FDA Takes Action to Reduce EtO Use

Shutdowns earlier this year of two facilities that use ethylene oxide (EtO) to sterilize medical devices prompted FDA to monitor for supply shortages in the industry because EtO is such a popular sterilization method for medical devices. This week the agency revealed steps it will take to reduce medtech's reliance on EtO sterilization. EtO is a flammable, colorless gas used to sterilize equipment and plastic devices that cannot be sterilized by steam, such as medical equipment. In fact, about half of all sterilized medical devices undergo sterilization using this gas. Breathing air containing elevated EtO levels over many years has been linked to increased risk of some types of cancers, including cancers of the white blood cells (such as non-Hodgkin's lymphoma, myeloma, and lymphomatic leukemia). It also has been found to cause breast cancer in women. In July, FDA challenged medtech innovators to identify new sterilization methods and technologies that could be used as alternatives to EtO. The agency also challenged the industry to identify strategies or technologies that can significantly reduce the amount of EtO used to sterilize medical devices. The agency reported that 46 companies responded to the challenge and from these FDA selected 12 applicants that it will work with to accelerate the development and review of innovative technologies for sterilization processes. The selected ideas include such things as&Acir...
Source: MDDI - Category: Medical Devices Authors: Tags: Sterilization Regulatory and Compliance Source Type: news

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Conclusion: Our study demonstrated that the aberrant expression of CDCA gene family members plays an indispensable role in tumorigenesis. PMID: 31955607 [PubMed - as supplied by publisher]
Source: Future Medicine: Biomarkers in Medicine - Category: Internal Medicine Tags: Biomark Med Source Type: research
Publication date: Available online 20 January 2020Source: Carbohydrate PolymersAuthor(s): Nadezhda E. Ustyuzhanina, Maria I. Bilan, Andrey S. Dmitrenok, Alexander S. Shashkov, Nora M.A. Ponce, Carlos A. Stortz, Nikolay E. Nifantiev, Anatolii I. UsovAbstractFucosylated chondroitin sulfate (FCS) HeSp was isolated from the Patagonian sea cucumber Hemioedema spectabilis. Ion-exchange chromatography was applied for purification of the FCS from the crude extract of sulfated polysaccharides. Analysis of monosaccharide and sulfate content of HeSp revealed the molar ratio of GlcA:GalNAc:Fuc:SO3Na as 1.15:1:1.1:3.9. Molecular weight...
Source: Carbohydrate Polymers - Category: Biomedical Science Source Type: research
Cancer immune evasion is achieved through multiple layers of immune tolerance mechanisms including immune editing, recruitment of tolerogenic immune cells, and secretion of immunosuppressive cytokines. Recent success with immune checkpoint inhibitors in cancer immunotherapy suggests a dysfunctional immune synapse as a pivotal tolerogenic mechanism. Tumor cells express immune synapse proteins to suppress the immune system, which is often modulated by epigenetic mechanisms. When the methylation status of key immune synapse genes was interrogated, we observed disproportionately hypermethylated costimulatory genes and hypometh...
Source: Journal of Clinical Investigation - Category: Biomedical Science Authors: Source Type: research
Increased rates of locoregional recurrence are observed in patients with basal-like breast cancer (BC) despite the use of radiation therapy (RT); therefore, approaches that result in radiosensitization of basal-like BC are critically needed. Using patients’ tumor gene expression data from 4 independent data sets, we correlated gene expression with recurrence to find genes significantly correlated with early recurrence after RT. The highest-ranked gene, TTK, was most highly expressed in basal-like BC across multiple data sets. Inhibition of TTK by both genetic and pharmacologic methods enhanced radiosensitivity in mul...
