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Roche MDx Sales Grow 7 Percent in 2015

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

NEW YORK (GenomeWeb) – Roche today reported a 7 percent increase in molecular diagnostics sales for 2015, driven by its molecular and sequencing businesses.

Overall, the Swiss pharmaceutical and diagnostics company reported CHF 48.15 billion ($47.53 billion) in sales for the year, a one percent increase over the CHF 47.46 billion in sales for 2014. On a constant currency basis, sales grew 5 percent year over year.

Roche's Diagnostics division had sales of CHF 10.81 billion for the year, approximately flat compared to last year's CHF 10.77 billion. At constant exchange rates, diagnostic sales were up 6 percent, driven primarily by professional diagnostics and in particular immunodiagnostic products.

The company said it launched seven diagnostic tests and eight instruments in 2015, including the Cobas 6800 and Cobas 8800 systems for molecular diagnostics, and the Ventana HE 600 system for tissue diagnostics.

It also acquired four companies in 2015 — Ariosa Diagnostics, Signature Diagnostics, CAPP Medical, and Kapa Biosystems — that it said will complement its activities to build a next-generation sequencing portfolio.

Molecular diagnostics sales, which accounted for 16 percent of overall diagnostics sales in 2015, totaled CHF 1.72 billion for the year, up 7 percent over 2014 and 10 percent at constant exchange rates.

Roche said that major contributors to this growth were the molecular and sequencing businesses. The molecular business, in particular, was driven by 14 percent growth in virology, including 27 percent growth in HPV screening. This growth was supported by several tender contracts the company won in 2015, including the first national HPV primary screening tender in the Netherlands, and major blood screening tender contracts in Thailand, Germany, the UK, and Spain, which involve the Cobas 6800 and Cobas 8800 systems. The company also won competitive tender contracts in the UK, France, and Germany, involving tests that will also run on the Cobas systems.

Within the Diagnostics division, tissue diagnostics, which accounted for CHF 792 million or 7 percent of overall diagnostics sales in 2015, had the strongest growth for the year, at 11 percent, or 12 percent at constant exchange rates.

Professional diagnostics grew 2 percent for the year, or 8 percent at constant exchange rates, contributing CHF 6.18 billion in sales, or 57 percent of overall Diagnostics sales.

Diabetes care sales declined 11 percent in 2015, or 3 percent at current exchange rates, contributing CHF 2.13 billion, or 20 percent, to overall Diagnostics sales.

Among the Diagnostics division's planned instrument launches for 2016 is the Roche SMRT Sequencer, a single-molecule sequencer for clinical research the company is developing in collaboration with Pacific Biosciences and plans to commercialize worldwide this year.

Roche also plans to launch circulating tumor DNA oncology panels for cancer therapy selection in the US this year.

During an earnings presentation to investors in London today, which was webcast, Roland Diggelmann, COO of Roche Diagnostics, said that the company believes next-generation sequencing-based products will complement its existing business. "We are the leader in PCR, we have a very strong tissue franchise, and we think it's going to be complementary to that," he said. "This is one area where we indeed have invested significantly and are trying to build an end-to-end solution, as we know it in other areas of diagnostics."

But the company is also looking into other technologies for diagnostics, mainly in areas that are close to its existing business, Diggelmann said. "There are areas around automation and IT connectivity, there are technologies around microfluidics, there is robotics," he said.

In addition, he pointed out Roche's acquisition last year of microbial diagnostics firm GeneWeave, which "is really a novel way of looking into microbiology, and specifically into antibiotic susceptibility testing," he said. "We all know the resistance to antibiotics is a huge topic for healthcare systems, and increasing in importance." Roche said last August that it was planning to acquire GeneWeave for up to $425 million.

Roche's Pharmaceuticals division had CHF 37.33 billion in 2015 sales, up 2 percent, or 5 percent at current exchange rates, over 2014 sales of CHF 36.7 billion.

For 2016, Roche expects sales to grow at low- to mid-single digit percentage at constant exchange rates.