Labcorp Achieves IVDR CE-Marking for PGDx elio™ tissue complete in the EU
Labcorp (NYSE: LH) has achieved IVDR CE-marking for its PGDx elio tissue complete test in the European Union, making it the first and only test of its kind approved for comprehensive solid tumor profiling under new EU regulations. The test, which already has FDA clearance in the US, will help diagnose and treat approximately 2.7 million people diagnosed with cancer annually in the EU.
The in vitro diagnostic assay can analyze multiple biomarkers simultaneously, even with limited tissue samples, enabling faster and more effective patient management plans. The test will be available through Labcorp's central laboratory in Geneva, Switzerland, supporting both biopharma partners and investigational use in global clinical trials.
Labcorp (NYSE: LH) ha ottenuto la marcatura CE IVDR per il suo test PGDx elio tissue complete nell'Unione Europea, diventando il primo e unico test di questo tipo approvato per il profilo completo dei tumori solidi secondo le nuove normative UE. Il test, già autorizzato dalla FDA negli Stati Uniti, contribuirà alla diagnosi e al trattamento di circa 2,7 milioni di persone diagnosticate con il cancro ogni anno nell'UE.
Questo test diagnostico in vitro è in grado di analizzare simultaneamente più biomarcatori, anche con campioni di tessuto limitati, permettendo piani di gestione del paziente più rapidi ed efficaci. Il test sarà disponibile presso il laboratorio centrale di Labcorp a Ginevra, Svizzera, supportando sia i partner biofarmaceutici sia l'uso investigativo in studi clinici globali.
Labcorp (NYSE: LH) ha obtenido la marcación CE IVDR para su prueba PGDx elio tissue complete en la Unión Europea, convirtiéndola en la primera y única prueba de este tipo aprobada para el perfil completo de tumores sólidos bajo las nuevas regulaciones de la UE. La prueba, que ya cuenta con la aprobación de la FDA en EE.UU., ayudará a diagnosticar y tratar a aproximadamente 2,7 millones de personas diagnosticadas con cáncer anualmente en la UE.
El ensayo diagnóstico in vitro puede analizar múltiples biomarcadores simultáneamente, incluso con muestras limitadas de tejido, lo que permite planes de manejo del paciente más rápidos y efectivos. La prueba estará disponible a través del laboratorio central de Labcorp en Ginebra, Suiza, apoyando tanto a socios biofarmacéuticos como a usos investigativos en ensayos clínicos globales.
Labcorp (NYSE: LH)는 유럽 연합에서 PGDx elio tissue complete 검사에 대해 IVDR CE 인증을 획득하여 새로운 EU 규정 하에 종합적인 고형암 프로파일링을 승인받은 최초이자 유일한 검사로 자리매김했습니다. 이 검사는 이미 미국에서 FDA 승인을 받았으며, EU 내 매년 약 270만 명의 암 환자 진단 및 치료에 도움을 줄 것입니다.
이 체외 진단 검사법은 제한된 조직 샘플로도 여러 바이오마커를 동시에 분석할 수 있어 더 빠르고 효과적인 환자 관리 계획을 가능하게 합니다. 이 검사는 스위스 제네바에 위치한 Labcorp 중앙 연구소를 통해 제공되며, 바이오제약 파트너와 전 세계 임상 시험에서의 연구용으로 지원됩니다.
Labcorp (NYSE: LH) a obtenu le marquage CE IVDR pour son test PGDx elio tissue complete dans l'Union européenne, devenant ainsi le premier et unique test de ce type approuvé pour le profilage complet des tumeurs solides selon les nouvelles réglementations de l'UE. Ce test, déjà autorisé par la FDA aux États-Unis, contribuera au diagnostic et au traitement d'environ 2,7 millions de personnes diagnostiquées avec un cancer chaque année dans l'UE.
