|Roche's next-generation diabetes diagnostic works on the Cobas Integra 800 analyzer. --Courtesy of Roche|
Roche Diagnostics ($RHHBY) is kicking off the marketing of its FDA-approved Tina-quant HbA1cDx assay, a hemoglobin-based diabetes diagnostic the company says can identify the disease and guide treatment before the onset of late complications.
The test, which works on Roche's Cobas Integra 800 platform, charts a patient's average blood sugar levels over the past three months by measuring the percentage of hemoglobin A1c bound to glucose. That information helps physicians more easily spot undiagnosed diabetics and ensure they get proper treatment, all with a lab test that doesn't require patients to be in a fasted state, Roche Professional Diagnostics Vice President Randy Pritchard said.
"In addition, they benefit from easily indexing a patient's hemoglobin glycation in real time, without time-consuming and staff-intensive post-analytical steps," Pritchard said in a statement. "This improves clinical workflows, saves time and even costs, representing a step forward in the management of diabetes mellitus."
Roche won FDA approval for HbA1cDx in the spring, and getting it on shelves worldwide gives the company a leg up on rival Abbott Laboratories ($ABT), which won a CE mark earlier this month for an A1c test of its own. Abbott has filed for FDA approval for its test and is in the meantime rolling it out in countries across Europe, Asia, Latin America and Africa.
The head start on sales of an in-demand test could well help Roche's flagging diabetes business. In October, Roche announced plans to cut 100 jobs in diabetes and shift the business' diagnostics division to its Indianapolis headquarters while moving the glucose monitor unit to Germany. Now, according to a Reuters report, Roche is exploring the idea of unloading the meter business, meeting with potential suitors in early-stage talks.
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