Philadelphia, PA – Acute lymphoblastic leukemia (ALL) is the most common childhood cancer, representing more than 30% of all pediatric cases. A pilot study in The Journal of Molecular Diagnostics, published by Elsevier, confirms the feasibility of implementing an RNA sequencing analysis (RNA-Seq) workflow for clinical diagnosis of molecular subtypes...
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MEMPHIS, Tenn. – Scientists at St. Jude Children’s Research Hospital described the gene regulatory networks contributing to differences between subtypes of the most common childhood cancer, acute lymphoblastic leukemia (ALL). The work examined chromatin, the packaging that compacts DNA, in a cohort of patient samples six times greater than any...
Nice, France – Roca Therapeutics (Roca), a pioneer in non-invasive, first-in-class therapies for severe ocular diseases, today announces the granting of Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for its lead clinical candidate, RCT002, in the treatment of Radiation Maculopathy. This regulatory milestone is the result of Roca’s...
MISSISSAUGA, ON – Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that on March 5, 2024, the Institut National d’Excellence en Santé et en Services Sociaux (INESSS) recommended Columvi® (glofitamab for injection) for public reimbursement. This recommendation follows the recent positive recommendation from the Canadian Agency for Drugs and...
The VENTANA TROP2 (EPR20043) RxDx Device is an immunohistochemistry (IHC) assay combined with a digital pathology algorithm to determine patient treatment. The device uses artificial intelligence-based image analysis with a level of diagnostic precision not possible with traditional manual scoring methods. This Breakthrough Device Designation (BDD) demonstrates Roche’s continued...
BASEL, Switzerland – Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it introduces the cobas® HDV test for use on the cobas® 5800/6800/8800 systems, a diagnostic tool for the detection and quantification of Hepatitis D Virus (HDV) RNA, in countries accepting the CE mark. Available on the industry-leading cobas 5800/6800/8800...
Roche Diagnostics today announced the launch of a new tuberculosis test for South Africa. Worldwide, South Africa is one of the countries with the highest prevalence of tuberculosis. The new kit detects different species of Mycobacterium from human sputum samples using the LightCycler® 2.0 Instrument. The diagnosis of tuberculosis in...
Basel, Switzerland – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the pivotal Phase III study (FENhance 1) of fenebrutinib in RMS met its primary endpoint, showing clinically meaningful and statistically significant results. The study demonstrated that fenebrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor, markedly reduced the annualised...
Basel, Switzerland – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the phase III MAJESTY study in adults with primary membranous nephropathy met its primary endpoint, showing statistically significant and clinically meaningful results with Gazyva®/Gazyvaro® (obinutuzumab). Results show that significantly more people achieved complete remission at two years (104...
Basel, Switzerland – Roche (SIX: RO, ROG; OTCQX: RHHBY) presents new data for OCREVUS® (ocrelizumab) and the investigational Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain (24-26 September). New data show that treatment...