Manufacturing Cell and Gene Therapies: Challenges in Clinical Translation
This article addresses these potential challenges. Further, we discuss the use of the manufacturing model and its impact on cell and gene therapy.PMID:38361427 | DOI:10.3343/alm.2023.0382 (Source: Annals of Laboratory Medicine)
Source: Annals of Laboratory Medicine - February 16, 2024 Category: Laboratory Medicine Authors: Na Kyung Lee Jong Wook Chang Source Type: research
Direct LDL Cholesterol Assay vs. Estimated Equations in Patients With Hypertriglyceridemia or Low LDL Cholesterol Levels
Ann Lab Med. 2024 Jan 19. doi: 10.3343/alm.2023.0387. Online ahead of print.NO ABSTRACTPMID:38237928 | DOI:10.3343/alm.2023.0387 (Source: Annals of Laboratory Medicine)
Source: Annals of Laboratory Medicine - January 18, 2024 Category: Laboratory Medicine Authors: Jennifer Rodr íguez-Domínguez Álvaro Piedra-Aguilera Mar ía Martínez-Bujidos Susana Malumbres-Serrano Cristian Morales-Indiano Carla Fern ández-Prendes Source Type: research
Comparative Analysis of AB vs. ABO-specific Plasma for Desensitization in Blood Group O Recipients: An < em > In Vitro < /em > Study
Ann Lab Med. 2024 Jan 19. doi: 10.3343/alm.2023.0393. Online ahead of print.ABSTRACTNeutralizing capacity measurement (NCM) of soluble ABH substances (SAS) in plasma was assessed to guide the selection of the appropriate ABO group of fresh-frozen plasma (FFP) for plasma exchange (PE) in blood group O recipients with ABO-incompatible transplantations. Neutralizing capacity was assessed by measuring anti-A and/or anti-B titers in samples comprising one unit of O FFP and 10 O EDTA plasma samples and subtracting the binary logarithm of the titer in each group with a saline dilution. Ten EDTA plasma samples with Lewis b (Leb) a...
Source: Annals of Laboratory Medicine - January 18, 2024 Category: Laboratory Medicine Authors: Young Ae Lim Source Type: research
Comparison of Measurable Residual Disease in Pediatric B-Lymphoblastic Leukemia Using Multiparametric Flow Cytometry and Next-Generation Sequencing
Ann Lab Med. 2024 Jan 19. doi: 10.3343/alm.2023.0412. Online ahead of print.ABSTRACTMeasurable residual disease (MRD) testing, a standard procedure in B-lymphoblastic leukemia (B-ALL) diagnostics, is assessed using multiparametric flow cytometry (MFC) and next-generation sequencing (NGS) analysis of immunoglobulin gene rearrangements. We evaluated the concordance between eight-color, two-tube MFC-MRD the LymphoTrack NGS-MRD assays using 139 follow-up samples from 54 pediatric patients with B-ALL. We also assessed the effect of hemodilution in MFC-MRD assays. The MRD-concordance rate was 79.9% (N=111), with 25 (18.0%) and 3...
Source: Annals of Laboratory Medicine - January 18, 2024 Category: Laboratory Medicine Authors: Sang Mee Hwang Inseong Oh Seok Ryun Kwon Jee-Soo Lee Moon-Woo Seong Source Type: research
Clinical Practice Guideline for Blood-based Circulating Tumor DNA Assays
Ann Lab Med. 2024 May 1;44(3):195-209. doi: 10.3343/alm.2023.0389. Epub 2024 Jan 15.ABSTRACTCirculating tumor DNA (ctDNA) has emerged as a promising tool for various clinical applications, including early diagnosis, therapeutic target identification, treatment response monitoring, prognosis evaluation, and minimal residual disease detection. Consequently, ctDNA assays have been incorporated into clinical practice. In this review, we offer an in-depth exploration of the clinical implementation of ctDNA assays. Notably, we examined existing evidence related to pre-analytical procedures, analytical components in current techn...
Source: Annals of Laboratory Medicine - January 15, 2024 Category: Laboratory Medicine Authors: Jee-Soo Lee Eun Hye Cho Boram Kim Jinyoung Hong Young-Gon Kim Yoonjung Kim Ja-Hyun Jang Seung-Tae Lee Sun-Young Kong Woochang Lee Saeam Shin Eun Young Song Clinical Practice Guidelines Committee of the Korean Society for Laboratory Medicine Source Type: research
Association Between Aortic Valve Sclerosis and Clonal Hematopoiesis of Indeterminate Potential
CONCLUSIONS: Participants with AVS more commonly had larger CHIP clones than age- and sex-matched controls. Further studies are warranted to identify causality between AVS and CHIP.PMID:38205526 | PMC:PMC10813825 | DOI:10.3343/alm.2023.0268 (Source: Annals of Laboratory Medicine)
Source: Annals of Laboratory Medicine - January 11, 2024 Category: Laboratory Medicine Authors: Minkwan Kim Jin Ju Kim Seung-Tae Lee Yeeun Shim Hyeonah Lee SungA Bae Nak-Hoon Son Saeam Shin In Hyun Jung Source Type: research
Current Challenges in Chimeric Antigen Receptor T-cell Therapy in Patients With B-cell Lymphoid Malignancies
Ann Lab Med. 2024 May 1;44(3):210-221. doi: 10.3343/alm.2023.0388. Epub 2024 Jan 11.ABSTRACTChimeric antigen receptor (CAR) T-cell therapy is a promising immunotherapy based on genetically engineered T cells derived from patients. The introduction of CAR T-cell therapy has changed the treatment paradigm of patients with B-cell lymphoid malignancies. However, challenging issues including managing life-threatening toxicities related to CAR T-cell infusion and resistance to CAR T-cell therapy, leading to progression or relapse, remain. This review summarizes the issues with currently approved CAR T-cell therapies for patients...
