This study is a prospective accuracy observational study to evaluate the performance of the Highplex System SARS-Cov-2, Influenza and RSV 8-well in vitro diagnostic medical device panel and generate performance data. The precision of results will be evaluated in concordance with the comparator predicate device panel BioFire Respiratory Panel 2.1 (RP2.1).

开始日期2023-07-01

申办/合作机构

AusDiagnostics Pty Ltd.

DRKS00027129 / RecruitingN/A

Collection of blood samples for the evaluation of the analytical performance of two new in vitro test systems for tuberculosis diagnostics - TID-2

开始日期2022-05-17

申办/合作机构

R-Biopharm AG

100 项与 R-Biopharm AG 相关的临床结果

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项与 R-Biopharm AG 相关的文献（医药）

2022-09-06·Journal of AOAC International4区 · 农林科学

Analysis of Aflatoxins, Fumonisins, Deoxynivalenol, Ochratoxin A, Zearalenone, HT-2, and T-2 Toxins in Animal Feed by LC–MS/MS Using Cleanup with a Multi-Antibody Immunoaffinity Column

4区 · 农林科学

Article

作者: Mackay, Naomi ; Leeman, Dave ; Marley, Elaine ; Donnelly, Carol ; Poplawski, Cezary

Abstract:

Background:

Regulations limiting aflatoxin levels in animal feed and guidance values for maximum levels for fumonisins (FB1 and FB2), deoxynivalenol (DON), ochratoxin A (OTA), zearalenone (ZON), HT-2, and T-2 toxins are in place both to protect animal health and to minimize potential transfer to animal products for human consumption. A multi-mycotoxin method which can handle complex feed matrices such as distillers dried grains with solubles (DDGS) is essential for analysis and accurate quantification without the need to revert to separately analyze individual mycotoxins.

Objective:

The objective of this study is to generate single laboratory validation data for a method employing a multi-antibody immunoaffinity column (IAC) capable of providing cleanup for eleven mycotoxins, followed by LC–MS/MS quantification without the need for isotopic labelled and matrix-matched standards. The applicability of method is to be demonstrated for corn feed, pig feed, and DDGS by fortification and naturally occurring mycotoxins covering the range of regulated limits.

Methods:

Feed sample (1 kg) ground by milling to approximately 1–2 mm particle size and sub-sample (5 g) extracted with acetonitrile–water–formic acid, passing through a multi-mycotoxin IAC, washing, and eluting prior to LC–MS/MS analysis monitoring selected ion transitions.

Results:

Recoveries were in the range 74 to 117% (excluding five outliers) for aflatoxins, FB1, FB2, DON, OTA, ZON, HT-2, and T2- toxins spiked into three commercial animal feed matrixes (n = 84) and within-day RSDs averaged 1.7 to 10.3% (n = 99).

Conclusion:

Single laboratory validation of a multi-antibody IAC method coupled with LC–MS/MS has shown the method to be suitable for accurate quantification of eleven regulated mycotoxins in DDGS, pig feed, and poultry feed.

Highlights:

IAC method capable of accurately quantifying eleven regulated mycotoxins in complex feed matrices.

2021-06-12·Journal of AOAC International4区 · 农林科学

Determination of Aflatoxin M1 in Liquid Milk, Cheese, and Selected Milk Proteins by Automated Online Immunoaffinity Cleanup with Liquid Chromatography‒Fluorescence Detection

4区 · 农林科学

Article

作者: Pazdanska, Monika ; Rhemrev, Ria ; Gill, Brendon D ; Marley, Elaine ; Mackay, Naomi ; Wood, Jackie E ; Indyk, Harvey E

Abstract:

Background:

Aflatoxins are secondary metabolites produced by a number of species of Aspergillus fungi. Aflatoxin M1 (AFM1) is a hydroxylated metabolite of aflatoxin B1 and is found in the milk of cows fed with feed spoilt by Aspergillus species. AFM1 is carcinogenic, especially in the liver and kidneys, and mutagenic, and is also an immunosuppressant in humans.

Objective:

A high-throughput method for the quantitative analysis of AFM1 that is applicable to liquid milk, cheese, milk protein concentrate (MPC), whey protein concentrate (WPC), whey protein isolate (WPI), and whey powder (WP) was developed and validated.

