Search Results for “Roche” – Page 11 – media

New Highly-Sensitive Test to Help More Easily Diagnose B-Cell Lymphoma

B-cell lymphoma, a cancer primarily originating in the lymphatic system, represents about 85% of non-Hodgkin lymphoma (NHL) diagnoses. NHL ranks as the tenth most prevalent cancer globally, claiming over 250,000 lives annually. In its early stages, NHL can manifest with symptoms such as swollen lymph nodes, fever, fatigue, loss of appetite, or a red rash. These symptoms, however, can mimic the body’s typical response to infections, making a precise diagnosis crucial. symptoms of lymphoma can appear similar to the body’s normal reactive response to an infection. Now, a first-of-its-kind assay can offer diagnostic certainty for patients with suspected B-cell lymphoma. Roche (Basel, Switzerland) has introduced the first clinically approved, highly sensitive in-situ hybridization (ISH) test, the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, available in regions accepting the CE Mark. This assay stands out as the first clinically approved ISH test designed to detect the entire range ...
- Source: drugdu
- 94
- July 8, 2024
Semi-Automated System Rapidly Identifies Pathogenic Genetic Variant Causing Rare Diseases

Many patients with rare diseases (50-75%) do not receive a diagnosis after genomic sequencing, often due to insufficient information on the variants identified. Reassessing data over time with new genetic insights can improve diagnostic rates. However, reanalyzing genetic data in clinical laboratories is often hampered by time and resource limitations. Now, a novel semi-automated system enables rapid reanalysis of unresolved rare disease cases by regularly comparing patient genomic data with the latest global research findings, aiming to identify elusive disease-causing genetic variants. Developed by Mayo Clinic researchers in 2022 (Rochester, MN, USA), the system, named RENEW (REanalysis of NEgative Whole-exome/genome data), incorporates an advanced filtering system that scans new genetic data to identify the variants responsible for a patient’s condition. A recent study demonstrated RENEW’s effectiveness, providing likely diagnoses for 63 out of 1,066 previously undiagnosed cases. RENEW can review each of the 5,741 prioritized genomic variants in about 20 ...
- Source: drugdu
- 88
- June 29, 2024
FDA Approves GSK’s Arexvy to Prevent Respiratory Syncytial Virus in Adults Aged 50-59 with Increased Risk

Don Tracy, Associate Editor Arexvy receives expanded indication to include adults aged 59 years and younger to prevent RSV lower respiratory tract disease. GSK’s Arexvy (RSV Vaccine, Adjuvanted) has been approved by the FDA for an expanded indication to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in adults aged 50-59 years with an increased risk. The approval for this age group was based on encouraging results from a Phase III trial (NCT05590403) that evaluated the immune response and safety of Arexvy in adults aged 50-59, including those with underlying medical conditions. Arexvy was previously approved for adults aged 60 years and older for the same purpose in May 2023. Additionally, the Advisory Committee on Immunization Practices (ACIP) recommended its use through shared clinical decision-making.1 “[This] approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50-59 who are at increased risk. For those ...
- Source: drugdu
- 104
- June 12, 2024
Merck Sees Pipeline Diversification Opportunity in $1.3B EyeBio Acquisition

Merck’s EyeBio acquisition brings a lead program ready for pivotal testing in diabetic macular edema. The therapy could pose competition to Eylea, the blockbuster Regeneron Pharmaceuticals eye drug. By Frank VinluanMerck is on the hunt for drugs with blockbuster potential to make up for declining revenue when its top product, the cancer immunotherapy Keytruda, loses patent protection in the next few years. The pharmaceutical giant is getting a contender through the acquisition of a clinical-stage startup whose lead program is on track to begin pivotal testing in diabetic macular edema. According to deal terms announced Wednesday, Merck is acquiring Eyebiotech Limited, or EyeBio, for $1.3 billion in cash up front. Shareholders of the New York-based company could receive up to $1.7 billion more in milestone payments. EyeBio develops drug for retinal conditions in which inflammation leads to the breakdown of the inner blood-retinal barrier. This breakdown leads to vascular leakage, ...
- Source: drugdu
- 99
- June 1, 2024
FDA grants priority review to Genentech’s Inavolisib

Genentech, a member of the Roche Group, announced that the USFDA has accepted the company’s new drug application and granted priority review to inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance) and fulvestrant. The inavolisib-based regimen was evaluated in adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. The priority review is based on the positive Phase III INAVO120 results, which showed the inavolisib-based regimen more than doubled progression-free survival, reducing the risk of disease worsening or death by 57 per cent compared to palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43, 95 per cent CI: 0.32-0.59, p<0.0001) in the first-line setting. Overall survival (OS) data were immature at the time of primary analysis, but a clear positive trend was observed ...
- Source: drugdu
- 83
- May 31, 2024
Lipoprotein Blood Test Detects Hereditary Cardiovascular Risk

