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1. Reply

Author

Brabbing‐Goldstein, D., primary, Basel‐Salmon, L., additional, and Yaron, Y., additional

Published
2024
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2. Overall survival analysis of EXAM, a phase III trial of cabozantinib in patients with radiographically progressive medullary thyroid carcinoma

Author

Schlumberger, M, Elisei, R, Müller, S, Schöffski, P, Brose, M, Shah, M, Licitra, L, Krajewska, J, Kreissl, MC, Niederle, B, Cohen, EEW, Wirth, L, Ali, H, Clary, DO, Yaron, Y, Mangeshkar, M, Ball, D, Nelkin, B, and Sherman, S

Subjects
Cancer, Clinical Research, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Aged, Anilides, Carcinoma, Medullary, Diagnostic Imaging, Double-Blind Method, Female, Follow-Up Studies, Humans, International Agencies, Male, Prognosis, Pyridines, Survival Rate, Thyroid Neoplasms, cabozantinib, medullary thyroid cancer, progression-free survival, overall survival, RET M918T, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundPrimary analysis of the double-blind, phase III Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer (EXAM) trial demonstrated significant improvement in progression-free survival with cabozantinib versus placebo in patients with progressive medullary thyroid cancer (MTC). Final analysis of overall survival (OS), a key secondary endpoint, was carried out after long-term follow-up.Patients and methodsEXAM compared cabozantinib with placebo in 330 patients with documented radiographic progression of metastatic MTC. Patients were randomized (2:1) to cabozantinib (140 mg/day) or placebo. Final OS and updated safety data are reported.ResultsMinimum follow-up was 42 months. Kaplan-Meier analysis showed a 5.5-month increase in median OS with cabozantinib versus placebo (26.6 versus 21.1 months) although the difference did not reach statistical significance [stratified hazard ratio (HR), 0.85; 95% confidence interval (CI), 0.64-1.12; P = 0.24]. In an exploratory assessment of OS, progression-free survival, and objective response rate, cabozantinib appeared to have a larger treatment effect in patients with RET M918T mutation-positive tumors compared with patients not harboring this mutation. For patients with RET M918T-positive disease, median OS was 44.3 months for cabozantinib versus 18.9 months for placebo [HR, 0.60; 95% CI, 0.38-0.94; P = 0.03 (not adjusted for multiple subgroup analyses)], with corresponding values of 20.2 versus 21.5 months (HR, 1.12; 95% CI, 0.70-1.82; P = 0.63) in the RET M918T-negative subgroup. Median treatment duration was 10.8 months with cabozantinib and 3.4 months with placebo. The safety profile for cabozantinib remained consistent with that of the primary analysis.ConclusionThe secondary end point was not met in this final OS analysis from the trial of cabozantinib in patients with metastatic, radiographically progressive MTC. A statistically nonsignificant increase in OS was observed for cabozantinib compared with placebo. Exploratory analyses suggest that patients with RET M918T-positive tumors may experience a greater treatment benefit with cabozantinib.Trial registration numberNCT00704730.

Published
2017

3. Diagnostic Yield of Exome Sequencing in Prenatal Agenesis of Corpus Callosum: Systematic Review and Meta-Analysis

Author

Mustafa, H. J., Barbera, J. P., Sambatur, E. V., Pagani, G., Yaron, Y., Baptiste, C. D., Wapner, R. J., Brewer, C. J., Khalil, A., Mustafa, H. J., Barbera, J. P., Sambatur, E. V., Pagani, G., Yaron, Y., Baptiste, C. D., Wapner, R. J., Brewer, C. J., and Khalil, A.

