BioMark Diagnostics Announces Landmark Publication Validating High Specificity and Accuracy of Its Early-Stage Lung Cancer Test
BioMark Diagnostics (BMKDF) has published a landmark study validating its liquid biopsy test for early-stage lung cancer detection in the International Journal of Molecular Sciences. The study analyzed 680 plasma samples in a discovery cohort and 216 samples for validation, demonstrating the test's ability to distinguish early-stage non-small cell lung cancer (NSCLC) from non-cancerous lung conditions.
The research achieved remarkable results with Area Under the ROC Curve (AUROC) values exceeding 93% for detecting stage I-II NSCLC. The study's control group notably included patients with various non-cancerous lung diseases, strengthening the validation of the test's specificity. This blood-based test offers advantages over current screening methods like low dose computed tomography (LDCT), which can produce false positives leading to unnecessary procedures.
BioMark Diagnostics (BMKDF) ha pubblicato uno studio fondamentale che convalida il suo test di biopsia liquida per la rilevazione precoce del cancro ai polmoni sul International Journal of Molecular Sciences. Lo studio ha analizzato 680 campioni di plasma in una coorte di scoperta e 216 campioni per la validazione, dimostrando la capacità del test di distinguere il cancro polmonare non a piccole cellule (NSCLC) in fase iniziale da condizioni polmonari non cancerose.
La ricerca ha raggiunto risultati notevoli con valori di Area sotto la curva ROC (AUROC) superiori al 93% per la rilevazione di NSCLC in stadio I-II. Il gruppo di controllo dello studio includeva pazienti con varie malattie polmonari non cancerose, rafforzando la validazione della specificità del test. Questo test basato sul sangue offre vantaggi rispetto ai metodi di screening attuali come la tomografia computerizzata a bassa dose (LDCT), che può generare falsi positivi portando a procedure non necessarie.
BioMark Diagnostics (BMKDF) ha publicado un estudio pionero que valida su prueba de biopsia líquida para la detección temprana del cáncer de pulmón en el International Journal of Molecular Sciences. El estudio analizó 680 muestras de plasma en una cohorte de descubrimiento y 216 muestras para validación, demostrando la capacidad de la prueba para distinguir el cáncer de pulmón no microcítico (NSCLC) en etapas tempranas de condiciones pulmonares no cancerosas.
La investigación alcanzó resultados notables con valores de Área bajo la curva ROC (AUROC) superiores al 93% para detectar NSCLC en etapa I-II. El grupo de control del estudio incluyó pacientes con diversas enfermedades pulmonares no cancerosas, fortaleciendo la validación de la especificidad de la prueba. Esta prueba basada en sangre ofrece ventajas sobre los métodos actuales de detección como la tomografía computarizada de baja dosis (LDCT), que puede producir falsos positivos que conducen a procedimientos innecesarios.
BioMark Diagnostics (BMKDF)는 International Journal of Molecular Sciences에 조기 폐암 검출을 위한 액체 생검 검사에 대한 획기적인 연구를 발표했습니다. 이 연구는 탐색 코호트에서 680개의 혈장 샘플과 검증을 위해 216개의 샘플을 분석하여 이 검사가 초기 비소세포 폐암(NSCLC)과 비암성 폐질환을 구분하는 능력을 입증했습니다.
연구 결과는 1~2기 NSCLC 검출에서 ROC 곡선 아래 면적(AUROC) 값이 93% 이상으로 뛰어난 성과를 보였습니다. 대조군에는 다양한 비암성 폐질환 환자들이 포함되어 검사 특이성 검증을 강화했습니다. 이 혈액 기반 검사는 낮은 선량의 컴퓨터단층촬영(LDCT)과 같은 기존 선별 검사법에 비해 거짓 양성으로 인한 불필요한 절차를 줄일 수 있는 장점이 있습니다.
BioMark Diagnostics (BMKDF) a publié une étude majeure validant son test de biopsie liquide pour la détection précoce du cancer du poumon dans l'International Journal of Molecular Sciences. L'étude a analysé 680 échantillons de plasma dans une cohorte de découverte et 216 échantillons pour validation, démontrant la capacité du test à distinguer un cancer du poumon non à petites cellules (NSCLC) à un stade précoce des affections pulmonaires non cancéreuses.
La recherche a obtenu des résultats remarquables avec des valeurs de surface sous la courbe ROC (AUROC) dépassant 93% pour la détection du NSCLC aux stades I-II. Le groupe témoin de l'étude comprenait notamment des patients atteints de diverses maladies pulmonaires non cancéreuses, renforçant la validation de la spécificité du test. Ce test sanguin présente des avantages par rapport aux méthodes de dépistage actuelles telles que la tomodensitométrie à faible dose (LDCT), qui peut générer des faux positifs entraînant des procédures inutiles.
BioMark Diagnostics (BMKDF) hat eine bahnbrechende Studie veröffentlicht, die ihren Liquid-Biopsy-Test zur Früherkennung von Lungenkrebs in der Frühphase im International Journal of Molecular Sciences validiert. Die Studie analysierte 680 Plasmaproben in einer Entdeckungs-Kohorte und 216 Proben zur Validierung und zeigte, dass der Test in der Lage ist, frühstadiales nicht-kleinzelliges Lungenkarzinom (NSCLC) von nicht-krebsartigen Lungenzuständen zu unterscheiden.