Method:

AFM1 in cheese, milk, and protein products is extracted using 1% acetic acid in acetonitrile with citrate salts. The AFM1 in the resulting extract is concentrated using RIDA®CREST/IMMUNOPREP® ONLINE cartridges followed by quantification by HPLC‒fluorescence.

Results:

The method was shown to be accurate for WP, WPC, WPI, MPC, liquid milk, and cheese, with acceptable recovery (81–112%) from spiked samples. Acceptable precision for WP, WPC, WPI, MPC, liquid milk, and cheese was confirmed, with repeatabilities of 4–12% RSD and intermediate precisions of 5–13% RSD. Method detection limit and ruggedness experiments further demonstrated the suitability of this method for routine compliance testing. An international proficiency scheme (FAPAS) cheese sample showed that this method gave results that were comparable with those from other methods.

Conclusions:

A method for high-throughput, routine testing of AFM1 is described. The method was subjected to single-laboratory validation and was found to be accurate, precise, and fit-for-purpose.

Highlights:

An automated online immunoaffinity cleanup HPLC‒fluorescence method for milk proteins, cheese, and milk was developed and single-laboratory validated. It allows for high-throughput analysis of AFM1 and can be used for the analysis of AFM1 in whey protein products.

2020-12-01·Pathology

Rapid deployment of pathology services to a remote Australian quarantine setting during the COVID-19 pandemic

Letter

作者: Poljak, Marin ; Stephens, Dianne ; Polkinghorne, Adam ; Branley, James ; O'Sullivan, Matthew

In early Feb.2020, like other nations, the Australian government launched a mission to retrieve Australian citizens from Wuhan, China, caught up in the travel restrictions imposed in the Hubei province.The mission retrieved 278 Australian citizens to Christmas Island, Australia, to undergo quarantine for 14 days.Christmas Island is an Australian external ter-ritory situated in the Indian Ocean, 1500 km west of the Australian mainland.Evacuees were housed in a government facility with essential health care capability for the duration of the quarantine period.The evacuees remained on Christmas Island for a 14 day quarantine period, prior to return by air to the Australian mainland.In this correspondence we highlight the ability to implement advanced testing in a remote environment.

项与 R-Biopharm AG 相关的新闻（医药）

2023-10-25

·PRNewswire

PCR System for Food Diagnostics Market size to grow by USD 977.11 million from 2021 to 2026, North America to account for 41% of market growth- Technavio