Source: Journal of Clinical Investigation - Category: Biomedical Science Authors: Source Type: research
Antigen receptor–dependent (AgR-dependent) stimulation of the NF-κB transcription factor in lymphocytes is a required event during adaptive immune response, but dysregulated activation of this signaling pathway can lead to lymphoma. AgR stimulation promotes assembly of the CARMA1-BCL10-MALT1 complex, wherein MALT1 acts as (a) a scaffold to recruit components of the canonical NF-κB machinery, and (b) a protease to cleave and inactivate specific substrates, including negative regulators of NF-κB. In multiple lymphoma subtypes, malignant B cells hijack AgR signaling pathways to promote their own growth...
Source: Journal of Clinical Investigation - Category: Biomedical Science Authors: Source Type: research
The protein-protein interaction between menin and mixed lineage leukemia 1 (MLL1) plays a critical role in acute leukemias with translocations of the MLL1 gene or with mutations in the nucleophosmin 1 (NPM1) gene. As a step toward clinical translation of menin-MLL1 inhibitors, we report development of MI-3454, a highly potent and orally bioavailable inhibitor of the menin-MLL1 interaction. MI-3454 profoundly inhibited proliferation and induced differentiation in acute leukemia cells and primary patient samples with MLL1 translocations or NPM1 mutations. When applied as a single agent, MI-3454 induced complete remission or ...
Source: Journal of Clinical Investigation - Category: Biomedical Science Authors: Source Type: research
Publication date: Available online 21 January 2020Source: Sensors and Actuators B: ChemicalAuthor(s): Ying Li, Pengchao Zhang, Tao Li, Rui Hu, Jiang Zhu, Ting He, Yunhuang Yang, Maili LiuAbstractCancer cells’ MMP9 activity plays vital roles in tumor development. Tumor cells are in an adhesion profile during cell-cell and cell-matrix interaction. However, it is challenging for current platforms (e.g., typical droplet systems) to measure MMP9 secreted by single cells in an adhesion profile and retrieve the cells of interest for downstream analysis. Herein, we report a single-cell protease sensor (SCPS) based on ‘...
Source: Sensors and Actuators B: Chemical - Category: Chemistry Source Type: research
In this study, protein-based nanoparticles were constructed with TRAIL and a dipeptide, diphenylalanine (FF), through molecular self-assembly. TRAIL-FF nanoparticles with sizes ranging from 60 nm to 500 nm could be prepared by controlling the concentration and the ratio of the two components. These nanoparticles could locate around the cytomembrane of MCF-7 cells due to the specific interaction between TRAIL and death receptors, thus transduce apoptotic signal. Therefore, the TRAIL-FF nanoparticles showed distinct killing effect on the cancer cells, such as MCF-7 and H460 cells, and the IC50 of the nanopartic...
Source: Colloids and Surfaces A: Physicochemical and Engineering Aspects - Category: Chemistry Source Type: research
Conclusions: CAR T cell therapies have demonstrated the clinical benefits of harnessing our body's own defenses to combat tumor cells. Similar research is being conducted on lesser known modifications and gene-modified immune cells, which we highlight in this review. Introduction Chimeric antigen receptors and engineered T cell receptors (based on previously identified high affinity T cell receptors) function by redirecting T cells to a predefined tumor-specific (or tumor-associated) target. Most of these modifications use retroviral or lentiviral vectors to integrate the construct, and most of the receptors ...
Source: Frontiers in Oncology - Category: Cancer & Oncology Source Type: research
Objective: To investigate the clinical features of 2nd hematological malignancies post to the initial cancer treatment.METHODS: A retrospective study was performed to analyze the available clinical data of 116 patients diagnosed with 2nd hematologic malignancies after treatment of various malignant tumors from June 1998 to June 2018 at Sun Yat-sen University cancer center.RESULTS: The characteristics of the 116 patients diagnosed with 2nd hematological cancer post to initial cancer treatment were indicated as following: 62 males and 54 females. The primary tumor category was grouped as (according to ICD-10 International Di...
Source: Blood - Category: Hematology Authors: Tags: 904. Outcomes Research-Malignant Conditions Source Type: research
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