Abstract

OBJECTIVES: To determine the incremental diagnostic yield of exome sequencing (ES) after negative chromosomal microarray analysis (CMA) in cases of prenatally diagnosed agenesis of the corpus callosum (ACC) and to identify the associated genes and variants. METHODS: A systematic search was performed to identify relevant studies published up until June 2022 using four databases: PubMed, SCOPUS, Web of Science and The Cochrane Library. Studies in English reporting on the diagnostic yield of ES following negative CMA in prenatally diagnosed partial or complete ACC were included. Authors of cohort studies were contacted for individual participant data and extended cohorts were provided for two of them. The increase in diagnostic yield with ES for pathogenic/likely pathogenic (P/LP) variants was assessed in all cases of ACC, isolated ACC, ACC with other cranial anomalies and ACC with extracranial anomalies. To identify all reported genetic variants, the systematic review included all ACC cases; however, for the meta-analysis, only studies with ≥ three ACC cases were included. Meta-analysis of proportions was employed using a random-effects model. Quality assessment of the included studies was performed using modified Standards for Reporting of Diagnostic Accuracy criteria. RESULTS: A total of 28 studies, encompassing 288 prenatally diagnosed ACC cases that underwent ES following negative CMA, met the inclusion criteria of the systematic review. We classified 116 genetic variants in 83 genes associated with prenatal ACC with a full phenotypic description. There were 15 studies, encompassing 268 cases, that reported on ≥ three ACC cases and were included in the meta-analysis. Of all the included cases, 43% had a P/LP variant on ES. The highest yield was for ACC with extracranial anomalies (55% (95% CI, 35-73%)), followed by ACC with other cranial anomalies (43% (95% CI, 30-57%)) and isolated ACC (32% (95% CI, 18-51%)). CONCLUSIONS: ES demonstrated an incremental diagnostic

Published
2024

4. Unique prenatal manifestations of biallelic NDUFAF5 variants: expansion of phenotype.

Author

Brabbing‐Goldstein, D., Kozlova, D., Bazak, L., Basel‐Salmon, L., Gilboa, Y., Marciano‐Levi, I., Zahra, J., Kanengisser‐Pines, B., Botvinik, A., Kurolap, A., Birnbaum, R., and Yaron, Y.

Subjects
HYDROPS fetalis, IODINE deficiency, FETAL growth retardation, FETAL tissues, HUMAN abnormalities, FETAL development, MITOCHONDRIAL pathology
Abstract

Objective: Mitochondrial complex‐I deficiency, nuclear type 16, is a rare autosomal recessive disorder caused by biallelic pathogenic variants in NDUFAF5 (C20orf7) (OMIM 618238). The aim of this study was to describe a severe early prenatal manifestation of this disorder, which was previously considered to occur only postnatally. Methods: This was a multicenter retrospective case series including five fetuses from three non‐related families, which shared common sonographic abnormalities, including brain cysts, corpus callosal malformations, non‐immune hydrops fetalis and growth restriction. Genetic evaluation included chromosomal microarray analysis and exome sequencing. Two fetuses from the same family were also available for pathology examination, including electron microscopy. Results: Chromosomal microarray analysis revealed no chromosomal abnormality in any of the tested cases. Trio exome sequencing demonstrated that three affected fetuses from three unrelated families were compound heterozygous or homozygous for likely pathogenic variants in NDUFAF5. No other causative variants were detected. The association between NDUFAF5 variants and fetal malformations was further confirmed by segregation analysis. Histological evaluation of fetal tissues and electron microscopy of the skeletal muscle, liver, proximal tubules and heart demonstrated changes that resembled postmortem findings in patients with mitochondrial depletion disorders as well as previously undescribed findings. Conclusions: Mitochondrial complex‐I deficiency and specifically biallelic mutations in NDUFAF5 have a role in abnormal fetal development, presenting with severe congenital malformations. Mitochondrial complex‐I disorders should be considered in the differential diagnosis of corpus callosal malformations and brain cysts, especially when associated with extracranial abnormalities, such as fetal growth restriction and non‐immune hydrops fetalis. © 2023 International Society of Ultrasound in Obstetrics and Gynecology. Linked article: There is a comment on this article by Finsterer. Click here to view the Correspondence. [ABSTRACT FROM AUTHOR]

Published
2024
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10. The WebDAV Property Design

Author

Whitehead, E J and Goland, Yaron Y

Subjects
metadata storage and retrieval, metadata design, WebDAV, Web authoring, document management
Abstract

This paper provides a detailed description of the general design space for metadata storage capabilities. The design space considers issues of metadata identification, typing and representation, dynamic behavior, predefined and user-defined metadata, schema discovery/update, operations, API packaging/marshalling, searching, and versioning. The design space is used to structure a retrospective analysis of the three major alternative metadata designs considered during the design of the WebDAV distributed authoring protocol. Deployment experience with WebDAV properties is also discussed, with the most successful use occurring in custom client/server pairs and in protocol extensions.

