Latest news with #Mechelen
Yahoo
3 days ago
- Business
- Yahoo
Press Release Biocartis NV: Biocartis Announces IVDR Class C CDx Certification of the Idylla™ EGFR Mutation Test
PRESS RELEASE 02/06/2025, 10:00 CEST Biocartis Announces IVDR Class C CDx Certification of the Idylla™ EGFR Mutation Test Mechelen, Belgium, 02 June 2025 – Biocartis NV ('Biocartis'), an innovative molecular diagnostics company, is pleased to announce that its Idylla™ EGFR Mutation Test has received the European Union (EU) Technical Documentation Assessment and Quality Management System certificate under the European In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR), making it the first Idylla™ Test to be certified as a Class C Companion Diagnostic (CDx) IVD Medical Device under the IVDR framework. The IVDR-certified Idylla™ EGFR Mutation Test is designed to serve as a CDx for the detection of EGFR exon 19 deletions and the L858R mutation, which are key biomarkers that guide targeted therapies for patients with non-small cell lung cancer (NSCLC). The IVDR certification confirms the Test's compliance with Europe's rigorous new regulatory standards, ensuring enhanced patient safety, improved information transparency, and robust data traceability. Designed for use on the Idylla™ Platform, the Test qualitatively detects 44 mutations across exons 18, 19, 20, and 21 of the EGFR gene – all within a single cartridge. Among these, exon 19 deletions and L858R mutations are validated as CDx targets, and the remaining mutations have been analytically validated. Utilizing formalin-fixed, paraffin-embedded (FFPE) tissue samples, the Test is fully automated from sample to result, delivering fast results in under 3 hours – streamlining laboratory workflows and empowering oncologists with timely treatment decisions for their patients. With 99.2% sensitivity (PPA) and 99.0% specificity (NPA) for the CDx targets, the Idylla™ EGFR Mutation Test ensures accurate detection of key EGFR mutations, providing healthcare professionals with actionable results to guide treatment decisions in NSCLC. For more information about the Test, please visit the Biocartis website or contact the Biocartis team. While the IVDR-certified Idylla™ EGFR Mutation Test is now available to customers across Europe, with availability in other non-US markets expected to follow progressively – Biocartis is also developing the Idylla™ EGFR CDx Test in the US with AstraZeneca. Upon approval, the Test will be intended to help identify patients with NSCLC who may respond to treatment with Tagrisso® (Osimertinib), AstraZeneca's third-generation EGFR-TKI treatment. Roger Moody, Chief Executive Officer of Biocartis, commented: 'Achieving IVDR certification for our Idylla™ EGFR Mutation Test is a key milestone for Biocartis and reinforces our commitment to quality and regulatory excellence. This is the first Idylla™ Test to be certified under the new IVDR framework, and we are currently pursuing certification of additional Tests in our portfolio. The IVDR establishes more rigorous standards to improve patient safety and diagnostic accuracy, and we are proud to be at the forefront of this evolution in European diagnostics.' ----- END ----- More information: info@ Biocartis NV. Generaal De Wittelaan 11B, 2800 Mechelen, Belgium About Biocartis With its revolutionary and proprietary Idylla™ Platform, Biocartis aspires to enable personalized medicine for patients around the world through universal access to molecular testing, by making molecular testing actionable, easy, fast and suitable for any lab. The Idylla™ Platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) based system designed to offer in-house molecular biomarker testing in only 3 hours, allowing fast and optimal treatment selection. Idylla™'s continuously expanding menu of molecular diagnostic tests and research assays addresses key unmet clinical needs. Today, Biocartis offers tests supporting lung, skin, thyroid, colorectal, endometrial, blood, brain and breast cancer. More information: Follow us on LinkedIn, Facebook and X (Twitter). Disclaimers Idylla™ Platform is CE-marked in Europe in compliance with EU IVD Regulation 2017/746, listed as a class II device in the US under establishment registration 3009972873, and registered in many other countries. Idylla™ EGFR Mutation Test (A0270/6) is CE-marked in Europe in compliance with the EU IVD Regulation 2017/746 (IVDR). Biocartis and Idylla™ are registered trademarks in Europe, the US and many other countries. The Biocartis and Idylla™ trademarks and logos are used trademarks owned by Biocartis NV. © June 2025, Biocartis NV. All rights lors de la récupération des données Connectez-vous pour accéder à votre portefeuille Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données
