roche holding ag-genusschein (RHHVF) Snapshot

Roche won the FDA's blessing to market a hemoglobin-based diabetes diagnostic, the latest advance in testing for the disease and the first assay of its kind approved in the U.S. The Tina-quant HbA1cDx assay 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 allows physicians to better diagnose diabetes and plot its progression as they manage treatment for patients. The test works on Roche's Cobas Integra 800 platform, and the FDA's sign-off allows the company to start selling the test to clinical labs, making it first in line to cash in on U.S. demand for HbA1c testing. As the agency points out, there are tests FDA-cleared for diabetes monitoring, but Roche's offering is the first approved for diagnosis. The head start on sales of an in-demand test could well help Roche's flagging diabetes business. While the company's diagnostics arm hauled in $11.2 billion and a 20% share of the global diagnostics market in 2012, Roche has long struggled with pricing pressures and reimbursement cuts for diabetes.

Macrocyclics, Inc. announced new collaborative research agreement with Roche for the continued development of novel chelating agents designed specifically by Macrocyclics for Roche's applications. The new project will build on established expertise related to lead-212 (212Pb) and novel chelate architecture for radioimmunotherapy. The high level of synergy between the two organizations is expected to speed up the clinical development process.

Roche Presents at World Stem Cell & Regenerative Medicine Congress, May-22-2013 12:25 PM. Venue: Victoria Plaza, London, United Kingdom. Speakers: Matthias Steger, Global Head of Research and Technology Alliances.