Published
2004

11. Reply

Author

Yaron, Y., primary and Krajden Haratz, K., additional

Published
2023
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12. EP18.14: The fetal brain in RASopathies: Noonan genes revisited.

Author

Leidner, N. Feldman, Miremberg, H., Izhar, E., Hartoov, J., Brusilov, M., Yaron, Y., Sira, L. Ben, Reches, A., Gull, I., Malinger, G., and Haratz, K. Krajden

Subjects
FETAL brain, FETAL imaging, FETAL echocardiography, FETAL MRI, PRENATAL diagnosis, POLYHYDRAMNIOS
Abstract

This article, titled "EP18.14: The fetal brain in RASopathies: Noonan genes revisited," explores the neurodevelopmental variability and brain imaging features of patients with RASopathies. The study focuses on describing the fetal brain and associated features of fetuses with confirmed RASopathies. The researchers conducted a retrospective study that included four patients with variants in RIT1, LZTR1, RRAS-2, and PTPN11. The findings highlight the range of features observed in fetal brain imaging and emphasize the importance of prenatal assessment for accurate diagnosis and counseling. [Extracted from the article]

Published
2024
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13. Exome sequencing as first‐tier test for fetuses with severe central nervous system structural anomalies

Author

Yaron, Y., primary, Ofen Glassner, V., additional, Mory, A., additional, Zunz Henig, N., additional, Kurolap, A., additional, Bar Shira, A., additional, Brabbing Goldstein, D., additional, Marom, D., additional, Ben Sira, L., additional, Baris Feldman, H., additional, Malinger, G., additional, Krajden Haratz, K., additional, and Reches, A., additional

Published
2022
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18. EP05.61: Expanding the KIDINS220/ARMS phenotype: heterozygous variant with fetal complex CNS anomaly.

Author

Miremberg, H., Birnbaum, R., Yaron, Y., Mory, A., Malinger, G., and Haratz, K. Krajden

Subjects
MULTIPLE pregnancy, GENETIC variation, ABORTION, SCAFFOLD proteins, NEUROENDOCRINE cells, AGENESIS of corpus callosum, DYSGENESIS
Abstract

This article discusses a case study involving a non-consanguineous Jewish couple who terminated a pregnancy due to multiple brain malformations. The couple sought genetic counseling, and trio exome sequencing revealed a heterozygous de-novo likely pathogenic variant in the KIDINS220 gene. This gene encodes a protein that plays a crucial role in embryonic neuronal differentiation and the maturation of axonal/dendritic processes. Heterozygous variants in KIDINS220 have been linked to a syndrome characterized by spastic paraplegia, intellectual disability, nystagmus, and obesity. The report emphasizes the importance of additional investigations in cases of non-isolated ventriculomegaly and expands the prenatal phenotype associated with KIDINS220 variants. [Extracted from the article]

Published
2024
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24. The VERNALIZATION 2 gene mediates the epigenetic regulation of vernalization in Arabidopsis

Author

Gendall, Anthony R., Levy, Yaron Y., Wilson, Allison, and Dean, Caroline

Subjects
Cell research -- Analysis, Arabidopsis -- Genetic aspects, Gene expression -- Physiological aspects, Zinc finger proteins -- Genetic aspects, Biological sciences
Abstract

Research has been conducted on the flowering acceleration caused by a long period of low temperature, vernalization. The study of the VERNALIZATION 2 gene which mediates vernalization and encodes a nuclear-localized zinc finger protein has been carried out and the results are discussed.

