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Roche Announces the First FDA-approved CMV Test for Use in Hematopoietic Stem Cell Transplant Recipients

Roche (SIX: RO, ROG; OTCQX: RHHBY) recently announced the United States Food and Drug Administration (FDA) approval of the first cytomegalovirus (CMV) test for use in hematopoietic stem cell transplant recipients. With this approval, the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is available for monitoring CMV treatment in all types of transplant patients in the USA. The test was the first in vitro diagnostic test conforming to the WHO International Standard, making it possible for laboratories worldwide to obtain comparable results when testing for CMV and it is now the most commonly used in vitro diagnostic test for CMV solid organ transplant recipients in the USA.

New Publication Shows Consistent Clinical Performance In Screening Common Fetal Trisomies With Harmony Prenatal Test

Roche (SIX: RO, ROG; OTCQX:RHHBY) and Ariosa Diagnostics, Inc., a global leader in non-invasive prenatal testing (NIPT) 1 technology and maker of the Harmony™ Prenatal Test, today announced the results of a new clinical study on the company’s targeted cell-free DNA analysis using microarray quantitation which demonstrated high sensitivity, specificity and extremely low false positive rates for prenatal assessment of Down syndrome and other chromosomal disorders. The consistent assay performance of the Harmony Prenatal Test, published in Prenatal Diagnosis, was attributed to its targeted cell-free DNA analysis method regardless of whether evaluated via microarray or next generation sequencing (NGS).

Ariosa Diagnostics’ Harmony Prenatal Test Now Performed in Australia and United Kingdom at Sonic Healthcare Laboratories

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Ariosa Diagnostics, Inc., a global leader in non-invasive prenatal testing (NIPT) technology and maker of the Harmony™ Prenatal Test, in conjunction with Australian company Sonic Healthcare, today announced that Sonic Healthcare has been granted a license to perform the Harmony Prenatal Test in its Australian and United Kingdom labs. Under the license, Sonic Healthcare will provide the Harmony Prenatal Test and cell-free DNA System, developed at Ariosa’s California laboratory, through Sonic Genetics in Australia and Sonic’s UK counterpart, The Doctors Laboratory (TDL).

Roche To Develop Companion Diagnostic Test For Acute Coronary Syndrome

Roche (SIX: RO, ROG; OTCQX: RHHBY) recently announced it has entered into an agreement to develop a companion diagnostic (CDx) test for dalcetrapib, a therapeutic from DalCor Pharmaceuticals (DalCor), which will target patients with a specific genotype who have experienced a recent Acute Coronary Syndrome (ACS) event. The CDx test from Roche will be used in a phase III clinical trial that will seek to validate the clinical efficacy of dalcetrapib, an investigational medicine that according to a recently published analysis by the Montreal Heart Institute, could potentially reduce cardiovascular morbidity and mortality by as much as 39 percent in patients with a specific genetic profile.

World Health Organization Recommends Use of p16 IHC to Help Diagnose High-grade Cervical Disease

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, recently announced that the World Health Organization (WHO) has issued new guidance recommending the use of p16 immunohistochemistry (IHC) testing to improve the detection of pre-cancerous cervical disease. In doing so, the WHO is the first global organization to issue written recommendations on the use of p16 after the College of American Pathologists (CAP) and the American Society for Colposcopy and Cervical Pathology (ASCCP) provided similar guidance in 2012.