Source: Annals of Laboratory Medicine - January 11, 2024 Category: Laboratory Medicine Authors: Seok Jin Kim Sang Eun Yoon Won Seog Kim Source Type: research
Optimization of a Protocol for Isolating Cell-free DNA From Cerebrospinal Fluid
Ann Lab Med. 2024 May 1;44(3):294-298. doi: 10.3343/alm.2023.0267. Epub 2023 Dec 28.ABSTRACTA standardized protocol for the isolation of cell-free DNA (cfDNA) from cerebrospinal fluid (CSF) is lacking. Therefore, we established a cfDNA isolation protocol optimized for clinical CSF specimens, integrating acceptable modifications and using artificial CSF generated from remnant CSF spiked with reference cell-free tumor DNA (ctDNA). We compared the isolation yields of in vitro diagnostic (IVD)-certified column-based (CB) and magnetic bead-based (MB) isolation. Furthermore, we modified both methods, including pre- and post-elut...
Source: Annals of Laboratory Medicine - December 28, 2023 Category: Laboratory Medicine Authors: Ho Hyun Song Hyeran Park Doohwan Cho Hae In Bang Hyuk-Jin Oh Jieun Kim Source Type: research
Twins With an Identical Novel Mutation in < em > ITGB3 < /em > : A Case Report of Glanzmann Thrombasthenia-like Syndrome
Ann Lab Med. 2024 May 1;44(3):299-302. doi: 10.3343/alm.2023.0375. Epub 2023 Dec 28.NO ABSTRACTPMID:38151855 | PMC:PMC10813824 | DOI:10.3343/alm.2023.0375 (Source: Annals of Laboratory Medicine)
Source: Annals of Laboratory Medicine - December 28, 2023 Category: Laboratory Medicine Authors: Jaewoong Lee Jong-Mi Lee Hoon Seok Kim Jin Jung Yonggoo Kim Suk Young Park Myungshin Kim Eunhee Han Source Type: research
Optimization of a Protocol for Isolating Cell-free DNA from Cerebrospinal Fluid
Ann Lab Med. 2023 Dec 28. doi: 10.3343/alm.2023.0267. Online ahead of print.ABSTRACTA standardized protocol for the isolation of cell-free DNA (cfDNA) from cerebrospinal fluid (CSF) is lacking. Therefore, we established a cfDNA isolation protocol optimized for clinical CSF specimens, integrating acceptable modifications and using artificial CSF generated from remnant CSF spiked with reference cell-free tumor DNA (ctDNA). We compared the isolation yields of in vitro diagnostic (IVD)-certified column-based (CB) and magnetic bead-based (MB) isolation. Furthermore, we modified both methods, including pre- and post-elution step...
Source: Annals of Laboratory Medicine - December 28, 2023 Category: Laboratory Medicine Authors: Ho Hyun Song Hyeran Park Doohwan Cho Hae In Bang Hyuk-Jin Oh Jieun Kim Source Type: research
Twins With an Identical Novel Mutation in < em > ITGB3 < /em > : A Case Report of Glanzmann Thrombasthenia-like Syndrome
Ann Lab Med. 2023 Dec 28. doi: 10.3343/alm.2023.0375. Online ahead of print.NO ABSTRACTPMID:38151855 | DOI:10.3343/alm.2023.0375 (Source: Annals of Laboratory Medicine)
Source: Annals of Laboratory Medicine - December 28, 2023 Category: Laboratory Medicine Authors: Jaewoong Lee Jong-Mi Lee Hoon Seok Kim Jin Jung Yonggoo Kim Suk Young Park Myungshin Kim Eunhee Han Source Type: research
Optimization of a Protocol for Isolating Cell-free DNA from Cerebrospinal Fluid
Ann Lab Med. 2023 Dec 28. doi: 10.3343/alm.2023.0267. Online ahead of print.ABSTRACTA standardized protocol for the isolation of cell-free DNA (cfDNA) from cerebrospinal fluid (CSF) is lacking. Therefore, we established a cfDNA isolation protocol optimized for clinical CSF specimens, integrating acceptable modifications and using artificial CSF generated from remnant CSF spiked with reference cell-free tumor DNA (ctDNA). We compared the isolation yields of in vitro diagnostic (IVD)-certified column-based (CB) and magnetic bead-based (MB) isolation. Furthermore, we modified both methods, including pre- and post-elution step...
Source: Annals of Laboratory Medicine - December 28, 2023 Category: Laboratory Medicine Authors: Ho Hyun Song Hyeran Park Doohwan Cho Hae In Bang Hyuk-Jin Oh Jieun Kim Source Type: research
