Assay

BD Onclarity™ HPV Assay Receives FDA Approval for Use with Both BD SurePath™ Liquid-based Pap Test and Hologic ThinPrep® Pap Test

Retrieved on: 
Tuesday, February 21, 2023

FRANKLIN LAKES, N.J., Feb. 21, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) market approval for the BD Onclarity™ HPV Assay to be used with the ThinPrep® Pap Test.

Key Points: 
  • The BD SurePath™ Liquid-based Pap Test vial and the Hologic ThinPrep® Pap Test PreservCyt® Solution vial are the two most common Pap vials used by laboratories in the United States.
  • HPV31 poses the second-highest risk for cervical pre-cancer, and the BD Onclarity™ HPV Assay is the only FDA-approved assay that screens for it individually."
  • The BD Onclarity™ HPV Assay detects and identifies 14 high-risk human papillomavirus (HPV) types in a single analysis.
  • The ThinPrep® Pap Test with the BD Onclarity™ HPV Assay can be used on the BD COR™ or BD Viper™ LT instrument platforms without the need to change current cytology equipment.

Global Mycoplasma Diagnostics Market 2022 to 2027: Featuring Creative Bioarray, Eurofins Scientific, F. Hoffmann-La Roche and Genecopoeia Among Others - ResearchAndMarkets.com

Retrieved on: 
Monday, January 23, 2023

The report presents a detailed Ansoff matrix analysis for the Global Mycoplasma Diagnostics Market.

Key Points: 
  • The report presents a detailed Ansoff matrix analysis for the Global Mycoplasma Diagnostics Market.
  • The analyst analyses the Global Mycoplasma Diagnostics Market using the Ansoff Matrix to provide the best approaches a company can take to improve its market position.
  • The report offers a comprehensive evaluation of the Global Mycoplasma Diagnostics Market.
  • The Global Mycoplasma Diagnostics Market is segmented based on Type, Technique, Application, End-user, and Geography.

ProterixBio Announces Commercial Offering of Quantitative Soluble ST2 Assay

Retrieved on: 
Friday, February 10, 2023

BILLERICA, Mass., Feb. 10, 2023 /PRNewswire/ -- ProterixBio, Inc. today announced the offering of the Presage® ST2 Assay as a testing service through ProterixBio's high-complexity CLIA laboratory.

Key Points: 
  • BILLERICA, Mass., Feb. 10, 2023 /PRNewswire/ -- ProterixBio, Inc. today announced the offering of the Presage® ST2 Assay as a testing service through ProterixBio's high-complexity CLIA laboratory.
  • The protein ST2 (suppressor of tumorigenicity 2) is a member of the interleukin-1 receptor family.
  • The Presage® ST2 assay provided by ProterixBio is a 510(k) cleared device 5 providing a quantitative measure of soluble ST2 in serum or plasma (K3EDTA and Heparin).
  • We utilize sST2 as a complement to proBNP — Soluble ST2 provides appreciation of the chronicity of the underlying disease state.

Catalent to Expand Its Biologics Analytical Services with New Facility in Durham, North Carolina

Retrieved on: 
Wednesday, December 14, 2022

SOMERSET, N.J., Dec. 14, 2022 /PRNewswire-PRWeb/ -- Catalent, the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced that it is to establish a new biologics analytical center of excellence in Durham, within North Carolina's Research Triangle, to offer comprehensive standalone analytical development and testing for biologic drug modalities, including cell and gene therapies.

Key Points: 
  • Catalent plans to invest up to $40 million to fit out the 80,000 square-foot facility with state-of-the-art equipment and instrumentation, including automation and digitization capabilities.
  • Catalent expects to complete the facility by mid-2023, which will support the hiring of over 200 scientists and technicians over the next five years.
  • More than 45 commercially approved products have employed Catalent Biologics' manufacturing and packaging capabilities.
  • Using advanced technologies and tailored solutions from clinical to commercial supply, Catalent brings better biologic and advanced treatments to patients, faster.

Mission Bio partners with global pharma and academic institutions to demonstrate Tapestri® Platform's translational utility for precision therapeutics at ASH

Retrieved on: 
Wednesday, December 7, 2022

SOUTH SAN FRANCISCO, Calif., Dec. 7, 2022 /PRNewswire/ -- Mission Bio, the pioneer in high-throughput single-cell DNA and multi-omics analysis, and multiple biopharma and academic partners are presenting data from the company's Tapestri® Platform on a range of topics at the 64th Annual American Society of Hematology (ASH) Annual Meeting and Exposition, beginning this weekend in New Orleans, LA. In all, Mission Bio and its partners will share 15 heme-oncology topics highlighting the use of single-cell DNA + protein multi-omics to better understand resistance mechanisms and drivers of relapse, improve identification of Measurable Residual Disease (MRD), and precisely characterize CAR T cell therapies.  These include presentations from Servier Pharmaceuticals and researchers at Memorial Sloan Kettering Cancer Center (MSK) that demonstrate Tapestri's® ability to bridge the gap between translational research and precision therapeutics, providing a deeper understanding of the patient journey and unlocking novel therapeutic approaches. These include the following:

Key Points: 
  • Researchers identified potential mechanisms of acquired resistance in patients with IDH1-mutated acute myeloid leukemia (AML) using single-cell DNA sequencing with Tapestri.
  • "Mission Bio has led the way into a new era for precision therapeutics with single-cell DNA + protein multi-omics," said Todd Druley, Chief Medical Officer at Mission Bio.
  • Mission Bio's multi-omics approach improves time-to-market for new therapeutics, including innovative cell and gene therapies that provide new pathways to health.
  • Tapestri is the only commercialized multi-omics platform capable of analyzing DNA and protein simultaneously from the same sample at single-cell resolution.

