Ovarian cancer is one of the most common causes of cancer deaths among women and has a five-year survival rate of around 50%. The disease is particularly lethal because it often doesn’t cause symptoms in its early stages. The absence of effective screening tools and the disease’s asymptomatic nature contribute to its diagnoses during the later stages when treatment options are less effective. A cost-effective, accessible detection method could revolutionize the clinical approach to ovarian cancer screening and potentially save lives. Although liquid biopsy technologies, which analyze blood for tumor-derived DNA, have been explored for noninvasive cancer detection, their utility in ovarian cancer has been limited. Now, a retrospective study presented at AACR 2024 has demonstrated that a blood-based machine learning assay, which combines cell-free DNA (cfDNA) fragment patterns with levels of the proteins CA125 and HE4, can effectively distinguish patients with ovarian cancer from healthy controls or patients with ...
Hemoglobinopathies, the most widespread inherited conditions globally, affect about 7% of the population as carriers, with 2.7% of newborns being born with these conditions. The spectrum of clinical manifestations ranges from mild cases with minimal symptoms to severe disorders like sickle cell disease and Hb Bart’s hydrops fetalis, which can cause extensive organ damage and necessitate lifelong blood transfusions. Capillary electrophoresis has been established as a reliable method for newborn screening of hemoglobin disorders, offering high-quality outcomes. Now, a next-generation instrument dedicated to newborn hemoglobin screening offers a smooth workflow and excellent analytical capabilities. Sebia’s (Lisses, France) CAPILLARYS 3 DBS instrument is an automated, multitasking capillary electrophoresis instrument that uses 12 capillaries simultaneously for hands-free electrophoretic separation at high throughput. Designed to detect both standard (F and A) and abnormal hemoglobins (S, C, E, D, and Bart’s) in dried blood samples collected on filter paper from newborns, this instrument provides ...
Culmination Bio has announced a partnership with BillionToOne to develop and advance diagnostic tests in oncology that are accessible to all. Both companies will work together to facilitate the development and validation of robust and impactful oncology diagnostics. According to the Centers for Disease Control, skin cancer is currently the most common type of cancer in the US, responsible for more than 9,500 new cases every day, followed by lung cancer, prostate cancer and breast cancer. The molecular diagnosis company, BillionToOne, is developing these new diagnostics in an effort to address the challenges associated with accurately profiling cancer to assess the best treatment and monitor responses to determine the effectiveness of the cancer treatment. As part of the agreement, the data and technology company will use its Data Lake and patient recruitment abilities to help BillionToOne validate the clinical performance of two new diagnostic tests: Northstar Select, an ultra-sensitive, NGS-based ...
Small cell lung cancer (SCLC), a rapidly progressing neuroendocrine malignancy, exhibits low survival rates. Despite its molecular and clinical heterogeneity, SCLC is presently treated as a single entity, without the use of predictive biomarkers, which leads to poor patient outcomes. Recent research has proposed dividing SCLC into four subtypes—labeled “A”, “N”, “P”, and “I”—each characterized by distinct molecular signatures and treatment vulnerabilities. Initially, this classification relied on gene expression (RNA-seq) data. Further studies indicated that the same categorization could be recapitulated through the use of a reduced-representation bisulfite sequencing (RRBS) methylation profile. Although this classification system effectively predicts treatment responses, including to immunotherapy, in retrospective analyses, both RNAseq and RRBS techniques are too labor-intensive and slow for quick treatment decisions in an aggressive malignancy. Now, a pilot study published in the journal Cancer Cell has demonstrated the feasibility of a simple PCR assay to accurately differentiate between SCLC SCLC subtypes. ...
Arboviruses represent an emerging global health threat, exacerbated by climate change and increased international travel that is facilitating their spread across new regions. Chikungunya, dengue, West Nile, and Zika viruses are the four most significant arboviruses of concern, all being transmitted by mosquito bites. In 2023 alone, dengue virus accounted for over five million cases and 5,000 deaths worldwide. Traditionally, assessing the risk of arboviruses in blood donors has relied on single-pathogen tests, dual-pathogen tests, or donor history questionnaires, with those having traveled to or lived in areas endemic for arboviruses being temporarily deferred. Now, an in vitro nucleic acid test that can detect all four types of arboviruses can help minimize the risk of blood transfusion-transmitted infections. The new Procleix ArboPlex Assay from Grifols (Barcelona, Spain;) is an automated nucleic acid test (NAT) specifically validated for screening blood donors to detect chikungunya, dengue, West Nile and Zika viruses. The ...