Glasgow Times
3 days ago
- Sport
- Glasgow Times
Celtic's Stephen Welsh targeted by KV Mechelen after loan
The centre-back, 25, moved to Belgium on loan in January with game time at a premium during the first part of the season. Mechelen had an offer rejected for him last summer but persisted in the winter window and landed their man. Welsh played 17 times for the Jupiler Pro League as they made it to the Conference League play-off group of the Belgian league split, although they ultimately failed to qualify for Europe. He is due to return for Hoops pre-season but has impressed his loan club enough that they are looking to try and sign him permanently, reports the Daily Record. However, his performances have also caught the eye of other clubs and they face competition from within Belgium and also other European clubs. The defender scored his first goal for Mechelen against FCV Dender at the weekend. Previously speaking on his spell, he said: 'I have loved every minute of it. 'I think it is the best thing I have done, it is almost like a refresh for six months to go and play football at a top level.' Welsh has two years left on his contract but found Cameron Carter-Vickers, Auston Trusty, Liam Scales and Maik Nawrocki ahead of him in the pecking order before heading out in january.
The National
27-05-2025
- Sport
- The National
Celtic's Stephen Welsh targeted by KV Mechelen after loan
The centre-back, 25, moved to Belgium on loan in January with game time at a premium during the first part of the season. Mechelen had an offer rejected for him last summer but persisted in the winter window and landed their man. Welsh played 17 times for the Jupiler Pro League as they made it to the Conference League play-off group of the Belgian league split, although they ultimately failed to qualify for Europe. He is due to return for Hoops pre-season but has impressed his loan club enough that they are looking to try and sign him permanently, reports the Daily Record. However, his performances have also caught the eye of other clubs and they face competition from within Belgium and also other European clubs. The defender scored his first goal for Mechelen against FCV Dender at the weekend. Previously speaking on his spell, he said: 'I have loved every minute of it. 'I think it is the best thing I have done, it is almost like a refresh for six months to go and play football at a top level.' Welsh has two years left on his contract but found Cameron Carter-Vickers, Auston Trusty, Liam Scales and Maik Nawrocki ahead of him in the pecking order before heading out in january.
Daily Record
27-05-2025
- Sport
- Daily Record
Stephen Welsh wanted for permanent Celtic transfer exit as club make signing top priority
Brendan Rodgers already has Cameron Carter-Vickers, Auston Trusty, Liam Scales and Maik Nawrocki at centre-back K.V. Mechelen want to sign Celtic's Stephen Welsh on a permanent basis. The central defender has just ended a successful loan with the Belgian Pro League outfit. Welsh is due to return to the Scottish champions for pre-season. Mechelen sporting director Dennis Henderickx has indicated that getting Welsh back to the club is a major priority. He helped the Belgian's into the European play-offs after he made the move in January. His success with Mechelen hasn't gone unnoticed with other Belgian and European clubs also keen a close eye on the situation. The 25-year-old, who scored his first goal for Mechelen in his final appearance against FCV Dender at the weekend, has got a regular taste of first-team football he craved. Welsh made 19 appearances for Mechelen and was keen to put a run of games together after spending large spells of the first half of the season on the bench or in the stands at Celtic. Welsh, in a previous interview with the Daily Record, said: Welsh stated: 'I have loved every minute of it. 'I think it is the best thing I have done, it is almost like a refresh for six months to go and play football at a top level.' The centre half still has two years left on his Celtic contract. A lot will depend on where Brendan Rodgers' sees Welsh in his plans. Rodgers has Cameron Carter-Vickers, Auston Trusty, Liam Scales and Maik Nawrocki for the centre half positions just now. You can get all the news you need on our dedicated Rangers and Celtic pages, and sign up to our newsletters to make sure you never miss a beat throughout the season. We're also WhatsApp where we bring all the latest breaking news and transfer gossip directly to you phone. Join our Rangers community here and our Celtic community here.