Published
2001

26. Immunohistochemical Performance of Estrogen and Progesterone Receptor Antibodies on the Dako Omnis Staining Platform: Evaluation in Multicenter Studies

Author

Leila Russo, David G. Hicks, Loralee McMahon, Mary Falzon, Kirsten D. Hoff, Patrizia Dell'Orto, Yaron Y. Levy, Keith W. Miller, and Giuseppe Viale

Subjects
0301 basic medicine, Pathology, medicine.medical_specialty, Histology, Clone (cell biology), Estrogen receptor, Breast Neoplasms, progesterone receptor, Antibodies, Pathology and Forensic Medicine, Random Allocation, 03 medical and health sciences, breast cancer, 0302 clinical medicine, Breast cancer, estrogen receptor-α, Progesterone receptor, Carcinoma, medicine, Humans, Research Articles, Staining and Labeling, business.industry, Gene Expression Profiling, Reproducibility of Results, medicine.disease, Immunohistochemistry, Staining, Medical Laboratory Technology, 030104 developmental biology, Receptors, Estrogen, 030220 oncology & carcinogenesis, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, Female, Receptors, Progesterone, Breast carcinoma, business, in vitro diagnostic medical devices
Abstract

Supplemental Digital Content is available in the text., The analysis of estrogen receptor (ER) and progesterone receptor (PR) expression levels by immunohistochemistry is an important part of the initial evaluation of breast cancer and critically important in treatment planning. Anti-ERα (clone EP1) and anti-PR (clone PgR 1294) antibodies are in development for the Dako Omnis automated staining platform. These antibodies are not yet commercially available and are in performance evaluation, including the 4 international, multicenter studies reported here. For each antibody, a reproducibility study and a method comparison study was done in a randomized manner in order to test the antibodies under conditions closest to real-world user conditions. The reproducibility studies included 5 staining runs on the Dako Omnis with 20 formalin-fixed and paraffin-embedded human breast carcinoma specimens in 3 independent laboratories, and the method comparison studies included several hundred specimens stained on the Dako Omnis and on the Autostainer Link 48 platforms. Stained slides were evaluated for nuclear ER or PR expression according to American Society of Clinical Oncology/College of American Pathologists guidelines (≥1% cut-off for positive) by pathologists who were blinded from the staining method and specimen ID. For both anti-ERα (clone EP1) and anti-PR (clone PgR 1294) on the Dako Omnis, high reproducibility agreement rates were obtained on the interrun, interlaboratory, and interobserver endpoints. High concordance rates were observed between the specimens stained on the Dako Omnis platform and the Autostainer Link 48 platform. Staining quality was excellent for both anti-ERα (clone EP1) and anti-PR (clone PgR 1294) on the Dako Omnis. These results suggest that these antibodies are reliable and reproducible tools for immunohistochemistry analysis of ER and PR expression levels in formalin-fixed and paraffin-embedded breast carcinoma tissues on the Dako Omnis platform.

Published
2017
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29. The genetic and clinical outcome of isolated fetal muscular ventricular septal defect (VSD)

Author

Svirsky, R., Brabbing-Goldstein, D., Rozovski, U., Kapusta, L., Reches, A., Yaron, Y., Svirsky, R., Brabbing-Goldstein, D., Rozovski, U., Kapusta, L., Reches, A., and Yaron, Y.

Abstract

Item does not contain fulltext, Introduction: Our objective was to evaluate the incidence of chromosomal aberration (both microscopic and submicroscopic) and the clinical outcome of fetuses with isolated muscular ventricular septal defect (VSD). Material and methods: The study included 40 pregnant women whose fetuses were diagnosed with isolated muscular ventricular septal defect (mVSD). Of these, 30 patients underwent amniocentesis and 10 declined. All samples were tested by chromosomal microarray analysis (CMA). Of the 40 women in the study, 32 gave birth and the clinical outcome of the children was retrieved from the patients' medical records. Results: Of the 30 patients who underwent amniocentesis, one was detected with mosaic Klinefelter syndrome and one was detected with a pathogenic copy number variant unrelated to the VSD. Clinical follow-up was performed on 26 children after birth. The first postnatal echocardiography did not detect a VSD in 13 (50%) of the followed-up children. Spontaneous closure occurred in another eight (30.8%) children during the postnatal follow-up period. In only five children (19.2%) VSD was still detected by echocardiography after the first year of life. Discussion: Isolated muscular VSD diagnosed prenatally does not appear to be a significant risk factor for chromosomal abnormalities and has a favorable clinical outcome.

