Roche ($RHHBY) previewed part of its future this summer, debuting one of two new molecular diagnostics platforms at industry conferences in Italy and The Netherlands. Now, the Swiss giant is in the early stages of prepping for a launch next year in Europe and Japan of both systems--cobas 6800 and cobas 8800.
Roche is already ahead in the industry, commanding about a third of the more than $3.6 billion global molecular diagnostics market. But without updating and releasing new products, market domination can easily crumble. That means for both the cobas 6800 and cobas 8800, the stakes are pretty high, Paul Brown, president of Roche Molecular Diagnostics, explained in an interview with FierceDiagnostics.
"They are key," Brown said. "They are very important for us as we move forward. They are instruments that will service labs that have significant throughput demand ... [and] will replace the instruments that today are running on the majority of our blood screening and virology assays."
Brown said his division's future essentially depends on both products.
"They will ultimately replace a significant portion of our total revenues," he said.
Brown described both the 6800 and 8800 as workhorse platforms. The cobas 6800--the smaller of the two--will be able to process 300 samples for diagnosis in an 8-hour shift. The cobas 8800, on the other hand, is designed to handle 1,000 over the same time period.
Brown said the tests will "change the way molecular diagnostics is run" by consolidating assays onto a single platform, improving both workflow and efficiency. The broader molecular diagnostics industry has been looking to move in this direction, along with a separate consolidation of testing labs into lager facilities. And so Roche moves beyond hyperbole in making assertions about both products because its sheer size and market research could make a difference when the cobas 6800 and cobas 8800 come to market.
The hope is to obtain a CE Mark for both the cobas 6800 and cobas 8800 in 2014, and a Japanese launch will also come next year. Roche is pushing to have blood-screening tests ready to roll for each new system by mid-year and virology assay launches by the end of 2014.
Brown explained that U.S. clinical trials are further in the future, though the company will be seeking PMA status for both products because each represents "a completely new platform in molecular diagnostics."