NEW YORK (GenomeWeb) – Roche today reported a 9 percent year-over-year increase in sales for molecular diagnostics in the first half of 2015, driven by strong growth in its underlying molecular businesses and its sequencing products sales.
The Swiss pharma and diagnostics firm reported overall sales of CHF 23.59 billion ($24.63 billion) for the period, a 3 percent increase over sales of CHF 22.98 billion reported for the first half of 2014. Revenues increased 6 percent at constant exchange rates.
Roche's diagnostics division had CHF 5.24 billion in sales, up 2 percent from CHF 5.14 billion during the first half of last year. At constant exchange rates, sales for diagnostics were up 7 percent.
Sales for molecular diagnostics totaled CHF 832 million for the first half of 2015, up 9 percent over the same period last year, and 12 percent at current exchange rates. The firm cited major contributions from virology testing and HPV screening.
Roche launched two CE-marked tests during the last six months, the cobas DPX test for parvovirus B19 and hepatitis A virus and the cobas HBV quantitative nucleic acid test. Both tests run on the cobas 6800/8800 automated real-time PCR systems, which Roche launched last year.
It also obtained clearances from US health authorities for the cobas HSV1 and 2 test, the next-generation cobas MRSA/SA test, the cobas Cdiff test, as well as approval for the cobas KRAS mutation test for use on the cobas 4800 system.
In addition, US authorities granted a CLIA waiver for the cobas Liat system, a point-of-care molecular instrument, in conjunction with the cobas Strep A test. The test, which uses throat swabs, is the first CLIA-waived PCR test to detect Streptococcus pyogenes. Roche said that the CLIA waiver allows for the test to be used by healthcare providers at non-traditional laboratory sites.
According to a company presentation for investors, Roche has also submitted its Influenza A/B test for the Liat Analyzer for a CLIA waiver and plans to add new tests for the platform, in particular RSV tests and an MRSA and C. difficile test. It estimates the size of the target market for Liat tests to be CHF 350 million.
Roche's non-invasive prenatal Harmony test drove growth in the sequencing business. The company obtained the test through its acquisition of Ariosa Diagnostics last year.
Later this year, Roche plans to launch the cobas 6800/8000 systems and the cobas MPX multiplex blood screening test that runs on it, as well as the Influenza A/B and RSV test, which runs on the cobas Liat, in the US. It also plans to launch the HIV-1, HCV, and HBV tests, which run on the cobas 4800, as well as the cobas EGFR test V2 in the EU.
Sales for Roche's professional diagnostics unit totaled CHF 2.97 billion year over year, up 2 percent. For diabetes care, sales were down 7 percent to CHF 1.06 billion; and for tissue diagnostics, sales were up 12 percent to $374 million.
Roche's pharmaceuticals division booked CHF 18.35 billion in sales, up 3 percent from 17.83 billion during the same period in 2014, and up 5 percent at constant exchange rates.
The company said it expects 2015 sales to grow in the low- to mid-single digit range at constant exchange rates.