Published
2019

30. WebDAV

Author

Whitehead, E. James, primary and Goland, Yaron Y., additional

Published
1999
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31. Assessment of HER2 amplification status in breast cancer using a new automated HER2 IQFISH pharmDx™ (Dako Omnis) assay

Author

Miriam Bloch, Patrizia Dell'Orto, Jennifer C. Paterson, Giuseppe Viale, Yaron Y. Levy, David Allen, Jan Trøst Jørgensen, Gitte Kjærsgaard, and George Csathy

Subjects
Receptor, ErbB-2, Breast Neoplasms, In situ hybridization, Biology, Pathology and Forensic Medicine, Automation, 03 medical and health sciences, Breast cancer, 0302 clinical medicine, HER2, medicine, Humans, HER2 Amplification, 030212 general & internal medicine, skin and connective tissue diseases, Human Epidermal Growth Factor Receptor 2, In Situ Hybridization, Fluorescence, medicine.diagnostic_test, Hybridization probe, Companion diagnostic, Gene Amplification, Reproducibility of Results, Cell Biology, medicine.disease, Molecular biology, Method comparison, 030220 oncology & carcinogenesis, IQFISH, %22">Fish , Female, Fluorescence in situ hybridization
Abstract

In breast cancer the human epidermal growth factor receptor 2 (HER2) is an important target for a number of different HER2 inhibitors. Different slide-based assays are available for assessment of treatment eligibility, which include fluorescence in situ hybridization (FISH) or other in situ hybridization (ISH) methods for assessment of the HER2 gene status. Here we report a summary of the validation data on HER2 IQFISH pharmDx™ (Dako Omnis), a newly developed assay for the automated staining platform Dako Omnis. The assay uses a non-toxic buffer that significantly reduces the hybridization time, which results in a total turnaround time of 3½ to 4h from deparaffinization to counting of the gene and centromere signals. The data reported in the current summary covers method comparison, assessment of staining quality, observer-to-observer reproducibility as well as reproducibility within and between laboratories. Based on data from the different studies it was concluded that HER2 IQFISH pharmDx (Dako Omnis) is a reliable and robust assay with a high precision that is at least comparable to the manual HER2 IQFISH pharmDx™ assay and the PathVysion® HER-2 DNA Probe Kit.

Published
2016
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32. Rapid centriole assembly inNaegleriareveals conserved roles for both de novo and mentored assembly

Author

Yaron Y. Levy, W. Zacheus Cande, Lillian K. Fritz-Laylin, Elaine Y. Lai, Edward Levitan, Sean Chen, and Chandler Fulton

Subjects
0301 basic medicine, education.field_of_study, Centriole, education, Population, Sequence assembly, Cell Biology, Biology, biology.organism_classification, Naegleria, Cell biology, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Structural Biology, Basal body, Eukaryote, Mitosis, 030217 neurology & neurosurgery, Centriole assembly
Abstract

Centrioles are eukaryotic organelles whose number and position are critical for cilia formation and mitosis. Many cell types assemble new centrioles next to existing ones ("templated" or mentored assembly). Under certain conditions, centrioles also form without pre-existing centrioles (de novo). The synchronous differentiation of Naegleria amoebae to flagellates represents a unique opportunity to study centriole assembly, as nearly 100% of the population transitions from having no centrioles to having two within minutes. Here, we find that Naegleria forms its first centriole de novo, immediately followed by mentored assembly of the second. We also find both de novo and mentored assembly distributed among all major eukaryote lineages. We therefore propose that both modes are ancestral and have been conserved because they serve complementary roles, with de novo assembly as the default when no pre-existing centriole is available, and mentored assembly allowing precise regulation of number, timing, and location of centriole assembly.

Published
2016
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47. Parental Origin of the Retained X Chromosome in Monosomy X Miscarriages and Ongoing Pregnancies

Author

Grande M, Stergiotou I, Pauta M, Marquès B, Badenas C, Soler A, Yaron Y, and Borrell A

Subjects
45,X, Karyotype, Miscarriages, Ongoing pregnancies, Parental origin, Retained X chromosome, Turner syndrome
Abstract

To assess the distribution of the parental origin of the retained X chromosome in monosomy X, either in miscarriages or in ongoing pregnancies.