NEW YORK, Oct. 25, 2023 /PRNewswire/ -- The PCR system for food diagnostics market is expected to grow by USD 977.11 million from 2021 to 2026. In addition, the momentum of the market will progress at a CAGR of 8.31% during the forecast period, according to Technavio Research. The market has been segmented by Product (consumables and instruments) and Geography (North America, Europe, Asia, and the Rest of the World (ROW)). 41% of the market's growth will originate from North America during the forecast period. The US and Canada are the key markets in the region. The presence of several regulatory organizations in the countries will facilitate market growth. This report offers an up-to-date analysis of the current market scenario, the latest trends and drivers, and the overall market environment. Read PDF Sample Report Continue Reading Technavio has announced its latest market research report titled Global PCR System for Food Diagnostics Market 2022-2026 Company Profile: Agilent Technologies Inc., Bio Rad Laboratories Inc., bioMerieux SA, BIOTECON Diagnostics GmbH, F. Hoffmann La Roche Ltd., Generon SpA, Genesystem, Hygiena LLC, Lumex Instruments, LuminUltra Technologies Ltd, Merck and Co. Inc., Microsynth AG, Minerva Biolabs GmbH, Molbio Diagnostics Pvt. Ltd., Mylab Discovery Solutions Pvt Ltd., QIAGEN NV, QuantuMDx Group Ltd., R Biopharm AG, SAN Group GmbH, Xiamen Zeesan Biotech Co. Ltd, and Thermo Fisher Scientific Inc. Agilent Technologies Inc. - The company offers Maxi pads that are biodegradable, chemical-free, and colorful with hooks at the end of the wings to attach to the garment. To gain access to more company profiles available with Technavio, buy the report! PCR System For Food Diagnostics Market: Segmentation Analysis The market share growth by the consumables segment will be significant during the forecast period. Assays, probes, reagents, and kits are included in consumables. Learn about the contribution of each segment summarized in concise infographics and thorough descriptions. View a PDF Sample Report "Besides analyzing the current market scenario, our report examines historic data from 2017 to 2021"- Technavio PCR System For Food Diagnostics Market: Driver & Trend: Rising foodborne illnesses Organizations advocating food safety globally Increasing food safety regulations globally The rising number of foodborne illnesses is a key factor driving market growth. Most of the foodstuffs consumed are mainly plant or animal-based foods and usually have a wide variety of bacterial species in them. Consequently, companies are focused on minimizing financial losses when unsafe or potentially deadly food products are introduced into the market. Increasing consumer awareness about food safety is a major trend in the market. Identify key trends, drivers, and challenges in the market. Download to gain access to this information. Related Reports: The Food Safety Testing Market is estimated to grow by USD 9,209.62 million between 2022 and 2027 accelerating at a CAGR of 7.84% during the forecast period. The laboratory water purifier market is estimated to grow at a CAGR of 6.86% between 2022 and 2027. The market size is forecast to increase by USD 7,663.32 million. What are the key data covered in this PCR system for Food Diagnostics Market Report? CAGR of the market during the forecast period Detailed information on factors that will drive the growth of the PCR system for food diagnostics market between 2021 and 2026. Precise estimation of the PCR system for food diagnostics market size and its contribution to the market in focus on the parent market Accurate predictions about upcoming trends and changes in consumer behavior Growth of the PCR system for food diagnostics market in North America, Europe, Asia, and ROW A thorough analysis of the market's competitive landscape and detailed information about companies Comprehensive analysis of factors that will challenge the growth of PCR system for food diagnostics market companies. ToC: Executive Summary Market Landscape Market Sizing Historic Market Sizes Five Forces Analysis Market Segmentation by Product Market Segmentation by Geography Customer Landscape Geographic Landscape Drivers, Challenges, & Trends Company Landscape Company Analysis Appendix About Technavio Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provide actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios. Contacts Technavio Research Jesse Maida Media & Marketing Executive US: +1 844 364 1100 UK: +44 203 893 3200 Email: [email protected] Website: SOURCE Technavio

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2023-07-20

·BioSpace

leon-nanodrugs appoints Dr. Hans Frickel as Chief Executive Officer

July 18, 2023 – Munich (Germany) – leon-nanodrugs GmbH (“LEON”), the leading enabler of nano technology for the pharmaceutical industry, announced today the appointment of Dr. Hans Frickel as CEO, effective July 1, 2023. Dr. Hans Frickel, a trained pharmacist and industrial manager, brings more than 20 years of experience in strategic and operational leadership roles across the entire value chain of pharmaceuticals and medical devices. Prior to joining LEON, he served as Managing Director at R‑Biopharm and held several senior operational management roles at BioNTech, Evonik, Midas Pharma, Procter & Gamble and Merck. Dr. Hubert Birner, Chairman of the LEON Supervisory Board, said: “On behalf of the Supervisory Board, I am delighted to welcome Dr. Hans Frickel to LEON. With his extensive expertise in different areas of modern drug manufacturing, including plant management and QC, as well as a strong track record in strategy and governance, he is an ideal fit to take LEON to the next stage. On behalf of the Supervisory Board I also would like to thank our interim CEO and CFO Christian Nafe, our CSO Dr. Setu Kasera and their team for their tremendous work in driving our technology towards commercialization and for the great progress that has been achieved to date.” “I am excited to join LEON as we work to transform nanomedicine manufacturing,” said Dr. Hans Frickel, CEO of LEON. “I am impressed with the team’s knowledge and dedication in working to create added value across the nano formulation processing chain. I truly believe that LEON’s NANO devices will significantly improve development and manufacturing for current and future standardized and personalized cell & gene therapies at CDMOs, biotech and pharma companies.” ABOUT LEON-NANODRUGS leon-nanodrugs GmbH (“LEON”) is a pharmatech company specializing in the development and marketing of devices for the encapsulation of genetic material and other active substances into nanodrug carriers, such as lipid nanoparticles (LNPs). The Munich-based private company builds its innovative solutions based on its proprietary FR-JET Technology, enabling pharma companies and small biotechs as well as CDMOs to optimize nanomedicine manufacturing and take full advantage of the significant progress being made in advanced therapies. LEON's GMP-compliant, aseptic devices NANOme and NANOus increase efficiency in the production of nano drug carriers and are suitable for both clinical-scale and commercial production. In addition to its product offering, LEON will provide in-house lab capacity for process development with its own devices. For further information, please visit and follow us on LinkedIn and Twitter. CONTACT: MEDIA INQUIRIES: leon-nanodrugs GmbH Maja Tinko-Kuhar, Marketing Manager Phone: +49-89-41424889-98 e-mail: m.tinko-kuhar@leon-nanodrugs.com MC Services AG Katja Arnold / Eva Bauer Phone: +49-89-210228-0 e-mail: leon-nanodrugs@mc-services.eu Dr. Hans Frickel, CEO of leon-nanodrugs GmbH, © LEON For a high-res picture please contact leon-nanodrugs@mc-services.eu.