Recently, Hengrui Pharmaceuticals’ subsidiaries, Shanghai Shengdi Pharmaceuticals Co., Ltd. and Suzhou Shengdia Biopharmaceuticals Co., Ltd. have received the Approval Notice of Drug Clinical Trial issued by the State Drug Administration, which authorizes to conduct the Phase Ib/II clinical study of Adebelizumab Injection in combination with SHR-A1811 and chemotherapy for HER2-expressing advanced adenocarcinoma of the stomach or the gastroesophageal junction. In 2020, gastric cancer ranked 5th in global cancer incidence and 4th in mortality. Among them, 43.9% of new cases and 48.6% of deaths will occur in China, with 479,000 new cases and 374,000 deaths, both ranking third in China in terms of cancer incidence and mortality. Human Epidermal Growth Factor Receptor (HER2)-positive gastric cancer is a unique subtype of the disease, which requires different diagnostic and therapeutic strategies from HER2-negative gastric cancer. The global reported HER2-positive rate of gastric cancer is 7.3%-20.2%, and the HER2-positive rate of gastric cancer in ...
Researchers from the University of Edinburgh and the University of Aberdeen have revealed that an aptamer (biological molecules) tool can successfully detect early signs of motor neurone disease (MND). Published in Acta Neuropathologica, the aptamer was collaboratively developed by scientists at the University of Edinburgh, the Instituto Italiano di Tecnologia, King’s College London and the Centre for Genomic Regulation in Spain. Currently affecting around 5,000 people in the UK, MND is a fatal, rapidly progressing neurological condition caused by the accumulation of proteins in the brain that clump together to gradually stop cells from working. The new method works to detect MND by targeting the protein association with the disease in brain tissue before the onset of symptoms. It uses small biological molecules to bind to protein clumps that accumulate in the brains of people living with MND. Funded by Target ALS, researchers from Edinburgh and Aberdeen discovered that the ...
Dive Brief Beckman Coulter received a warning letter in March after inspectors found fault with quality practices at a facility that makes immunoassay analyzer instruments and tests. The Food and Drug Administration, which published the letter Tuesday, said Beckman failed to adequately establish procedures for risk analysis and other activities at a facility in Minnesota. Beckman Coulter responded to the observations in January and February 2024, but the FDA said the responses to specific problems were either inadequate or impossible to assess at this time. Dive Insight The warning letter names the DxI 9000 Access Immunoassay analyzer instrument system and assays as the device that is “adulterated” because of the compliance failings. Rainer Blair, CEO of Beckman’s parent company Danaher, singled out Dxl 9000 as a new product that is “enabling faster, more accurate patient diagnosis” on an earnings call in January. Beckman was a growth driver in the fourth ...
Sepsis, a critical condition that arises from organ dysfunction due to severe infection, can progress to severe sepsis and septic shock, leading to multi-organ failure and increased mortality rates. The complexity of diagnosing sepsis stems from the absence of a definitive test, with current detection methods depending on broad-ranged biomarkers such as CRP, PCT, and lactate levels. The disease’s variability and the general approach of administering broad-spectrum antibiotics, antivirals, and antifungals underscore the urgency for more specific diagnostic and treatment strategies. New research to be presented at ECCMID 2024 highlights the success achieved by researchers in identifying distinct molecular signatures associated with the clinical signs of sepsis that could enable more accurate diagnosis and prognosis of the condition, as well as help design targeted therapies for patients who stand to benefit the most. In this study, researchers from Lund University (Lund, Sweden) analyzed plasma samples collected over a period of ...
BY SEAN WHOOLEY The TULSA-PRO system from Profound Medical. [Image from Siemens Healthineers]Profound Medical (Nasdaq:PROF) announced today that it entered into a non-exclusive collaboration with Siemens Healthineers. The two companies aim to lay the groundwork for Profound to begin marketing a complete therapeutics solution. They want to combine the Profound TULSA-PRO system with the Siemens Magnetom Free.Max magnetic resonance (MR) scanner. While this combination falls under the remit of Profound’s own sales force, the company also plan to market TULSA-PRO as a standalone offering. This enables customers to use the technology with the MR hardware of their choice. TULSA-PRO performs the company’s transurethral ultrasound ablation (TULSA) procedure. It employs real-time MR guidance for precision while killing targeted prostate tissue through sound absorption technology. The system enables surgeons to ablate whole- or partial-gland prostate tissue in patients with low- intermediate- or high-risk prostate cancer. It also treats benign prostatic hyperplasia (BPH). ...
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