Roche Diagnostics Corporation relies on science, not stars, to make its predictions. The US arm of Roche's global diagnostics division, the firm makes and sells a variety of products for consumers, researchers, and health care providers. Its Roche Professional Diagnostics unit offers analytical systems for clinical labs, including assays and reagents; it also sells point-of-care tests used in doctor's offices and ambulances. The Accu-Chek product line is held by the Roche Diabetes Care division and includes glucose monitors and condition management systems. Other operations include Roche Molecular Diagnostics (DNA analysis), Roche Tissue Diagnostics (cancer), and Roche Applied Science (gene sequencing).
Roche Diagnostic's main Indianapolis location is the North American headquarters for Roche's diagnostic operations. The company has other locations in Arizona, California, Connecticut, New Jersey, and Wisconsin, as well as Puerto Rico and Canada. Swiss parent Roche Holding has additional diagnostic subsidiaries scattered around the globe, with a majority of sales being conducted in Europe and North America.
The company is the world leader in in vitro diagnostics; products used to test blood and other body fluids and tissue samples to obtain information for the diagnosis, treatment and monitoring of diseases. Its product portfolio ranges from blood glucose meters for people with diabetes and point-of-care testing devices for use in doctors’ offices, to high-throughput analyzers for hospitals and commercial diagnostic laboratories.
Sales and Marketing
Roche Diagnostics does its business through a supplier portal and e-Commerce. Its US national wholesale distributors are AmerisourceBergen, McKesson, and Cardinal Health.
The Diagnostics division accounted for 23% of Roche Holding's revenues. Overall, North America provides 40% of the parent company's revenues.
Roche Holdings has expanded Roche Professional Diagnostics -- the largest diagnostics division -- through acquisitions. Headquartered in Switzerland, the Professional Diagnostics division conducts internal R&D efforts that result in regular upgrade launches for existing equipment, as well as the development of new testing assays for additional health conditions.
Roche Diagnostics is also expanding its second largest division, Germany-based Roche Diabetes Care, which makes insulin delivery pumps and diabetes diagnostics and monitoring products. The unit regularly seeks to better serve its customers by expanding its product offerings and improving its products' accuracy and usability.
In the high-growth field of gene-based testing, Roche Molecular Diagnostics (which has its global headquarters in California) develops a variety of screening tools such as blood supply screening kits and HIV and hepatitis tests based on DNA analysis. The unit is also focused on developing and commercializing companion (or personalized) diagnostic products, which help doctors determine how a patient's genetic make-up will affect how that person will respond to drugs or other forms of treatment. The division is a leader in the molecular diagnostics field and has launched a broad line of DNA-based tests for disease detection and companion diagnostic purposes.
The Roche Tissue Diagnostics, which is primarily made up of Arizona-based subsidiary Ventana Medical Systems, develops systems that analyze human tissue for the diagnosis of cancers and other diseases. The Tissue Diagnostics unit is working to expand its offering of diagnostic probes; it is also working to develop companion diagnostic tests. In addition to growth through acquisitions, Ventana launches new product offerings through internal R&D efforts and partnerships.
In 2015 the global diagnostics division was investing 450 million Swiss francs (over three years) in a new diagnostic manufacturing facility in China.
In 2015 the FDA granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the company's cobas Strep A test for use on the cobas Liat System. It also provided 510(k) clearance for the cobas HSV 1 and 2 Test for the direct detection and differentiation of HSV-1 and HSV-2 DNA in anogenital specimens from symptomatic patients.