Labcorp Launches Molecular Residual Disease and Liquid Biopsy Solutions
Labcorp (NYSE: LH) has expanded its precision oncology portfolio with two groundbreaking solutions. The first is Labcorp Plasma Detect, a blood-based test using whole-genome sequencing to assess recurrence risk in stage III colon cancer patients, which has a nearly 30% recurrence rate within five years. The test can detect circulating tumor DNA (ctDNA) with a detection limit of 0.005% and delivers results in approximately 14 days.
The second solution is the PGDx elio plasma focus Dx, the first FDA-authorized kitted pan-solid tumor liquid biopsy test. This innovative test supports treatment selection through a simple blood draw, with results available in 4-5 days. The test allows clinical laboratories to maintain control over patient specimens and requires only on-site verification for implementation.
Both solutions will be featured at the AACR 2025 Annual Meeting in Chicago, demonstrating Labcorp's commitment to advancing cancer diagnostics and improving patient outcomes.
Labcorp (NYSE: LH) ha ampliato il suo portafoglio di oncologia di precisione con due soluzioni rivoluzionarie. La prima è Labcorp Plasma Detect, un test su sangue che utilizza il sequenziamento dell'intero genoma per valutare il rischio di recidiva nei pazienti con cancro del colon in stadio III, che presenta un tasso di recidiva di quasi il 30% entro cinque anni. Il test è in grado di rilevare il DNA tumorale circolante (ctDNA) con un limite di rilevamento dello 0,005% e fornisce i risultati in circa 14 giorni.
La seconda soluzione è il PGDx elio plasma focus Dx, il primo test di biopsia liquida kit FDA-autorizzato per tumori solidi pan-tumorali. Questo test innovativo supporta la selezione del trattamento tramite un semplice prelievo di sangue, con risultati disponibili in 4-5 giorni. Il test permette ai laboratori clinici di mantenere il controllo sui campioni dei pazienti e richiede solo una verifica in loco per l’implementazione.
Entrambe le soluzioni saranno presentate al AACR 2025 Annual Meeting a Chicago, dimostrando l’impegno di Labcorp nel promuovere l’innovazione nella diagnostica oncologica e nel migliorare gli esiti per i pazienti.
Labcorp (NYSE: LH) ha ampliado su cartera de oncología de precisión con dos soluciones innovadoras. La primera es Labcorp Plasma Detect, una prueba basada en sangre que utiliza la secuenciación del genoma completo para evaluar el riesgo de recurrencia en pacientes con cáncer de colon en estadio III, que presenta una tasa de recurrencia cercana al 30% en cinco años. La prueba puede detectar ADN tumoral circulante (ctDNA) con un límite de detección del 0,005% y entrega resultados en aproximadamente 14 días.
La segunda solución es el PGDx elio plasma focus Dx, la primera prueba kit de biopsia líquida autorizada por la FDA para tumores sólidos pan-tumorales. Esta prueba innovadora apoya la selección del tratamiento mediante una simple extracción de sangre, con resultados disponibles en 4-5 días. La prueba permite a los laboratorios clínicos mantener el control sobre las muestras de los pacientes y solo requiere verificación in situ para su implementación.
Ambas soluciones se presentarán en el AACR 2025 Annual Meeting en Chicago, demostrando el compromiso de Labcorp con el avance del diagnóstico del cáncer y la mejora de los resultados para los pacientes.
Labcorp (NYSE: LH)는 정밀 종양학 포트폴리오를 두 가지 혁신적인 솔루션으로 확장했습니다. 첫 번째는 Labcorp Plasma Detect로, 전장 유전체 시퀀싱을 이용한 혈액 기반 검사로 5년 내 약 30% 재발률을 보이는 3기 대장암 환자의 재발 위험을 평가합니다. 이 검사는 0.005%의 검출 한계로 순환 종양 DNA(ctDNA)를 감지하며, 결과는 약 14일 내에 제공됩니다.
두 번째 솔루션은 PGDx elio plasma focus Dx로, FDA 승인된 최초의 키트형 전고형종양 액체생검 검사입니다. 이 혁신적인 검사는 간단한 혈액 채취로 치료 선택을 지원하며, 결과는 4-5일 내에 나옵니다. 임상 실험실이 환자 샘플을 직접 관리할 수 있고, 현장 검증만으로 구현이 가능합니다.
두 솔루션 모두 AACR 2025 Annual Meeting 시카고에서 선보일 예정이며, Labcorp가 암 진단 발전과 환자 치료 성과 향상에 기여하고 있음을 보여줍니다.
Labcorp (NYSE : LH) a élargi son portefeuille en oncologie de précision avec deux solutions révolutionnaires. La première est Labcorp Plasma Detect, un test sanguin utilisant le séquençage du génome complet pour évaluer le risque de récidive chez les patients atteints d’un cancer du côlon de stade III, qui présente un taux de récidive d’environ 30 % sur cinq ans. Ce test peut détecter l’ADN tumoral circulant (ctDNA) avec une limite de détection de 0,005 % et fournit les résultats en environ 14 jours.
La seconde solution est le PGDx elio plasma focus Dx, le premier test de biopsie liquide pan-tumoral pour tumeurs solides autorisé par la FDA sous forme de kit. Ce test innovant facilite le choix du traitement grâce à une simple prise de sang, avec des résultats disponibles en 4 à 5 jours. Le test permet aux laboratoires cliniques de garder le contrôle des échantillons des patients et ne nécessite qu’une vérification sur site pour sa mise en œuvre.