Daily Record
27-05-2025
- Sport
- Daily Record
Kyogo offered Celtic reunion as Premier League transfer escape route emerges and loan Bhoy wanted permanently
The striker has endured a miserable stint in France following his Parkhead exit last January English Premier League side Bournemouth reportedly want to bring Kyogo 's nightmare spell at Rennes to an end. The Celtic hero only joined the Ligue 1 outfit in a £10million switch back in January but made just six cameo appearances in the second half of the season, failing to score in any of them. Reports in France claim that the frontman is set for a quickfire exit in the summer and Le Parisien now claim that the 30-year-old is on the Cherries' radar. Should he make the move to the Vitality Stadium, then he would be reunited with former Parkhead teammate Ryan Christie. Bournemouth will have cash to burn this summer after selling star defender Dean Huijsen to Real Madrid for £50m. Elsewhere, Record Sport can exclusively reveal that K.V. Mechelen want to sign Celtic's Stephen Welsh on a permanent basis. The central defender has just ended a successful loan with the Belgian Pro League outfit. Welsh is due to return to the Scottish champions for pre-season. Mechelen sporting director Dennis Henderickx has indicated that getting Welsh back to the club is a major priority. He helped the Belgians into the European play-offs after he made the move in January. His success with Mechelen hasn't gone unnoticed with other Belgian and European clubs also keen a close eye on the situation. The 25-year-old, who scored his first goal for Mechelen in his final appearance against FCV Dender at the weekend, has got a regular taste of first-team football he craved. Welsh made 19 appearances for Mechelen and was keen to put a run of games together after spending large spells of the first half of the season on the bench or in the stands at Celtic. Welsh, in a previous interview with Record Sport, said: Welsh stated: 'I have loved every minute of it. 'I think it is the best thing I have done, it is almost like a refresh for six months to go and play football at a top level." The centre half still has two years left on his Celtic contract. A lot will depend on where Brendan Rodgers sees Welsh in his plans. Rodgers has Cameron Carter-Vickers, Auston Trusty, Liam Scales and Maik Nawrocki for the centre half positions just now. The Premiership champions have been left reeling from last weekend's shock Scottish Cup final defeat to Aberdeen that denied them a domestic Treble and Rodgers has reiterated his desire to strengthen the squad this summer. Links with Brondby attacker Mathias Kvistgaarden won't go away after the Danish frontman was called up at senior level for his country for the first time. The 23-year-old netted 17 goals in just 26 league starts for his club this season and has been included in Brian Riemer's squad for the first time ahead of the friendly double-header against Northern Ireland and Lithuania next month. And national boss Riemer believes the Denmark newboy has the ability to 'torment' opposition defenders. He said: "He could have been called up sooner, but he had a couple of injury setbacks. "Kvistgaarden hit really good form at the end of the season, so it was natural he was selected. In almost all the matches I've seen Kvistgaarden play, he's been a tormentor for the opponents' defences. "He really gets a lot out of a little. He is a guy who believes in even the most impossible chance. He is willing to run with and without the ball. So I look forward to seeing him in camp." And Kvitsgaarden himself was ecscatic to hear the phone ring. He said: "I'm incredibly proud to have been selected for the Denmark team. "It's huge for me and it's the opportunity to represent my country was something I never thought would happen during my time here." Tune in to Hotline Live every Sunday to Thursday and have your say on the biggest issues in Scottish football and listen to Record Sport's newest podcast, Game On, every Friday for your sporting fix, all in bitesize chunks.
