Labcorp Receives FDA De Novo Marketing Authorization for PGDx elio™ plasma focus Dx
Labcorp (NYSE: LH) has received FDA De Novo marketing authorization for PGDx elio™ plasma focus Dx, the industry's first and only kitted, pan-solid tumor liquid biopsy test. This innovative test enables tumor mutation profiling from a simple blood draw, offering a convenient solution when tissue samples are or unavailable. The test uses next-generation sequencing to detect various genetic alterations in 33 genes, including single nucleotide variants, insertions, deletions, copy number amplifications, and translocations.
PGDx elio plasma focus Dx complements Labcorp's existing tissue-based test, allowing laboratories to perform both tissue and liquid genomic profiling on the same instrument. This integration streamlines workflows and provides critical data for personalized cancer treatments. The test targets guideline-recommended biomarkers and uses automated bioinformatics for faster results, enhancing oncologists' ability to make timely treatment decisions.
Labcorp (NYSE: LH) ha ricevuto l'autorizzazione al marketing De Novo dalla FDA per il PGDx elio™ plasma focus Dx, il primo e unico test per biopsia liquida pan-tumorale disponibile come kit nel settore. Questo test innovativo consente di effettuare il profilo delle mutazioni tumorali tramite un semplice prelievo di sangue, offrendo una soluzione conveniente quando i campioni di tessuto sono o non sono disponibili. Il test utilizza il sequenziamento di nuova generazione per rilevare varie alterazioni genetiche in 33 geni, comprese le variazioni di singolo nucleotide, inserzioni, delezioni, amplificazioni del numero di copie e traslocazioni.
Il PGDx elio plasma focus Dx integra il test basato su tessuto già esistente di Labcorp, consentendo ai laboratori di eseguire il profilo genomico sia dei tessuti che dei liquidi sullo stesso strumento. Questa integrazione semplifica i flussi di lavoro e fornisce dati critici per trattamenti personalizzati contro il cancro. Il test si concentra su biomarcatori raccomandati dalle linee guida e utilizza bioinformatica automatizzata per risultati più rapidi, migliorando la capacità degli oncologi di prendere decisioni tempestive sui trattamenti.
Labcorp (NYSE: LH) ha recibido la autorización de comercialización De Novo de la FDA para el PGDx elio™ plasma focus Dx, la primera y única prueba de biopsia líquida para tumores sólidos disponible en forma de kit en la industria. Esta prueba innovadora permite el perfilado de mutaciones tumorales a partir de una simple extracción de sangre, ofreciendo una solución conveniente cuando las muestras de tejido son o no están disponibles. La prueba utiliza secuenciación de nueva generación para detectar diversas alteraciones genéticas en 33 genes, incluidos variantes de un solo nucleótido, inserciones, deleciones, amplificaciones del número de copias y translocaciones.
El PGDx elio plasma focus Dx complementa la prueba basada en tejido existente de Labcorp, permitiendo a los laboratorios realizar el perfilado genómico tanto de tejidos como de líquidos en el mismo instrumento. Esta integración optimiza los flujos de trabajo y proporciona datos críticos para tratamientos personalizados del cáncer. La prueba se centra en biomarcadores recomendados por las guías y utiliza bioinformática automatizada para resultados más rápidos, mejorando la capacidad de los oncólogos para tomar decisiones de tratamiento oportunas.
Labcorp (NYSE: LH)은 업계 최초의 키트형 판-고형 종양 액체 생검 테스트인 PGDx elio™ plasma focus Dx에 대한 FDA의 De Novo 마케팅 승인을 받았습니다. 이 혁신적인 테스트는 간단한 혈액 채취를 통해 종양 변이 프로파일링을 가능하게 하여, 조직 샘플이 없거나 이용할 수 없을 때 편리한 솔루션을 제공합니다. 이 테스트는 차세대 시퀀싱을 사용하여 33개 유전자의 다양한 유전적 변화를 감지하며, 단일 뉴클레오타이드 변이, 삽입, 삭제, 복제 수 증가 및 전위와 같은 요소를 포함합니다.
PGDx elio plasma focus Dx는 Labcorp의 기존 조직 기반 테스트를 보완하여, 실험실에서 동일한 기기를 사용하여 조직 및 액체의 유전체 프로파일링을 수행할 수 있게 합니다. 이러한 통합은 작업 흐름을 간소화하고 개인화된 암 치료를 위한 중요한 데이터를 제공합니다. 이 테스트는 가이드라인 추천 바이오마커를 목표로 하며, 빠른 결과를 위해 자동화된 생물정보학을 사용하여 온콜로지스트가 적시에 치료 결정을 내릴 수 있도록 지원합니다.
