Navigate BioPharma Services, Inc. in Collaboration with Partners Validate Analytical Assay for Acute Myeloid Leukemia Measurable Residual Disease (AML-MRD) Assessment

CARLSBAD, Calif., March 15, 2024 /PRNewswire/ -- Navigate BioPharma Services, Inc., a specialty laboratory offering high-quality, innovative precision medicine solutions and bioanalytics for clinical development and diagnostic applications along with partners at Amsterdam University Medical Center (Amsterdam UMC), Erasmus Medical Center, and Radboud University Medical Center published a method validation study for monitoring acute myeloid leukemia (AML) measurable residual disease (MRD) by multiparametric flow cytometry (MFC) in accordance with AML European Leukemia Network and the United States Clinical Laboratory Standards Institute Guidelines. Navigate BioPharma provided critical expertise in assay validation, including method development, sample preparation, and data analysis. This study, published in the journal, Cytometry Part B: Clinical Cytometry (https://doi.org/10.1002/cyto.b.22144), addresses the stringent validation expectations for clinical use of MRD by MFC in AML patients to showcase how to meet rigorous standards for clinical decision-making where the underlying disease biology is fraught with variability, complexity and a scarcity of patient specimen. By demonstrating the methodology to overcome the obstacles associated with this difficult-to-address patient population, they hope to enable and empower other laboratories to be able to fulfill validation requirements more quickly, enabling these valuable decision-making tools to be more readily available to patients.

AML is a type of cancer that affects the blood and bone marrow. It is the most common type of leukemia in adults, and it is characterized by the rapid growth of abnormal white blood cells. AML is a serious disease, and the five-year survival rate is only about 25% in elderly patients. MRD is a small number of leukemic cells that remain in the body after treatment. The presence of MRD is a strong predictor of relapse, and MRD assessment is increasingly being used to guide treatment decisions for AML patients.

MFC is a powerful tool for MRD assessment requiring robust analytical validation to ensure accurate results are delivered. The assay developed by the study authors uses a panel of antibodies to identify and quantify leukemic cells in bone marrow and peripheral blood samples. The lab of Dr. Jacqueline Cloos at Amsterdam University Medical Center (Amsterdam UMC) together with the Dutch AML MRD Working Party played a pivotal role in establishing the clinical utility and bringing their extensive experience in AML MRD assessment to this study.

"This publication represents the importance of collaboration to tackle complex disease questions for patients." said Dr. Jacqueline Cloos, Amsterdam UMC.

"We are thrilled to have partnered with renowned experts in AML MRD assessment on this important project," said Kevin Nguyen, Director of High Throughput Clinical Trial Testing at Navigate BioPharma Services. "Their expertise in AML MRD assessment was invaluable to the validation of this MFC MRD assay."

About Navigate BioPharma

Navigate BioPharma Services, Inc., an independently operating subsidiary within the Novartis group of companies, is a leading provider of innovative biomarker and specialty bioanalytic solutions for clinical development and companion diagnostic applications. Over the past decade, Navigate BioPharma has built and developed its exclusive library of assays, methodologies, and biomarker solutions.  The company has a proven track record of success in developing and validating assays for a wide range of therapeutic and diagnostic applications. Their extensive expertise offers high-quality, accurate, and reliable solutions for its customers and partners to make informed decisions about drug development and patient care. For more information about Navigate BioPharma's services, please visit www.navigatebp.com or connect with them on LinkedIn at www.linkedin.com/company/navigatebp/.

• Media and Customer Contact information: To incorporate this new assay or any other proprietary Navigate technology in an upcoming clinical trial study contact: Nick Sanna, Head of Business Development & Strategic Alliances, Navigate BioPharma Services, Inc. Phone: (760) 602-1409. Email: [email protected].

SOURCE Navigate BioPharma Services, Inc.