Published
2017

48. Position statement from the Aneuploidy Screening Committee on behalf of the Board of the International Society for Prenatal Diagnosis

Author

Benn, P., Borell, A., Chiu, R., Cuckle, H., Dugoff, L., Faas, B.H., Gross, S., Johnson, J., Maymon, R., Norton, M., Odibo, A., Schielen, P., Spencer, K., Huang, T., Wright, D., and Yaron, Y.

Subjects
Genetics and epigenetic pathways of disease Genomic disorders and inherited multi-system disorders [NCMLS 6]
Abstract

Item does not contain fulltext

Published
2013
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49. Analysis of HER2 status in gastroesophageal tumor specimens using a new automated HER2 IQFISH pharmDx™ (Dako Omnis) assay

Author

Giuseppe, Viale, Jennifer, Paterson, Miriam, Bloch, George, Csathy, David, Allen, Patrizia, Dell'Orto, Gitte, Kjærsgaard, Yaron Y, Levy, and Jan Trøst, Jørgensen

Subjects
Observer Variation, Receptor, ErbB-2, Stomach Neoplasms, Gene Expression Profiling, Biomarkers, Tumor, Humans, Reproducibility of Results, Esophagogastric Junction, In Situ Hybridization, Fluorescence
Abstract

The human epidermal growth factor receptor 2 (HER2) is an important target for treatment of gastroesophageal cancer. Different slide-based assays are available for assessment of HER2 status. Overexpression of the HER2 protein is assessed by immunohistochemistry (IHC) whereas amplification of the HER2 gene is assessed by fluorescence in situ hybridization (FISH) or other in situ hybridization (ISH) methods. Here we report a summary of the validation data on HER2 IQFISH pharmDx™ (Dako Omnis), a newly developed assay for the automated staining platform Dako Omnis. This assay uses a non-toxic buffer that significantly reduces the hybridization time, which results in a total turnaround time of less than 4 hours from deparaffinization to counting of the gene and centromere signals. The data reported in the current summary cover method comparison, assessment of staining quality, observer-to-observer reproducibility as well as reproducibility within and between laboratories. Based on data from the different studies it was concluded that HER2 IQFISH pharmDx (Dako Omnis) is a reliable and robust assay, with high precision and at least comparable to the manual HER2 IQFISH pharmDx™ assay. The HER2 IQFISH pharmDx (Dako Omnis) assay is currently not commercially available outside the Europe Union.

Published
2016

50. Analysis of HER2 status in gastroesophageal tumor specimens using a new automated HER2 IQFISH pharmDx™ (Dako Omnis) assay

Author

Viale, Giuseppe, Paterson, Jennifer, Bloch, Miriam, Csathy, George, Allen, David, Dell’Orto, Patrizia, Kjærsgaard, Gitte, Levy, Yaron Y., and Trøst Jørgensen, Jan

Subjects
Automation, HER2, IQFISH, Companion diagnostic, 6 - Ciencias aplicadas::61 - Medicina::616 - Patología. Medicina clínica. Oncología [CDU], skin and connective tissue diseases, Gastric cancer, neoplasms
Abstract

The human epidermal growth factor receptor 2 (HER2) is an important target for treatment of gastroesophageal cancer. Different slide-based assays are available for assessment of HER2 status. Overexpression of the HER2 protein is assessed by immunohistochemistry (IHC) whereas amplification of the HER2 gene is assessed by fluorescence in situ hybridization (FISH) or other in situ hybridization (ISH) methods. Here we report a summary of the validation data on HER2 IQFISH pharmDx™ (Dako Omnis), a newly developed assay for the automated staining platform Dako Omnis. This assay uses a non-toxic buffer that significantly reduces the hybridization time, which results in a total turnaround time of less than 4 hours from deparaffinization to counting of the gene and centromere signals. The data reported in the current summary cover method comparison, assessment of staining quality, observer-to-observer reproducibility as well as reproducibility within and between laboratories. Based on data from the different studies it was concluded that HER2 IQFISH pharmDx (Dako Omnis) is a reliable and robust assay, with high precision and at least comparable to the manual HER2 IQFISH pharmDx™ assay. The HER2 IQFISH pharmDx (Dako Omnis) assay is currently not commercially available outside the European Union.

Published
2016

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