Les deux solutions seront présentées lors du AACR 2025 Annual Meeting à Chicago, témoignant de l’engagement de Labcorp à faire progresser le diagnostic du cancer et à améliorer les résultats pour les patients.
Labcorp (NYSE: LH) hat sein Portfolio im Bereich der Präzisionsonkologie um zwei bahnbrechende Lösungen erweitert. Die erste ist Labcorp Plasma Detect, ein blutbasierter Test, der mittels Ganzgenomsequenzierung das Rückfallrisiko bei Patienten mit Kolonkarzinom im Stadium III bewertet, bei dem die Rückfallrate innerhalb von fünf Jahren fast 30 % beträgt. Der Test kann zirkulierende Tumor-DNA (ctDNA) mit einer Nachweisgrenze von 0,005 % detektieren und liefert Ergebnisse in etwa 14 Tagen.
Die zweite Lösung ist der PGDx elio plasma focus Dx, der erste von der FDA zugelassene Kit-basierte Liquid-Biopsy-Test für solide Tumoren. Dieser innovative Test unterstützt die Therapieauswahl durch eine einfache Blutentnahme, die Ergebnisse sind in 4-5 Tagen verfügbar. Der Test ermöglicht es klinischen Laboren, die Kontrolle über Patientenproben zu behalten und erfordert nur eine Vor-Ort-Verifizierung für die Implementierung.
Beide Lösungen werden auf dem AACR 2025 Annual Meeting in Chicago vorgestellt und zeigen Labcorps Engagement für die Weiterentwicklung der Krebsdiagnostik und die Verbesserung der Patientenergebnisse.
- First FDA-authorized kitted pan-solid tumor liquid biopsy test
- High precision with 0.005% detection limit for ctDNA
- Quick turnaround times for test results
- Comprehensive cancer monitoring capabilities
- Expanding clinical study presence
- Initial availability through Early Experience Program
- Complex implementation process for healthcare facilities
- Requires specific laboratory infrastructure
- initial focus on stage III colon cancer
Labcorp® Plasma Detect™ now available for clinical use to assess risk of recurrence in stage III colon cancer patients
FDA-authorized liquid biopsy assay PGDx elio® plasma focus™ Dx now available to support treatment selection
"Labcorp is dedicated to providing oncologists with a comprehensive portfolio of innovative solutions that enable precise, timely and personalized treatment decisions," said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp. "With the expansion of our portfolio to include Labcorp Plasma Detect for clinical use and the availability of PGDx elio plasma focus Dx to support patient treatment selection, we're advancing care across the oncology spectrum, solidifying our commitment to transforming cancer diagnostics and improving patient outcomes."
Labcorp Plasma Detect: Advanced Risk Assessment for Colon Cancer Patients
Stage III colon cancer has a nearly
Key Features of Labcorp Plasma Detect:
- The test is Labcorp's first tumor-informed MRD solution for clinical use to support recurrence risk stratification. Labcorp Plasma Detect launched in 2024 for biopharma use to support exploratory and investigational studies.
- The test combines a WGS approach, without the need for a bespoke panel, with proprietary bioinformatics to deliver ctDNA detection down to a limit of detection (LOD95) of
0.005% . - Results are available approximately 14 days after Labcorp receives the initial sample, and seven days for subsequent monitoring time points for each patient.
- Labcorp Plasma Detect is currently being evaluated in more than 10 clinical studies in the
U.S. and internationally to assess MRD across various cancer types.
Labcorp Plasma Detect will be offered initially through an Early Experience Program, with the intent to expand availability more broadly.
PGDx elio plasma focus Dx Now Available for Use to Aid in Treatment Selection
PGDx elio plasma focus Dx is the first and only kitted pan-solid tumor liquid biopsy test to receive De Novo authorization from the FDA. This assay provides oncologists with a validated tool to assess various solid tumors for targeted treatment selection – all from a simple blood draw.
Key Features of PGDx elio plasma focus Dx:
- The kitted model allows clinical laboratories and hospitals to retain control over patient specimens and data for research, care management and other clinical purposes.
- As an FDA-authorized assay, PGDx elio plasma focus Dx requires only on-site verification – as opposed to a full validation – enabling more rapid implementation.
- Once implemented, this rapid, scalable liquid biopsy genomic test provides actionable findings within a 4-to-5-day turnaround time, from isolated nucleic acid to variant report.
- As part of the PGDx elio platform, the kitted model is compatible with FDA-cleared PGDx elio™ tissue complete, enabling seamless, in-house tissue-to-liquid reflexing and efficient comprehensive genomic profiling workflows.
Labcorp at the American Association for Cancer Research (AACR) 2025 Annual Meeting
Labcorp will present key studies at the AACR 2025 Annual Meeting, including the clinical use of Labcorp Plasma Detect and performance of PGDx elio plasma focus Dx.
To learn more, or to connect with Labcorp at AACR in
For more information about Labcorp's Oncology solutions, contact us at https://oncology.labcorp.com/contact-us
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 The term MRD is often used interchangeably between molecular residual disease and minimal residual disease. Labcorp Plasma Detect detects molecular residual disease, which is defined as the subclinical presence of a cancer-associated biomarker indicating a high risk of recurrence, which cannot be detected by standard imaging techniques. MRD terminology is in accordance with the BLOODPAC Consortium.
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SOURCE Labcorp
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