Ce test de diagnostic in vitro peut analyser simultanément plusieurs biomarqueurs, même avec des échantillons de tissus limités, permettant des plans de prise en charge des patients plus rapides et efficaces. Le test sera disponible via le laboratoire central de Labcorp à Genève, en Suisse, soutenant à la fois les partenaires biopharmaceutiques et l'utilisation expérimentale dans des essais cliniques mondiaux.
Labcorp (NYSE: LH) hat für seinen Test PGDx elio tissue complete in der Europäischen Union die IVDR-CE-Kennzeichnung erhalten und ist damit der erste und einzige Test seiner Art, der unter den neuen EU-Vorschriften eine umfassende Profilierung solider Tumoren erlaubt. Der Test, der bereits die FDA-Zulassung in den USA besitzt, wird bei der Diagnose und Behandlung von jährlich etwa 2,7 Millionen Krebspatienten in der EU helfen.
Der in-vitro-Diagnostiktest kann mehrere Biomarker gleichzeitig analysieren, selbst bei begrenztem Gewebeprobenmaterial, was schnellere und effektivere Patientenmanagementpläne ermöglicht. Der Test wird über Labcorps zentrales Labor in Genf, Schweiz, verfügbar sein und sowohl Biopharma-Partner als auch die experimentelle Nutzung in globalen klinischen Studien unterstützen.
- First and only test of its kind CE-marked for comprehensive solid tumor profiling in the EU
- Dual regulatory approval with both FDA clearance and IVDR CE-mark
- Enables analysis of multiple biomarkers with limited tissue samples
- Helps laboratories bring testing in-house while lowering costs
- Expands access to personalized cancer care for 2.7 million EU cancer patients annually
- None.
Insights
Labcorp's CE-mark approval for PGDx elio tissue complete enables broader EU cancer biomarker testing access with significant market advantage.
Labcorp has secured a strategic competitive advantage by obtaining the CE-mark under the EU's stringent new IVDR regulations for its PGDx elio tissue complete test. This regulatory achievement positions Labcorp as the first and only provider of this comprehensive solid tumor profiling technology in the European Union—a market with approximately 2.7 million new cancer diagnoses annually.
The dual regulatory approvals (FDA clearance in the US and now IVDR CE-mark in Europe) significantly enhance the test's commercial viability and clinical credibility. This comprehensive genomic profiling assay addresses a critical clinical need by analyzing multiple biomarkers simultaneously, even with limited tissue samples—a common challenge in oncology diagnostics that often leads to treatment delays.
From a market perspective, this approval creates multiple revenue opportunities:
The ability to perform comprehensive biomarker testing with minimal tissue represents a significant clinical advancement that can expedite treatment decisions for cancer patients. This aligns with the growing trend toward precision oncology, where treatment selection is increasingly guided by molecular profiling rather than traditional cancer classification methods.
First-and-only test of its kind approved under new European Union regulations expands access to personalized cancer care for patients across the EU
This in vitro diagnostic (IVD) assay, which has been cleared by the
"This accomplishment reflects Labcorp's commitment to advancing precision medicine and improving patient care," said Shakti Ramkissoon, M.D., Ph.D., MBA, vice president, medical lead for oncology at Labcorp. "With both FDA clearance and IVDR CE-mark, this test sets a new standard for quality and performance in cancer diagnostics. Importantly, it also provides our biopharma partners with a reliable, regulatory-ready solution to de-risk multiyear clinical trial strategies, ensuring continuity in NGS testing for trials that will extend beyond the IVDR transition timelines."
PGDx elio tissue complete makes it easier for laboratories to bring testing in-house while lowering costs, accelerating implementation, and helping patients get tested sooner.
As Labcorp prepares to make the CE-marked assay available for biopharma partners and for investigational use in global clinical trials through Labcorp's central laboratory in
For more information, visit https://www.labcorp.com/ivdr-elio-tissue-complete.
About Labcorp
Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's nearly 70,000 employees serve clients in approximately 100 countries, provided support for more than
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SOURCE Labcorp
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