Labcorp Announces Clinical Availability of Liquid Biopsy Test to Guide Personalized Treatment Plans for Patients with Advanced Solid Tumors
Labcorp (NYSE: LH) has announced the clinical availability of Labcorp® Plasma Complete™, a liquid biopsy test for comprehensive genomic profiling in patients with advanced solid tumors. The test analyzes circulating tumor DNA (ctDNA) from a simple blood draw, detecting genomic alterations across 521 genes, including various mutations, amplifications in 12 genes, and translocations associated with 12 genes.
The test features high sensitivity with variant detection as low as 0.1% and specificity exceeding 99.99%. It provides insights for FDA-approved therapies, guideline-driven treatments, and clinical trial eligibility. The solution has been validated in Labcorp's CAP-accredited and CLIA-certified laboratory, with validation studies published in the Journal of Molecular Diagnostics confirming its clinical accuracy.
Labcorp (NYSE: LH) ha annunciato la disponibilità clinica di Labcorp® Plasma Complete™, un test di biopsia liquida per la profilazione genomica completa nei pazienti con tumori solidi avanzati. Il test analizza il DNA tumorale circolante (ctDNA) da un semplice prelievo di sangue, rilevando alterazioni genomiche in 521 geni, comprese varie mutazioni, amplificazioni in 12 geni e traslocazioni associate a 12 geni.
Il test presenta un'alta sensibilità con rilevamento di varianti fino allo 0,1% e una specificità superiore al 99,99%. Fornisce informazioni per terapie approvate dalla FDA, trattamenti basati su linee guida e idoneità per studi clinici. La soluzione è stata convalidata nel laboratorio accreditato CAP e certificato CLIA di Labcorp, con studi di convalida pubblicati nel Journal of Molecular Diagnostics che confermano la sua accuratezza clinica.
Labcorp (NYSE: LH) ha anunciado la disponibilidad clínica de Labcorp® Plasma Complete™, una prueba de biopsia líquida para el perfil genómico completo en pacientes con tumores sólidos avanzados. La prueba analiza el ADN tumoral circulante (ctDNA) a partir de una simple extracción de sangre, detectando alteraciones genómicas en 521 genes, incluidas varias mutaciones, amplificaciones en 12 genes y translocaciones asociadas a 12 genes.
La prueba cuenta con una alta sensibilidad, con detección de variantes tan bajas como el 0,1% y una especificidad que supera el 99,99%. Proporciona información para terapias aprobadas por la FDA, tratamientos basados en guías y elegibilidad para ensayos clínicos. La solución ha sido validada en el laboratorio acreditado por CAP y certificado por CLIA de Labcorp, con estudios de validación publicados en el Journal of Molecular Diagnostics que confirman su precisión clínica.
Labcorp (NYSE: LH)는 진행성 고형 종양 환자를 위한 포괄적인 유전체 프로파일링을 위한 액체 생검 테스트인 Labcorp® Plasma Complete™의 임상 가용성을 발표했습니다. 이 테스트는 간단한 혈액 채취를 통해 순환 종양 DNA (ctDNA)를 분석하여 521개 유전자
이 테스트는 0.1%까지 낮은 변이 감지로 높은 민감도를 제공하며, 특이도는 99.99%를 초과합니다. FDA 승인 치료, 가이드라인 기반 치료 및 임상 시험 적격성에 대한 통찰력을 제공합니다. 이 솔루션은 Labcorp의 CAP 인증 및 CLIA 인증 실험실에서 검증되었으며, Journal of Molecular Diagnostics에 발표된 검증 연구가 임상 정확성을 확인했습니다.
Labcorp (NYSE: LH) a annoncé la disponibilité clinique de Labcorp® Plasma Complete™, un test de biopsie liquide pour le profilage génomique complet chez les patients atteints de tumeurs solides avancées. Le test analyse l'ADN tumoral circulant (ctDNA) à partir d'une simple prise de sang, détectant des altérations génomiques dans 521 gènes, y compris diverses mutations, des amplifications dans 12 gènes et des translocations associées à 12 gènes.
Le test présente une grande sensibilité avec une détection de variantes aussi basse que 0,1 % et une spécificité dépassant 99,99 %. Il fournit des informations pour des thérapies approuvées par la FDA, des traitements guidés par des recommandations et l'éligibilité aux essais cliniques. La solution a été validée dans le laboratoire accrédité par le CAP et certifié par le CLIA de Labcorp, avec des études de validation publiées dans le Journal of Molecular Diagnostics confirmant son exactitude clinique.
