Tecan has become one of the first companies to meet the requirements of the European Union’s In Vitro Diagnostic Regulation (IVDR) 2017/746 (Annex IX, Chapter I and III), successfully completing certification of its IBL International DHEA Saliva ELISA diagnostic assay kit through BSI Notified Body 2797. The valuable insights gained from this process will now be applied to the registration of Tecan’s complete portfolio of specialty IVD products – as well as to help its OEM partners ensure they are ‘IVDR ready’ – ahead of the May 2022 transition deadline.
The new IVDR is intended to increase the safety of all IVD products, including all innovations developed over the past decades. It represents a major regulatory overhaul, requiring reclassification and certification of all EU-registered IVD assays and devices. Introduced in 2017, it extends the scope of the outgoing IVDD to cover more devices and technologies – as well as supply chain and lifecycle management – and signifies a shift from a primarily ‘self-certification’ model to a requirement for notified body oversight. This greatly increases the regulatory burden for IVD manufacturers and notified bodies alike, making it essential to begin the certification process as soon as possible to avoid the risk of being forced out of EU markets.
Addressing the challenges of certification
Tecan is recognized as a global leader in quality and regulatory affairs (QARA), and is leading the sector in the management of the IVDD to IVDR transition. The company’s unique position as both an IVD and OEM manufacturer, combined with many years of expertise in IVD product registration globally, means that Tecan is ideally placed to address the challenges of certification for both its own products and those of its partners.
Guenter Weisshaar, Senior Vice President for QARA at Tecan, commented: “IVDR is a major business challenge for IVD manufacturers, requiring a significant investment of time and resources to ensure regulatory readiness. We are very pleased to be one of the first manufacturers to achieve product certification under the new regulations, and will be using our knowledge of this process to support and accelerate the certification of our IVD assays and devices, together with those of our OEM partners.”
Erica Conway, Global Head of IVD Medical Devices at BSI Notified Body 2797, added: “IVDR is a significant challenge to the in vitro diagnostic devices industry. It places greater regulatory requirements on everyone in the system, from manufacturers and notified bodies to importers and distributors. We are proud to continue to support our clients in the certification of devices under IVDR, ensuring that products remain available as we approach the May 2022 deadline.”
Tecan leads the way on IVDR certification
, /in E-News /by panglobalTecan has become one of the first companies to meet the requirements of the European Union’s In Vitro Diagnostic Regulation (IVDR) 2017/746 (Annex IX, Chapter I and III), successfully completing certification of its IBL International DHEA Saliva ELISA diagnostic assay kit through BSI Notified Body 2797. The valuable insights gained from this process will now be applied to the registration of Tecan’s complete portfolio of specialty IVD products – as well as to help its OEM partners ensure they are ‘IVDR ready’ – ahead of the May 2022 transition deadline.
The new IVDR is intended to increase the safety of all IVD products, including all innovations developed over the past decades. It represents a major regulatory overhaul, requiring reclassification and certification of all EU-registered IVD assays and devices. Introduced in 2017, it extends the scope of the outgoing IVDD to cover more devices and technologies – as well as supply chain and lifecycle management – and signifies a shift from a primarily ‘self-certification’ model to a requirement for notified body oversight. This greatly increases the regulatory burden for IVD manufacturers and notified bodies alike, making it essential to begin the certification process as soon as possible to avoid the risk of being forced out of EU markets.
Addressing the challenges of certification
Tecan is recognized as a global leader in quality and regulatory affairs (QARA), and is leading the sector in the management of the IVDD to IVDR transition. The company’s unique position as both an IVD and OEM manufacturer, combined with many years of expertise in IVD product registration globally, means that Tecan is ideally placed to address the challenges of certification for both its own products and those of its partners.
Guenter Weisshaar, Senior Vice President for QARA at Tecan, commented: “IVDR is a major business challenge for IVD manufacturers, requiring a significant investment of time and resources to ensure regulatory readiness. We are very pleased to be one of the first manufacturers to achieve product certification under the new regulations, and will be using our knowledge of this process to support and accelerate the certification of our IVD assays and devices, together with those of our OEM partners.”
Erica Conway, Global Head of IVD Medical Devices at BSI Notified Body 2797, added: “IVDR is a significant challenge to the in vitro diagnostic devices industry. It places greater regulatory requirements on everyone in the system, from manufacturers and notified bodies to importers and distributors. We are proud to continue to support our clients in the certification of devices under IVDR, ensuring that products remain available as we approach the May 2022 deadline.”
BBI Solutions launches two new SARS-Cov-2 antigens as raw materials for IVD manufacturers
, /in Product News /by panglobalBBI’s recently-acquired and well-respected team based in Freiburg, Germany (DIARECT GmbH) has developed two new recombinant antigen preparations produced in Baculovirus transfected Sf9 cells.
The antigens Nucleocapsid (N) protein and Spike (S) glycoprotein Receptor Binding Domain (RBD) have been designed as critical raw materials for next generation serological assays.
With the continuing COVID-19 vaccination programme, testing for antibody response will become increasingly important. Antibody tests detecting immune response to both the conserved and abundant nucleocapsid and the receptor binding domain that is unique for the SARS-CoV-2, will deliver physicians important information for disease management.
