Navigation Links
Cepheid Collaborates With Pharmaceutical Leader on Chronic Myelogenous Leukemia

SUNNYVALE, Calif., Oct. 7 /PRNewswire/ -- Cepheid today announced an exclusive collaboration with Novartis for the commercialization of a test for monitoring the BCR-ABL gene transcript in peripheral blood specimens from patients diagnosed with Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). Together with other lab tests, monitoring levels of BCR-ABL transcripts in Ph+ CML patients will aid in patient management.

The collaboration reflects the commitment shared by Novartis and Cepheid to deliver the benefits of an FDA-cleared/approved molecular test that reports results which are linked to an internationally accepted standard called the "International Scale" (IS).  With the development of the class of drugs called tyrosine kinase inhibitors, Ph+ CML patients have access to the broadest range of therapeutic options ever available. A standardized molecular monitoring BCR-ABL test with greater reproducibility is expected to support optimal patient management decisions. By moving to a rigorously developed, regulatory-cleared/approved test which is also linked to the IS, the collaboration aims to reduce the variability that is currently inherent in BCR-ABL testing.

"Across the healthcare industry, focused diagnostic tests offer a very real opportunity for improved patient care and resource management through more directed treatment decisions," said John Bishop, Cepheid's Chief Executive Officer.  "With this in mind, Cepheid's collaboration with Novartis aims to deliver a standardized and accurate molecular test to support the management of CML patients."

Continued Bishop, "Cepheid's unique combination of accuracy, ease-of-use and reproducibility is unmatched in molecular diagnostics, and has established the GeneXpert® system as the leading molecular platform for healthcare associated infections.  Benefiting from Novartis' global reach and experience as the well respected leader in the treatment of CML, we look forward to extending the benefits of our best-in-class GeneXpert system to patients in the oncology field."

Xpert BCR-ABL has a CE Mark in Europe, and it has been available outside the United States since 2006.  Under the agreement announced today, the potential US commercialization of Xpert BCR-ABL will be accelerated, with Novartis funding the clinical studies and other development expenses.  Following the commercial release of the test, Novartis and Cepheid will explore further collaboration to develop other diagnostics which will help physicians better manage patient treatment.

In addition to funding development and clinical trial costs, Cepheid will receive an upfront fee of $5 million from Novartis with an additional $3 million in milestone payments over the next twelve months.  These monies will be recognized as 'Other Revenue,' ratably over approximately the next two years.  Upon commercial release in the US, Novartis will have exclusive global distribution rights to the Xpert BCR-ABL test under a Cepheid / Novartis label working in conjunction with Cepheid's Commercial Operations team.

About CepheidBased in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy to use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to access the full power of molecular diagnostics. The company's systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit

Forward-Looking StatementsThis press release contains forward-looking statements that are not purely historical regarding Cepheid's or its management's intentions, beliefs, expectations and strategies for the future, including those relating to product performance, timing of future product releases and future collaborations.  Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the company's current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: risks relating to the development process for new products, including unforeseen delays and costs; the ability to complete clinical trials successfully in a timely manner; uncertainties related to the regulatory processes; the performance and market acceptance of any new product; sufficient customer demand; the occurrence of unforeseen expenditures, acquisitions or other transactions; the impact of competitive products and pricing; and underlying market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K for 2009 and its most recent quarterly report on Form 10-Q, each filed with the Securities and Exchange Commission.

All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.CONTACTS:For Media Inquiries:For Cepheid Investor Inquiries:Jared Tipton

Cepheid Corporate Communications


Jacquie Ross

Cepheid Investor Relations


SOURCE Cepheid
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Cepheid Announces Termination of Contract With the Centers for Disease Control and Prevention to Develop Rapid Point of Care Test for Avian Influenza
2. Cepheid Launches New GeneXpert(R) Tests in Europe for Simultaneous, Rapid Detection of Staphylococcus Aureus and Methicillin Resistant Staphylococcus Aureus
3. Cepheid GeneXpert(R) System and Xpert(TM) MRSA Selected for up to 11 Victoria, Australia Hospitals in Rollout of Start Clean Strategy
4. Cepheid Announces CE IVD Release of First On-Demand Test for van A/van B Genes Most Associated With Hospital-Acquired VRE Infection
5. Cepheid Molecular Diagnostic Test for Positive Blood Culture Bottles Categorized Moderate Complexity by FDA
6. Cepheid Announces European Release of First On-Demand Molecular Test for Simultaneous Detection of Mycobacterium tuberculosis (TB) and Resistance to Rifampicin
7. Cepheid Receives Grant to Develop Ten-Color Real-Time PCR Detection Technology for Use in the GeneXpert(R) System
8. Cepheid Reports 2009 Third Quarter Results
9. Cepheid to Webcast Upcoming Financial Presentations
10. Advanced Life Sciences Collaborates with U.S. Government to Study Cethromycin as Treatment for Anthrax and Other High-Priority Biodefense Agents
11. Raydiance Collaborates With Rutgers University and Nations Largest Tissue Bank to Develop Innovative Tissue Processing Approaches
Post Your Comments:
(Date:11/26/2015)... 2015 ) ... "2016 Future Horizons and Growth Strategies in ... Supplier Shares, Country Segment Forecasts, Competitive Intelligence, ... --> ) has announced ... Horizons and Growth Strategies in the French ...
(Date:11/26/2015)... November 26, 2015 ... universitetssjukhus ser potential att använda SyMRI för ... för patienter med multipel skleros (MS) ... med SyntheticMR AB för att kunna använda ... sjukhuset. Med SyMRI kan man generera flera ...
(Date:11/26/2015)... , November 26, 2015 /PRNewswire/ ... --> adds "Global ... and "Investigation Report on China Repaglinide ... 2021 forecasts data and information to ... . --> ...
Breaking Medicine Technology:
(Date:11/26/2015)... ... ... Indosoft Inc., developer and distributor of the world-class Asterisk based contact center ... reliability. , The new Q-Suite 6 platform is based on the latest Java Enterprise ... a specific piece of software for many key components of the suite. Much of ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... has been recognized once again for its stellar workplace culture with the company’s ... , Medical Solutions’ Cincinnati office was named a finalist in Cincinnati ...
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... For the ... companies’ “ Two Organizations, One Beat ” campaign. The partnership between the two groups ... to aid in MAP International’s cause. , MAP International was founded in 1954 and ...
(Date:11/25/2015)... ... November 25, 2015 , ... Wimbledon Health Partners, the industry ... Wimbledon Athletics Facebook page to educate the public, parents and school athletic ... 2,000 people under the age of 25 die from sudden cardiac arrest every ...
(Date:11/25/2015)... ... November 25, 2015 , ... Beddit® has launched a new ... systems. The new app features a more intuitive SleepScore™ that rates sleep quality on ... slept. The SleepScore is created by a proprietary algorithm. Beddit analyzes the data to ...
Breaking Medicine News(10 mins):