Lipoprotein (a), or Lp(a), is increasingly recognized as a critical but under-acknowledged potential risk factor for cardiovascular diseases, which are a significant public health concern. Around 20% of the global population has high levels of Lp(a), which heightens their risk of conditions such as myocardial infarction and stroke. Elevated Lp(a) levels contribute to the accumulation of lipids within artery walls, facilitating plaque formation and heightening the risk of cardiovascular events. While factors such as menopause, and kidney or liver diseases, as well as hyperthyroidism can affect Lp(a) levels, over 90% of the variability in Lp(a) levels is due to genetic differences in the lipoprotein (a) (LPA) gene. Consequently, testing for Lp(a) is a crucial diagnostic tool that helps clinicians accurately evaluate cardiovascular risk, and its integration into routine diagnostics is anticipated soon. Roche’s (Basel, Switzerland) Tina-quant lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and ...
- Source: drugdu
- 105
- May 28, 2024
Lipoprotein Blood Test Detects Hereditary Cardiovascular Risk

Lipoprotein (a), or Lp(a), is increasingly recognized as a critical but under-acknowledged potential risk factor for cardiovascular diseases, which are a significant public health concern. Around 20% of the global population has high levels of Lp(a), which heightens their risk of conditions such as myocardial infarction and stroke. Elevated Lp(a) levels contribute to the accumulation of lipids within artery walls, facilitating plaque formation and heightening the risk of cardiovascular events. While factors such as menopause, and kidney or liver diseases, as well as hyperthyroidism can affect Lp(a) levels, over 90% of the variability in Lp(a) levels is due to genetic differences in the lipoprotein (a) (LPA) gene. Consequently, testing for Lp(a) is a crucial diagnostic tool that helps clinicians accurately evaluate cardiovascular risk, and its integration into routine diagnostics is anticipated soon. Roche’s (Basel, Switzerland) Tina-quant lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and ...
- Source: drugdu
- 123
- May 27, 2024
Pharmed Vietnam 2024

Organiser：Adpex JSC Time：11- 14 September 2024 address：Lawrence S. Ting Building 801 Nguyen Van Linh Parkway, Dist. 7 Ho Chi Minh City Vietnam Exhibition hall：Saigon Exhibition & Convention Center Product range: Medical Products Exhibition area: Medical equipment and instruments, medical consumables, medical dressings, surgical equipment, rescue equipment, diagnostic equipment and supplies, ophthalmic instruments and equipment, ENT equipment, dental equipment and supplies, medical reagents and equipment, medical health products and equipment, medical institutions and laboratory technology equipment, medical information and technology exchange, beauty equipment Analytical Instruments Exhibition area: Optical analysis instruments, mass spectrometers, spectrometers, chromatographs, spectrometers, electrochemical analysis instruments, X-ray analysis instruments, gas chromatography, liquid chromatography, thermal analysis instruments, all kinds of portable instruments, surface analysis instruments, nuclear analysis instruments, elemental analysis instruments, process analysis instruments, composition analysis instruments, injection analysis instruments and other general analytical instruments Laboratory Equipment Exhibition area: Laboratory instruments and equipment, laboratory automation and accessories, optical instruments and equipment, ...
- Source: drugdu
- 167
- May 27, 2024
HPV Self-Collection Solution Improves Access to Cervical Cancer Testing

Annually, over 604,000 women across the world are diagnosed with cervical cancer, and about 342,000 die from this disease, which is preventable and primarily caused by the Human Papillomavirus (HPV). A staggering 90% of these deaths occur in low- and middle-income countries. Screening for HPV is crucial as it helps identify women at risk of developing cervical cancer, thereby enabling early intervention before the cancer can develop. In regions where healthcare resources are scarce, enhancing the accessibility of screening and reducing obstacles to sample collection are critical to preventing this disease. Now, a novel HPV self-sampling method expands the availability of cervical cancer screening by allowing patients to collect their samples privately while at a healthcare facility. Roche (Basel, Switzerland) has received FDA approval for its HPV self-collection solution, one of the first available in the United States where more than half of the women diagnosed with cervical cancer have ...
- Source: drugdu
- 98
- May 21, 2024
Enhanced Rapid Syndromic Molecular Diagnostic Solution Detects Broad Range of Infectious Diseases

GenMark Diagnostics (Carlsbad, CA, USA), a member of the Roche Group (Basel, Switzerland), has rebranded its ePlex® system as the cobas eplex system. This rebranding under the globally renowned cobas name underscores Roche’s dedication to ongoing enhancement across its entire product line, encompassing everything from raw materials and manufacturing to quality control. The cobas eplex system has been redesigned with new features that enhance usability, reliability, and serviceability. Notable improvements include onboard quality control tracking and monitoring, eSignature capabilities, onboard epidemiology reports, email alerts, and customizable comments to support clinical decisions. Additionally, GenMark has refined its cartridge manufacturing processes, ensuring an adequate supply and enhanced validity. The system offers tests for infectious diseases, focusing on panels for respiratory and bloodstream infections, which can progress to sepsis, and the company is developing panels for gastrointestinal infections, meningitis, and encephalitis. The cobas eplex system integrates the entire order-to-report process to maximize the ...
- Source: https://www.labmedica.com/microbiology/articles/294801045/enhanced-rapid-syndromic-molecular-diagnostic-solution-detects-broad-range-of-infectious-diseases.html
- 95
- May 4, 2024

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