|2013 med tech R&D budget:||$1.14 billion|
|Change from 2012 budget ($1.06 billion):||
|Percent of segment sales ($11.73 billion):||9.7%|
Roche ($RHHBY) is one of the only pharma giants with a large standalone diagnostics division, which incorporates its molecular diagnostics, analytics instruments and diabetes care devices. Roche Diagnostics launched 11 new products in 2013, according to the annual report. Key products included new blood glucose meters, the cobas 4800 EGFR test for non-small cell lung cancer stratification and the Confirm in vitro diagnostic for breast cancer.
The most significant new development so far in 2014 is FDA approval of an expanded indication for the cobas HPV Test to include first-line primary screening for cervical cancer. On a related note, Roche launched the CINtec PLUS cytology test to detect precancerous cervical disease worldwide (not including the U.S.) in February.
In addition, Roche plans on obtaining CE marks for its cobas 6800 and 8800 molecular diagnosis platforms later this year, and hopes to have blood-screening tests ready to roll for each new system by midyear and virology assay launches by the end of 2014, Paul Brown, president of Roche Molecular Diagnostics, told FierceDiagnostics in 2013. A Japanese launch is also planned for this year.
The annual report lists only one new product launch in the U.S. compared to 10 in the European Union and four global launches not including the U.S., a reflection of the strict FDA approval requirements. Still, Roche is partnering with the U.S. National Institutes of Health on a diagnostic for managing heart failure, though the clinical trial isn't scheduled to conclude until the end of 2016.
Several Big Pharma have sold off noncore units in 2014 as they seek to focus on core competencies. But diagnostics is critical to Roche and won't be affected by that trend. In fact, Roche acquired molecular diagnostics company IQuum in February and next-generation sequencing company Genia Technologies in June.
Roche diagnostics accounted for 11.7% of the company's R&D budget. But there's a payoff for Roche's core pharma unit too. The company said in its annual report that two-thirds of its late-stage drug candidates are being developed with a companion diagnostic.
Finally, third-party researchers may now have easier access to Roche's clinical trial data under a new data-sharing policy, according to the annual report: "Under the new policy we are providing access to global clinical study reports on request, and from 1 January 2014, researchers will also receive access to patient level data from our global clinical trials after their requests have been reviewed by an independent panel of experts." -- Varun Saxena (email | Twitter)
- here's Roche's 2013 annual report
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