Die Forschung erzielte bemerkenswerte Ergebnisse mit Werten der Fläche unter der ROC-Kurve (AUROC) von über 93% für die Erkennung von NSCLC im Stadium I-II. Die Kontrollgruppe der Studie umfasste Patienten mit verschiedenen nicht-krebsartigen Lungenerkrankungen, was die Validierung der Spezifität des Tests stärkte. Dieser blutbasierte Test bietet Vorteile gegenüber aktuellen Screening-Methoden wie der Niedrigdosis-Computertomographie (LDCT), die falsch-positive Ergebnisse und unnötige Eingriffe verursachen kann.
- Achieved high accuracy with AUROC values over 93% for early-stage lung cancer detection
- Successfully validated test's ability to differentiate cancer from non-cancerous conditions
- Large study size with 896 total plasma samples analyzed
- Test offers advantages over current LDCT screening methods
- Publication in respected peer-reviewed journal provides external validation
- Test still requires broader clinical adoption
- Commercialization timeline and regulatory approvals not specified
Study Published in a special issue of International Journal of Molecular Sciences Confirms Test's Ability to Distinguish Early Lung Cancer from Other Non-Cancerous Lung Diseases
Vancouver, British Columbia--(Newsfile Corp. - May 12, 2025) - BioMark Diagnostics Inc. (CSE: BUX) (FSE: 20B) (OTCQB: BMKDF) ("BioMark"), a leading developer of liquid biopsy tests for early cancer detection, today announced the publication of a pivotal study as part of the special issue Molecular Pathogenesis and Diagnostics of Lung Diseases of the International Journal of Molecular Sciences. The research, titled "Clinical Validation of Plasma Metabolite Markers for Early Lung Cancer Detection", provides significant external validation for BioMark's metabolomics and machine learning powered technology, particularly highlighting its high specificity and accuracy in detecting early-stage non-small cell lung cancer (NSCLC) and differentiating it from other non-cancerous lung conditions.
The study utilized a large, clinically diverse patient cohort, analyzing 680 archived plasma samples in a discovery cohort and an independent set of 216 plasma samples for validation. A key strength of the research was the composition of the control group, which included not only healthy individuals but also patients with various non-cancerous lung diseases. This design allowed for a rigorous assessment of the test's ability to accurately identify lung cancer, minimizing the potential for false positives due to other lung conditions.
Dr. Jean-François Haince, Chief Scientific Officer of BioMark, commented, "We are exceptionally pleased with these results, which builds upon our previous research using a much larger and more clinically complex patient cohort. The inclusion of patients with non-malignant lung conditions in our control group was crucial for truly testing the specificity of our metabolite panel. The models achieved Area Under the ROC Curve (AUROC) values of over
"This publication in a respected peer-reviewed journal is a tremendous milestone for BioMark and a powerful external validation of our team's dedicated work," said Rashid Ahmed Bux, President and CEO of BioMark Diagnostics. "The study's demonstration of high accuracy, particularly its ability to differentiate early-stage cancer from other lung diseases, is critical. It gives us, and the clinical community, greater confidence in our test's potential to become an essential tool in the fight against lung cancer, where early detection is paramount for improving patient survival rates."
The ability to detect lung cancer at its earliest stages significantly improves patient outcomes and survival rates. Current screening methods, such as low dose computed tomography (LDCT), have limitations, including lower sensitivity and specificity compared to regular CT scans, and can result in false positives leading to unnecessary invasive procedures. BioMark's minimally invasive blood test offers a promising approach to complement current screening methods, potentially leading to earlier interventions and better patient prognoses.
The full publication, "Clinical Validation of Plasma Metabolite Markers for Early Lung Cancer Detection", can be downloaded on the International Journal of Molecular Sciences website at https://www.mdpi.com/1422-0067/26/10/4519.
About BioMark Diagnostics Inc.
BioMark Diagnostics Inc. is a leading developer of liquid biopsy tests for the early detection of cancer that leverages the power of metabolomics and machine learning algorithms. The company's proprietary technology utilizes a simple blood draw to detect the presence of cancer-associated biomarkers, enabling earlier diagnosis and improved patient outcomes. The technology can also be used for measuring response to treatment and potentially for serial monitoring of cancer survivors. BioMark is committed to developing innovative and accessible diagnostic solutions to address unmet medical needs in oncology.
Further information about BioMark is available under its profile on the SEDAR+ website www.sedarplus.ca and the CSE website https://thecse.com/.
For further information on BioMark, please Contact:
Rashid Ahmed Bux
President & CEO
BioMark Diagnostics Inc.
Tel. 604-370-0779
Email: info@biomarkdiagnostics.com
Forward-Looking Information:
This press release may include forward-looking information within the meaning of Canadian securities legislation, concerning the business of BioMark. Forward-Looking information is based on certain key expectations and assumptions made by the management of BioMark. Although BioMark believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because BioMark can give no assurance that they will prove to be correct. Forward-Looking statements contained in this press release are made as of the date of this press release. BioMark disclaims any intent or obligation to update publicly any forward-looking information, whether as a result of new information, future events, or results or otherwise, other than as required by applicable securities laws.
The CSE has not reviewed, approved, or disapproved of the content of this press release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/251613
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