Labcorp (NYSE: LH) a reçu l'autorisation de mise sur le marché De Novo de la FDA pour le PGDx elio™ plasma focus Dx, le premier et unique test de biopsie liquidienne pan-tumorale disponible en kit sur le marché. Ce test innovant permet le profilage des mutations tumorales à partir d'une simple prise de sang, offrant une solution pratique lorsque les échantillons de tissu sont indisponibles ou manquants. Le test utilise le séquençage de nouvelle génération pour détecter diverses altérations génétiques dans 33 gènes, y compris des variations de nucléotides uniques, des insertions, des suppressions, des amplifications du nombre de copies et des translocations.
Le PGDx elio plasma focus Dx complète le test basé sur tissu existant de Labcorp, permettant aux laboratoires de réaliser à la fois le profilage génomique tissulaire et liquidien sur le même instrument. Cette intégration rationalise les flux de travail et fournit des données critiques pour des traitements personnalisés contre le cancer. Le test cible des biomarqueurs recommandés par les directives et utilise de la bioinformatique automatisée pour des résultats plus rapides, améliorant ainsi la capacité des oncologues à prendre des décisions de traitement en temps opportun.
Labcorp (NYSE: LH) hat die FDA-Zulassung für das PGDx elio™ plasma focus Dx, den ersten und einzigen pan-solid Tumor-Liquid-Biopsietest der Branche in Form eines Kits, erhalten. Dieser innovative Test ermöglicht das Mutationsprofiling von Tumoren aus einer einfachen Blutentnahme und bietet eine praktische Lösung, wenn Gewebeproben nicht oder nicht verfügbar sind. Der Test verwendet Nächste-Generations-Sequenzierung, um verschiedene genetische Veränderungen in 33 Genen zu erkennen, einschließlich einzelner Nukleotidvarianten, Insertionen, Deletionen, Kopienzahlveränderungen und Translokationen.
PGDx elio plasma focus Dx ergänzt den bestehenden Gewebetest von Labcorp, was es Laboren ermöglicht, sowohl Gewebe- als auch Flüssigkeitsgenomprofilierung mit demselben Instrument durchzuführen. Diese Integration optimiert die Arbeitsabläufe und bietet wichtige Daten für personalisierte Krebsbehandlungen. Der Test zielt auf nach Richtlinien empfohlene Biomarker ab und nutzt automatisierte Bioinformatik für schnellere Ergebnisse, wodurch die Fähigkeit von Onkologen verbessert wird, rechtzeitige Behandlungsentscheidungen zu treffen.
- First FDA-authorized kitted, pan-solid tumor liquid biopsy test
- Enables tumor profiling when tissue samples are or unavailable
- Complements existing tissue-based test, allowing for seamless integration into laboratory workflows
- Targets guideline-recommended biomarkers for accurate clinical assessments
- Uses automated bioinformatics for faster results
- None.
The FDA's De Novo marketing authorization for Labcorp's PGDx elio™ plasma focus Dx marks a significant milestone in liquid biopsy technology. As the first and only kitted, pan-solid tumor liquid biopsy test, this innovation could revolutionize cancer diagnostics and treatment planning.
Key advantages of this test include:
- Non-invasive sampling through a simple blood draw, reducing patient discomfort and complications associated with tissue biopsies
- Ability to perform genomic profiling when tissue samples are or unavailable, potentially expanding the pool of patients who can benefit from precision oncology
- Targeting of 33 genes for SNVs and indels, 5 genes for CNAs and 3 genes for translocations, covering a comprehensive range of clinically relevant biomarkers
- Automated bioinformatics for faster result delivery, potentially speeding up treatment decisions
The test's ability to work alongside the PGDx elio™ tissue complete assay on the same instrument is a significant operational advantage for laboratories. This integration could streamline workflows and potentially reduce costs, making advanced genomic profiling more accessible.
However, it's important to note that liquid biopsies have limitations, such as potentially lower sensitivity compared to tissue biopsies, especially for early-stage cancers. The true clinical utility and cost-effectiveness of this test will need to be demonstrated through real-world use and further studies.
The introduction of PGDx elio™ plasma focus Dx represents a significant advancement in precision oncology. As an oncologist, I see several potential benefits for patient care:
- Expanded access to genomic profiling: For patients with tumors that are difficult to biopsy or when tissue samples are depleted, this liquid biopsy offers a valuable alternative for obtaining important genetic information.