Labcorp (NYSE: LH) hat die klinische Verfügbarkeit von Labcorp® Plasma Complete™ bekannt gegeben, einem flüssigen Biopsietest für umfassende genomische Profilierung bei Patienten mit fortgeschrittenen soliden Tumoren. Der Test analysiert zirkulierende Tumor-DNA (ctDNA) aus einer einfachen Blutentnahme und erkennt genomische Veränderungen in 521 Genen, einschließlich verschiedener Mutationen, Amplifikationen in 12 Genen und Translokationen, die mit 12 Genen assoziiert sind.
Der Test bietet eine hohe Sensitivität mit einer Variantenerkennung von bis zu 0,1% und einer Spezifität von über 99,99%. Er liefert Einblicke in von der FDA zugelassene Therapien, leitlinienbasierte Behandlungen und die Eignung für klinische Studien. Die Lösung wurde im von CAP akkreditierten und CLIA-zertifizierten Labor von Labcorp validiert, und Validierungsstudien, die im Journal of Molecular Diagnostics veröffentlicht wurden, bestätigen ihre klinische Genauigkeit.
- Launch of innovative liquid biopsy test expanding diagnostic portfolio
- High test accuracy with >99.99% specificity and 0.1% detection sensitivity
- Comprehensive coverage of 521 genes for targeted treatment decisions
- Test validated and published in peer-reviewed journal
- None.
Insights
The clinical launch of Plasma Complete marks a strategic expansion of Labcorp's oncology testing portfolio, addressing a rapidly growing market segment estimated to reach
Three key competitive advantages stand out:
- The comprehensive 521-gene panel surpasses many competing tests that typically analyze 50-70 genes, providing broader coverage of actionable mutations
- The integration with Labcorp's existing oncology portfolio creates a compelling value proposition for healthcare providers seeking consolidated testing services
- The dual-use capability for both clinical care and biopharmaceutical research establishes additional revenue streams and data collection opportunities
The liquid biopsy approach addresses critical limitations of traditional tissue biopsies, including invasiveness, tumor heterogeneity, and inability to monitor treatment response in real-time. This is particularly valuable for the approximately
From a business perspective, the test strengthens Labcorp's position in the precision oncology market, potentially driving both volume growth in routine clinical testing and expanding opportunities in pharmaceutical research partnerships. The robust validation data and regulatory compliance (CAP/CLIA certification) should facilitate insurance coverage and market adoption, though the initial rollout phase will likely focus on early adopters and academic medical centers.
Labcorp® Plasma CompleteTM offers oncologists a highly sensitive and specific genomic profiling solution from a simple blood draw
"Labcorp Plasma Complete delivers powerful and comprehensive genomic insights and helps guide targeted treatment decisions even when tissue-based testing is not feasible," said Shakti Ramkissoon, M.D., Ph.D., MBA, vice president and medical lead for oncology at Labcorp. "Now available for clinical use, Labcorp's solution further expands Labcorp's extensive oncology portfolio and reflects our commitment to supporting oncologists in delivering more personalized patient care."
Labcorp Plasma Complete detects genomic alterations in ctDNA across 521 genes. This includes single nucleotide variants (SNVs) and insertions/deletions (InDels), amplifications in 12 genes, translocations associated with 12 genes, and microsatellite instability (MSI) high status. The assay covers established and emerging biomarkers associated with FDA-approved therapies, guideline-driven treatments and clinical trial eligibility, providing oncologists with key insights to support personalized patient care.
Labcorp Plasma Complete also provides clear and comprehensive clinical reports supported by robust bioinformatics, simplifying the interpretation of complex genomic data and reducing the burden on oncologists. Integrating these capabilities with Labcorp's broad cancer diagnostic portfolio helps reduce complexity for providers and guides treatment decisions across all stages of cancer care.
Labcorp Plasma Complete continues to be available for use in biopharmaceutical research in addition to its new application for clinical patient care. Labcorp Plasma Complete is a laboratory-developed test (LDT) and was validated in Labcorp's College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.i
Rigorous validation studies published in the Journal of Molecular Diagnostics confirmed the test's clinical accuracy and reliability. The test offers a reportable range with a variant allele frequency as low as
For more information about Labcorp Plasma Complete, visit https://oncology.labcorp.com/plasma-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
i This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
View original content to download multimedia:https://www.prnewswire.com/news-releases/labcorp-announces-clinical-availability-of-liquid-biopsy-test-to-guide-personalized-treatment-plans-for-patients-with-advanced-solid-tumors-302383329.html
SOURCE Labcorp
FAQ
What is Labcorp's new Plasma Complete test and how does it work?
What is the accuracy rate of Labcorp's Plasma Complete (LH) test?
How many genes can Labcorp's Plasma Complete test analyze?
What certifications and validations does Labcorp's Plasma Complete test have?