Environmental Monitoring: Evaluating Cellular Response Pathways in Complex Mixtures, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Monday, December 5, 2022

TORONTO, Dec. 5, 2022 /PRNewswire-PRWeb/ -- Cell-based in vitro bioassays have been used in environmental monitoring to detect and quantify the presence of micropollutants in water samples. These assays provide scientists with a rapid, sensitive and cost-effective tool for evaluating the impact that environmental contaminants may have on biological activity.

Key Points: 
  • These assays provide scientists with a rapid, sensitive and cost-effective tool for evaluating the impact that environmental contaminants may have on biological activity.
  • However, the complexity of chemical mixtures in environmental matrices makes it difficult to choose which cellular response pathways to evaluate.
  • In this webinar, the featured speaker will review recent environmental toxicology research that employs an alternative workflow for evaluating water samples.
  • For more information, or to register for this event, visit Environmental Monitoring: Evaluating Cellular Response Pathways in Complex Mixtures .

ELISpot and FluoroSpot Assay Market Report 2022: Increasing Use of Elispot and Fluorospot Assays in Oncology Fuels Sector

Retrieved on: 
Thursday, December 1, 2022

Market is driven by factors such as increasing use of ELISpot and FluoroSpot assays in oncology, growth in biotechnology and biopharmaceutical industries.

Key Points: 
  • Market is driven by factors such as increasing use of ELISpot and FluoroSpot assays in oncology, growth in biotechnology and biopharmaceutical industries.
  • The Assay kits accounted for the largest market share in the ELISpot and FluoroSpot Assays product' market, during the forecast period
    The ELISpot and FluoroSpot Assay Products market is segmented into Assay kits, Analyzers, and Ancillary Products.
  • Based on type of application, the ELISpot and FluoroSpot Assays market is segmented into Diagnostic and Research Application.
  • The global ELISpot and FluoroSpot Assays market is divided into four regions: North America, Asia-Pacific, Europe, and Rest of the World.

ELISpot and FluoroSpot Assay Market Report 2022: Use of FluoroSpot Assays for Multiple-Analyte Detection in Single Well Presents Opportunities - ResearchAndMarkets.com

Retrieved on: 
Friday, November 25, 2022

Market is driven by factors such as Increasing use of ELISpot and FluoroSpot assays in oncology, growth in biotechnology and biopharmaceutical industries.

Key Points: 
  • Market is driven by factors such as Increasing use of ELISpot and FluoroSpot assays in oncology, growth in biotechnology and biopharmaceutical industries.
  • The Assay kits accounted for the largest market share in the ELISpot and FluoroSpot Assays product' market, during the forecast period
    The ELISpot and FluoroSpot Assay Products market is segmented into Assay kits, Analyzers, and Ancillary Products.
  • Based on type of application, the ELISpot and FluoroSpot Assays market is segmented into Diagnostic and Research Application.
  • The global ELISpot and FluoroSpot Assays market is divided into four regions: North America, Asia-Pacific, Europe, and Rest of the World.

INDIGO Biosciences Receives Approval from California Water Boards for Use of Its Bioassays in Recycled Water Monitoring

Retrieved on: 
Tuesday, November 15, 2022

STATE COLLEGE, Pa., Nov. 15, 2022  /PRNewswire-PRWeb/ -- INDIGO Biosciences, Inc. has received approval from the California Water Boards, State Water Resources Control Board, for the use of two of its bioassays in recycled water monitoring. INDIGO has been approved for the use of its Aryl Hydrocarbon Receptor (AhR) and Estrogen Receptor Alpha (ERα) bioassays as bioanalytical screening tools for Constituents of Emerging Concern (CECs) in recycled water.

Key Points: 
  • STATE COLLEGE, Pa., Nov. 15, 2022 /PRNewswire-PRWeb/ -- INDIGO Biosciences, Inc. has received approval from the California Water Boards, State Water Resources Control Board , for the use of two of its bioassays in recycled water monitoring.
  • INDIGO has been approved for the use of its Aryl Hydrocarbon Receptor (AhR) and Estrogen Receptor Alpha (ER) bioassays as bioanalytical screening tools for Constituents of Emerging Concern (CECs) in recycled water.
  • We look forward to developing additional bioassays that can help water boards and regulators everywhere monitor for contaminants that pose potential environmental and health risks."
  • As part of the approval process, INDIGO submitted validation packages for both its AhR and ER assays.

Enterome's OncoMimics™ peptide-based immunotherapy EO2401 generates and maintains elevated anti-tumor T cell responses for more than 10 months in patients with recurrent glioblastoma

Retrieved on: 
Thursday, November 10, 2022

PARIS, Nov. 10, 2022 /PRNewswire/ -- Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, today announces updated safety, immunogenicity and efficacy data of its Phase 1/2 clinical trial of EO2401 in combination with an immune checkpoint inhibitor (nivolumab) +/- an anti-VEGF therapy (bevacizumab), for the treatment of patients with first progression/recurrence of glioblastoma (ROSALIE trial). The data were presented in an oral and a poster presentation at the 37th Society for Immunotherapy of Cancer (SITC) Annual Meeting in Boston, MA, US, today.

Key Points: 
  • EO2401 includes synthetically produced HLA-A2 peptides with molecular mimicry to TAAs upregulated in glioblastoma (IL13Ra2, BIRC5 and FOXM1) and the CD4 helper peptide UCP2.
  • EO2401 in combination with nivolumab generated strong systemic immune responses through activation of specific effector memory CD8+ T cells, correlating with clinical efficacy.
  • Additional patients are to be treated with triple combination of EO2401 in combination with nivolumab and bevacizumab to support final regimen selection.
  • The trial is assessing safety, tolerability, immunogenicity and preliminary efficacy in approximately 80 patients at centers in the US and Europe.