Media Release

Basel, 23 January 2017

Roche enters a new era in haematology testing, with the launch of the new cobas m 511 analyser

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its new, dedicated haematology testing solution, the cobas m 511 integrated haematology analyser, is now available for countries accepting the CE Mark*. This launch marks the entry for Roche Diagnostics in the haematology market, with a Roche developed system.

Currently, haematology testing requires a larger blood sample from a given patient, which needs to be run across several different systems in order to get the full set of results. This is labour- and time-intensive, and potentially provides inconsistent results, as slide images are difficult to interpret.

Featuring Bloodhound® technology, the cobas m 511 addresses the challenges of haematology testing by combining the three components of the process: a digital morphology analyser, cell counter and classifier into one streamlined solution which prepares, stains and analyses microscopy blood slides.

 “With this launch, patients will benefit from a faster and more accurate diagnosis of blood diseases, as diverse as anemia and leukemia”, said Roland Diggelmann, CEO of Roche Diagnostics. “We are entering a new area of innovation with Roche in haematology testing, supporting customers with integrated and efficient laboratory solutions, which deliver increased medical value”.

The cobas m 511 provides greater accuracy and consistency of results, compared to current technologies, by identifying, counting, isolating and categorising white blood cells, red blood cells and platelets, then presenting the digital images of all these cell types. Medical technologists can now concentrate their time on finding and classifying abnormal cells within patient samples. This automation and digitalization reduces the need for resource-intensive manual microscope reviews, supports clinicians to share challenging cases around the world and enables the delivery of quicker results, which ultimately aid patient diagnoses.

About Haematology

There are more than 150 identified haematology related diseases, also called blood diseases, blood disorders or haematological disorders. They can be either benign (noncancerous) or malignant (cancerous) and are broadly classified according to the different components of the blood that are affected: red blood cells, white blood cells, platelets and blood plasma.

The burden of blood disorders is very high, not only for patients but for society as a whole. Recent studies estimated that, in Europe, 80 million people suffer from haematological disorders and the economic impact of blood disorders in Europe amounts to EUR  23 billion per year, mostly in healthcare expenditure. Improved diagnosis is a key factor to counteract the rise on this economic burden for healthcare and society.1

About the cobas m 511 and Bloodhound® technology

The cobas m 511, uses a unique approach to enter the new field of digital haematology through patented Bloodhound® technology for printing, staining and imaging. This technology uses only 30µL of blood to print a monolayer onto the slide, stains with an improved method for further analysis of the morphology and enables classification of cells displayed on a Viewing Station.

Contrary to the commonly used indirect methods in blood analysis today - primarily impedance and flow cytometry - the cobas m 511 images individual cells directly. Based on these direct images, the Bloodhound® technology counts, analyses morphology and then classifies every cell in the viewing area to provide a standard complete blood count (CBC) and 5-part differential and reticulocyte count. While haematologists will continue to have the option of looking at slides under their microscopes; the cobas m 511 provides cell-by-cell images that, in many cases, may eliminate the need for microscopic review.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices.

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

*Local product availability may vary independently from CE Mark approval. The cobas m 511 integrated hematology analyser is not available in countries with previously agreed 3rd party vendor agreements.

References

1. Green T, Bron D, Chomienne C, Duyvené de Wit T, de Haas F, Engert A, Hagenbeek A, Jäger U, MacIntyre E, Muckenthaler M, Smand C, Sonneveld P. Costs of haematological disease high and rising. Lancet Haematol 2016 http://press.thelancet.com/HaemComments.pdf