- Monitoring treatment response and disease progression: The non-invasive nature of the test allows for more frequent testing, potentially enabling closer monitoring of treatment efficacy and early detection of disease progression or resistance.
- Comprehensive biomarker coverage: The test's ability to detect SNVs, indels, CNAs and translocations across multiple genes aligns with guideline recommendations, supporting evidence-based treatment decisions.
- Timely decision-making: With automated bioinformatics and accelerated results, oncologists can make more timely treatment decisions, which is important in rapidly evolving cancers.
However, it's important to consider some limitations:
- Sensitivity concerns: Liquid biopsies may have lower sensitivity compared to tissue biopsies, particularly for early-stage cancers or those that shed less DNA into the bloodstream.
- Interpretation challenges: The complexity of genomic data requires expertise in interpretation and the clinical significance of some detected alterations may not always be clear.
- Need for clinical validation: While promising, the real-world performance and clinical utility of this test across various cancer types and stages will need to be thoroughly evaluated.
Overall, the PGDx elio™ plasma focus Dx has the potential to enhance our ability to deliver personalized cancer care, but its integration into clinical practice should be guided by ongoing research and careful consideration of its strengths and limitations.
Labcorp's FDA De Novo marketing authorization for PGDx elio™ plasma focus Dx positions the company at the forefront of the rapidly growing liquid biopsy market. This development has several financial implications:
- Market expansion: The global liquid biopsy market is projected to grow significantly, with some estimates suggesting a CAGR of over
20% in the coming years. Labcorp's first-mover advantage with a kitted, pan-solid tumor test could capture a substantial market share. - Revenue diversification: This product adds to Labcorp's precision oncology portfolio, potentially driving growth in its diagnostics segment and reducing reliance on traditional laboratory services.
- Operational synergies: The compatibility with PGDx elio™ tissue complete on the same instrument could lead to operational efficiencies for laboratories, potentially increasing adoption and recurring revenue from consumables.
- Competitive positioning: As the "first and only" in its category, Labcorp may enjoy a period of competition, allowing for premium pricing and higher margins.
However, investors should consider:
- Regulatory landscape: The evolving regulatory environment for liquid biopsies could impact future market access and reimbursement.
- Competition: Major players in the diagnostics industry are likely to introduce competing products, potentially eroding Labcorp's market share over time.
- Clinical adoption: The rate of adoption by oncologists and integration into clinical guidelines will significantly influence the financial success of this product.
While specific financial projections are not provided, this authorization could be a significant growth driver for Labcorp's oncology diagnostics business. Investors should monitor the product's market penetration, reimbursement status and clinical validation studies to assess its long-term financial impact on the company.
PGDx elio™ plasma focus Dx is the industry's first and only kitted, pan-solid tumor liquid biopsy test that enables tumor mutation profiling – all from a simple blood draw
PGDx elio plasma focus Dx builds on the success of PGDx elio™ tissue complete and enables laboratories to perform genomic profiling when tissue is limited or unavailable.
"The launch of PGDx elio plasma focus Dx represents a landmark expansion of Labcorp's suite of precision oncology solutions," said Shakti Ramkissoon, M.D., Ph.D., MBA, vice president, medical lead for oncology at Labcorp. "This latest liquid biopsy test offers laboratories and oncologists a convenient, cost-effective and highly targeted tumor-profiling solution that spans a wide range of solid-tumor types – particularly when tumor tissue is limited or unavailable. When paired with PGDx elio tissue complete, Labcorp now offers laboratories access to tissue and liquid genomic-profiling assays that operate on the same instrument, enabling seamless integration of these precision oncology products into routine laboratory workflows. The ability to test tissue or liquid will provide critical data and insights needed to inform more personalized treatments and care plans for patients."
PGDx elio plasma focus Dx is a qualitative next-generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for the detection of single nucleotide variants (SNVs), insertions and deletions (indels) in 33 genes, copy number amplifications (CNAs) in five genes, and translocations in three genes. The assay targets guideline-recommended biomarkers to enable more accurate clinical assessments and is coupled with automated bioinformatics to deliver accelerated results. This solution enhances oncologists' ability to make timely treatment decisions in conjunction with other laboratory and clinical findings while also promoting sample and data ownership.
PGDx elio plasma focus Dx is part of Labcorp's comprehensive precision oncology portfolio of testing solutions. For more information, visit https://www.personalgenome.com
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 more than 67,000 employees serve clients in approximately 100 countries, provided support for
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