高管变更

2023-07-05

·GlobeNewswire-Health Care

Microbix QAPs Supporting HPV Testing Across The Netherlands

Distribution Partner Secures Contract Relating to Cervical Cancer ScreeningMISSISSAUGA, Ontario, July 05, 2023 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that its quality assessment products (“QAPs™”) have been selected to support a screening program for Human Papilloma Virus (“HPV”) using molecular diagnostic (“MDx”) technology across The Netherlands, an EU member-state. Microbix’s local distribution partner, R-Biopharm, has secured a tendered contract to supply goods and services to support this national-level HPV-based cervical cancer screening program. The program is being driven by the instrumentation and reagents of the BD COR™ system and its Onclarity™ HPV assay. Microbix REDx® liquid-format IVD-regulated QAPs will be used to support the quality management system monitoring the ongoing accuracy of laboratory performance for the program. The program will invite women between the ages of 30 to 60 within the Dutch population of approximately 17.8 million. HPV is a family of over 100 virus sub-types, 14 of which are deemed “high-risk” as they may cause cancers, most notably cervical cancer, if not resolved by the immune system. Most sexually-active adults become infected with one or more HPV types and such infections can be persistent. MDx tests permit early detection and timely preventative healthcare by identifying those at-risk years before cancer develops. However, MDx-based screening programs require rigorous quality systems and ongoing monitoring of test accuracy, in particular when performed in multiple laboratories and using multiple equipment lines. This includes creating workflow algorithms, implementing strict QC/QA practices, training staff to be proficient, and sourcing materials and methods to evaluate testing workflows. Microbix’s portfolio of HPV-directed QAPs are used to help ensure the ongoing accuracy of MDx testing. Dr. Andreas Simons, Director, Project Management Clinical Diagnostics of R-Biopharm stated, “It’s a pleasure to support this important women’s health initiative of the Dutch national screening agency, Bevolkingsonderzoek Nederland. The next contract period of this primary cervical cancer screening program is now beginning, with its quality management supported by R-Biopharm and Microbix’s QAPs.” An initial order for HPV-directed QAPs has been shipped by Microbix and it is expected that its QAPs sales under this tender contract will reach several hundred thousand Canadian Dollars. Microbix and its distribution partners are likewise targeting to support MDx and HPV-based cervical cancer screening programs in other countries across the EU and in North America. Dr. Rob Schuurman, National Reference Officer for the Dutch Cervical Cancer Screening Program (BVO), noted “MDx testing for HPV improves cervical cancer screening by identifying those at-risk efficiently. Close monitoring of the entire HPV testing workflow is critical to realizing this healthcare goal and Microbix’s HPV QAPs have been selected to support the quality assessment monitoring of the molecular testing process, a vital part of BVO’s quality management system.” About Microbix BiosystemsMicrobix creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, Neo-Science Equipment LLC, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products. Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada. Forward-Looking InformationThis news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of any customer or distributor herein, or any MDx-based screening programs, MDx testing for HPV or its relevance, the products or services of Microbix, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital or raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information. Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings. For further information, please contact Microbix at: Cameron Groome, CEO(905) 361-8910Jim Currie,CFO(905) 361-8910Deborah Honig,Investor RelationsAdelaide Capital Markets(647) 203-8793ir@microbix.com Copyright © 2023 Microbix Biosystems Inc. Microbix®, DxTM™, Kinlytic®, QAPs™, and REDx™ are trademarks of Microbix Biosystems Inc.COR™ and Onclarity™ are trademarks of Becton, Dickinson and Company

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