Serology testing is strongly suggested to play a major role in screening populations to determine exposure, as well as potential immunity, to identify recovering individuals as plasma donors as well as for research on immune response and to help identify neutralising antibodies (Amanat et al. 2020; Farnsworth and Anderson 2020; Okba et al. 2020).
Seven manufacturing sites across four continents
BBI Solutions has seven manufacturing sites across four continents and has an established reputation as a leading manufacturer of biological reagents and finished test platforms for the in-vitro diagnostics market. The lateral flow manufacturing centre of excellence in Wales, UK is also part of the UK-Rapid Test Consortium (UK-RTC).
BBI Solutions acquired the Germany-based specialist manufacturer of autoimmune, infectious disease and allergy antigens DIARECT last year. This launch is the latest of new products in the pipeline. BBI’s two novel antigens are produced and characterised in the company’s ISO 13485:2016 compliant laboratories in Freiburg, Germany.
Dr Mario Gualano, Chief Executive of BBI Group, said: “These recombinant antigens are a welcome addition to our product catalogue and complement our existing range. We were delighted that our expertise in Freiburg can add a further component to the support BBI can offer the IVD industry in the fight against this pandemic.”
KLoneus® Free Light Chain (FLC) assays, for Turdidimetry and Nephelometry
, /in Product News /by 3wmediaTRIMERO Diagnostics offers, under the brand KLoneus®, IVD CE marked nephelometric assays for testing FREE LIGHT CHAINS (FLC) on Beckman Coulter’s IMMAGE® Immunochemical Systems and Siemens’ BN™ nephelometric systems.
Optimised Microplates for Affinity Binding Assays
, /in Product News /by 3wmediaMedium and high bind Krystal microplates from Porvair Sciences set a new standard for uniform and reproducible capture of a wide range of biomolecules ready for affinity binding assays such as Enzyme-Linked Immunosorbent Assay (ELISA). Manufactured from high-quality crystal polystyrene – these new automation-ready plates are available in a choice of ANSI / SLAS standard (96-well […]
Greiner Bio-One introduces VACUETTE FC Mix Tube for effective glycolysis inhibition
, /in Product News /by callanGreiner Bio-One has introduced VACUETTE FC Mix Tube for effective glycolysis inhibition for precise determination of the in vivo blood sugar content.
The time from collection until separation of plasma and cells, temperature as well as cell count strongly affect glucose levels possibly leading to false low results. Unfortunately, fluoride alone is not able to stabilize the real in-vivo glucose level completely.
VACUETTE FC Mix Tubes are citrated and therefore can help to prevent the initial loss of glucose within the first few hours from collection until fluoride shows its effect. Buffered Na2EDTA, citric acid, sodium citrate and sodium fluoride are used to decrease the pH and block the pH dependent enzymes, which would be active in the initial stage of the glycolysis cascade.
SEKISUI Diagnostics launches OSOM Ultra Plus Flu A&B Test
, /in Product News /by callanSEKISUI Diagnostics has launched the OSOM Ultra Plus Flu A&B Test. The test utilizes traditional lateral flow technology with performance near or exceeding sensitivity of other reader-based tests without using an instrument. It is intended for the qualitative detection of influenza type A and type B nucleoprotein antigens directly from nasal or nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection.
High performance, point-of-care rapid test for the detection of Influenza A&B
IgD Immunoglobulin assays for nephelometry (IMMAGE® and BN™ series) and turbidimetry
, /in Product News /by TRIMERO DIAGNOSTICSTRIMERO Diagnostics offers IVD CE marked assays for testing IgD Immunoglobulins (IgD) on Beckman Coulter’s IMMAGE® Immunochemical Systems and Siemens’ BN™ nephelometric systems.
ERBA Mannheim launches 2nd generation SARS-CoV-2 RT-PCR Assay with room temperature storage
, /in Product News, Corona News /by callanIn response to the ongoing COVID-19 pandemic, Erba Mannheim has launched the ErbaMDx SARS-CoV-2 RT-PCR Kit for detection of SARS-CoV-2.
To overcome challenges in older COVID-19 molecular tests, Erba’s Cambridge(UK)-based development team has engineered a new assay to improve detection and ease of use with a single tube multiplex mastermix, compatible with room-temperature storage and transportation.
The new assay offers 200 copies/ml LoD, using universally trusted gene targets highly specific for SARS-CoV-2 and updated primer sequences to maximise long term performance. Sample types include both nasopharyngeal and oropharyngeal swabs as well as saliva.
Nikhil Vazirani, MD of Erba, said: “We are proud and excited to add a highly sensitive RT-PCR test to our growing range of immunoassay and molecular solutions. The new ErbaMDx SARS-CoV-2 test perfectly complements our successful COVID-19 IgG and IgM ELISA assays to offer customers a state-of-the-art molecular test in addition to antibody testing which will offer clinicians valuable insight into the immune response to infection or vaccination.”
The CE-marked kit will be available through Erba’s global distribution network.
Erba Mannheim, established in over 100 countries, focusses on delivering innovative, affordable and sustainable diagnostic solutions to labs everywhere. The Erba group uses a combination of cutting-edge R&D in 4 continents with efficient low-cost manufacturing to make diagnostic technologies accessible in all resource settings.
IVD Test and Product Development
, /in Advertenties /by 3wmediaBasic Metabolic Panel. STAT.
, /in Advertenties /by 3wmedia