Latest Roche Molecular Diagnostics Stories
CAMBRIDGE, Mass., Jan. 7, 2013 /PRNewswire/ -- Epizyme, Inc., a biopharmaceutical company leading the creation of personalized therapeutics to treat patients with genetically defined cancers, Eisai Co., Ltd. (ESALY) and Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today a collaboration to develop an in vitro PCR (Polymerase Chain Reaction) based companion diagnostic test. The collaboration's goal is to identify lymphoma patients with non-wild type EZH2, including the Y641 mutation....
PLEASANTON, Calif., July 5, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for a new test to assess a patient's viral load of cytomegalovirus (CMV). The fully automated COBAS® AmpliPrep / COBAS® TaqMan® CMV Test is the first FDA-approved laboratory test for use in quantifying CMV DNA in human plasma specimens. Physicians use CMV DNA viral load information from...
PLEASANTON, Calif., July 2, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that a new HIV viral load test has been approved by the United States Food and Drug Administration (FDA) and will be commercially available in the US later this year. Like other innovative Roche HIV tests, this one targets two highly conserved regions of the HIV-1 genome and avoids any regions which are current drug targets, thus providing increased reliability as compared to other...
PLEASANTON, Calif., March 30, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the FDA approval of a new pre-analytical instrument that provides an integrated primary tube handling solution for its widely adopted automated molecular testing platform. The cobas p 630 Instrument, being introduced with new AMPLILINK 3.3 series software, unites primary tube handling with fully automated sample preparation, amplification and detection for molecular diagnostics on...
PLEASANTON, Calif., Feb. 22, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) and Life Technologies Corporation (LTC) announced today that they have entered into two license agreements to allow LTC to expand its PCR offerings for diagnostics applications. Under these two agreements, Roche has granted LTC an in vitro diagnostics product license to all of Roche's patents for real-time PCR (polymerase chain reaction) as well as other important PCR-related technology in the...
PLEASANTON, Calif., Feb. 1, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has provided 510(k) clearance to the cobas® CT/NG Test for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections in both symptomatic and asymptomatic patients from male urine and self -collected vaginal swabs. A polymerase chain reaction (PCR)-based multiplex dual probe assay, the test for chlamydia...
BOULDER, Colo., and PLEASANTON, Calif., June 2, 2011 /PRNewswire/ -- Clovis Oncology, Inc. and Roche (SIX: RO, ROG; OTCQX: RHHBY), announced today that they have entered into an agreement to develop an in vitro PCR (Polymerase Chain Reaction) based companion diagnostic test. The goal is to identify activating epidermal growth factor receptor (EGFR) mutations in patients with non-small cell lung cancer (NSCLC), including the EGFR T790M mutation. "Once again we are able to demonstrate...
PLEASANTON, Calif., May 6, 2011 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has filed for FDA clearance of its Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) tests. When cleared this standardized and fully automated test will help physicians detect and subsequently treat patients with the disease. Clinical trial data will be presented at the 21st European Congress of Clinical Microbiology and Infectious Diseases (ECCMID, May 7-13, Milan, Italy)...
PLEASANTON, Calif., Feb. 4, 2011 /PRNewswire/ -- Roche (SIX: RO, ROG; Pink Sheets: RHHBY) announced today that the cobas® TaqScreen DPX Test for use on the cobas s 201 system is now available in the US. It is the first commercial test to quantify parvovirus B19 and detect hepatitis A virus (HAV) simultaneously in one assay in human plasma. Human plasma is used to create treatments for life-threatening and chronic diseases and disorders such as hemophilia and primary immunodeficiency...
PLEASANTON, Calif., Oct. 25 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food & Drug Administration (FDA) has approved the real-time PCR COBAS® TaqMan® HCV Test, v2.0. Clinical research organizations have depended on COBAS® TaqMan® technology to support hepatitis C pharmaceutical trials and development. This new test will help clinicians to more confidently and effectively monitor their patients, and to improve treatment outcomes. "This...
