Novel Point-of-Care Test for the Early Detection of Acute Promyelocytic Leukemia
Abstract
The project will address the Fiscal Year 2020 (FY20) Peer Reviewed Cancer Research Program (PRCRP) Topic Area “Blood Cancers.” Acute Promyelocytic Leukemia (APL) accounts for approximately 5%-8% of the 20,000 Acute Myeloid Leukemia (AML) cases per year in the United States. APL can occur at any age, but the median age is 40 years, younger than the 70 years for other AMLs. Untreated APL rapidly (1-3 days) produces lung or brain hemorrhage in 40% of patients, faster than turn-around times for current “gold standard” DNA diagnostics, even in major medical centers (2-14 days). Clinicians in many major medical centers have endeavored to develop in-house rapid APL confirmatory tests to complement the slower gold standard tests. We propose to develop an on-site rapid, easily interpretable, diagnostic test for APL to facilitate the prompt diagnosis of APL and initiation of the known, life-saving all-trans retinoic acid therapy. We propose a 30-minute sample prep and lateral-flow assay (LFA; like the home pregnancy test or rapid flu test) for detecting the characteristic APL protein in blood to enable prompt diagnosis and treatment. To address the unmet need for rapid diagnosis of APL, we have assembled a strong interdisciplinary team consisting of engineers, scientists, biostatisticians, and physicians with complementary expertise in antibody-based technologies, point-of-care diagnostic methods, technology translation, hematopoietic disorders, and cancer pathology. The rationale is that our extremely-sensitive, rapid immunophage LFA technology can serve as a genuinely useful on-site APL diagnostic. Widespread availability will be assured by low cost (less than $30), long shelf life (at least 1 year), and moderate complexity of the test and its associated sample preparation and interpretation. Clinically, the technology will have an immediate impact by enabling on-site diagnosis of APL, minimizing the delay before initiation of the known, life-saving therapy. Our long-term goal is to develop a platform technology of general applicability in medical diagnostics and biomedical research by integrating our immuno-phage lateral-flow assay technology with POC sample prep methods. The proposed work directly addresses the FY20 PRCRP Military Health Focus Area of Mission Readiness “Gaps in cancer prevention, early detection/diagnosis, prognosis, and/or treatment that may impact mission readiness and the health and well-being of military members, Veterans, their beneficiaries, and the general public,” among others. Blood cancers represent some of the more common cancer types and specifically the higher prevalence of APL in young adults makes it highly relevant for Service Members and their families. Successful completion of the project will not only benefit the health and welfare of military Service Members, but also the American public. This research has the potential to change the paradigm in clinical diagnosis of APL.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 05, 2021
- Source ID
- W81XWH2110975
Entities
People
- Katerina Kourentzi
Organizations
- United States Army
- University of Houston