North America, he said, where revenues grew only 1 percent and the firm has "seen some slowness … in clinical diagnostics in anticipation of PAMA and of the new clinical laboratory fee services which will take effect in January 2018."
He noted that the firm is seeing "some softness around laboratories' investments and capital goods purchased," and added that the company is studying the expected impact of the introduction of clinical laboratory fee services pricing. "Undoubtedly, this is driven by the [US Centers for Medicare and Medicaid Services] in the public sector and will also have some effect on the private sector," Diggelmann said.
Roche noted that in the first nine months of 2017, its centralized and point-of-care solutions business was the largest contributor to the division's sales growth, with continued strong sales growth in the Asia-Pacific region. Within that business, its integrated serum work area solutions, consisting of immunodiagnostics and clinical chemistry segments, were the primary drivers of growth. Year over year, immunodiagnostics product revenues rose 13 percent and clinical chemistry product revenues rose 3 percent.
Also residing within the centralized and point-of-care solutions business, the serology screening portfolio for Roche's cobas e 801 was completed. It enables laboratories to cover the full spectrum of serology testing on fully automated instrumentation, the firm said. Roche's Integrated Core Lab, of which the cobas e 801 is a key element, addresses the increasingly complex and challenging healthcare environment, Roche said, adding that more than 500 cobas e 801 modules have been placed in the market since its introduction. In June 2016, the firm launched the cobas e 801, a high-volume immunoassay test, in Europe.
Sales in Roche's molecular diagnostics business grew 4 percent growth in the underlying molecular business, offset by a decrease in the sequencing business. Regional growth in the segment was driven by Europe, Middle East, and Africa (EMEA) and Asia-Pacific region sales. Sales in the blood screening and HPV screening businesses grew 4 percent and 8 percent respectively. In virology, which includes Roche's portfolio for hepatitis B, hepatitis C, and HIV diagnosis and monitoring, sales declined 2 percent, reflecting a base effect of prior-year strong HCV sales.
In the firm's tissue diagnostics business, sales in the advanced staining and primary staining portfolios were up 10 percent and 13 percent respectively. Its companion diagnostics business grew 32 percent, Roche said. Revenues for its CINtec Histology and CINtec PLUS Cytology test rose 20 percent. In April, Roche received US Food and Drug Administration 510(k) clearance of CINtec Histology for cervical pre-cancer.
Revenues for Roche diabetes care decreased 2 percent and were affected by challenging market conditions, mainly in North America where revenues were down 11 percent year over year.
Roche said that in the first nine months of 2017, it launched the Navify Tumour Board solution, a clinical workflow and decision-support software that optimizes decision-making for cancer patient case reviews in the clinic, on tumor boards, or in multidisciplinary team meetings. The firm noted that it is the first product from Roche's Navify portfolio that provides healthcare professionals with digital decision support solutions "that transform patient care."
The firm said that the portfolio will evolve to include additional decision-support applications and workflow products that address challenges faced by healthcare providers.
The FDA recently approved the firm's cobas Zika test for use on cobas 6800/8800 systems. The firm said that it is the first commercially available test for detection of Zika virus RNA in samples of human plasma that's intended for use in screening blood donations.
For the third quarter of 2017, Roche Diagnostics reported that its revenues rose 6 percent to CHF 2.98 billion from CHF 2.80 billion in the prior-year quarter.
In 2017, Roche expects sales to grow in the mid-single digits at constant exchange rates. It expects that core earnings per share will grow broadly in line with sales also at constant exchange rates.