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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

Evaluation of Navify Mutation Profiler Tertiary Analysis Software Assessing for Hematologic Malignancies †

by
Ruby Singhrao
,
Michael J. Clark
,
Shikha Chugh
,
Lisha Capucion
,
Shuba Krishna
,
Ranga Yerram
,
Lili Niu
,
Adama Parham
,
Amy Harrell
,
John Duncan
,
Kristina Clark
and
Manana Javey
*
Roche Diagnostic Solutions, Pleasanton, CA 94588, USA
*
Author to whom correspondence should be addressed.
†
This paper is an extended version of our poster presented at the Roche Sponsored 2025 Tucson Symposium, Tucson, AZ, USA, 1–2 April 2025, a copy of which can be found on the Roche Medically site (https://ter.li/m7mp4l).
J. Mol. Pathol. 2025, 6(2), 9; https://doi.org/10.3390/jmp6020009
Submission received: 11 March 2025 / Revised: 6 May 2025 / Accepted: 14 May 2025 / Published: 22 May 2025
Versions Notes

Abstract

Background: Navify® Mutation Profiler (Navify MP) is a cloud-based, tertiary analysis software that provides curation, annotation, and reporting of somatic genomic alterations and biomarker signatures identified by next-generation sequencing. The Navify MP software leverages Association for Molecular Pathology/American Society of Clinical Oncology/College of American Pathologists (AMP/ASCO/CAP) Somatic Variant Classification Guidelines to provide information on detected somatic genomic variants and associated therapies according to region-specific approvals. Methods: This validation study assessed the accuracy of the Navify MP software and curation process for hematologic malignancies as compared to expert opinion. A total of 86 variants derived from hematologic malignancies (including myeloid and lymphoid leukemias, B cell lymphomas, and multiple myeloma) were used to contrive 12 VCF files. The VCFs were made up of the following classes of genomic alterations: single nucleotide variants, small insertions and deletions, fusions, and copy number alterations. Of the 86 variants, 42 were Tier IA, and 44 were non-Tier IA, based on AMP/ASCO/CAP classification. The study was performed at four sites with seven software users (molecular genetics experts). Results: Tier classification agreement between Navify MP and expert user assignment was 91.34% for Tier IA and 95.02% across all hematologic variants. The agreement on associated therapies for the Navify MP-classified Tier IA hematologic variants was 99.08%. Conclusion: Navify MP is a robust automated solution for genomic variant reporting of hematologic malignancies and remains up to date with evolving regional approvals and medical guidelines.
Keywords: hematologic malignancies; genomic variant reporting; therapeutic annotations; heme variants; tertiary analysis; clinical decision support; next-generation sequencing; genomic analysis software hematologic malignancies; genomic variant reporting; therapeutic annotations; heme variants; tertiary analysis; clinical decision support; next-generation sequencing; genomic analysis software

Share and Cite

MDPI and ACS Style

Singhrao, R.; Clark, M.J.; Chugh, S.; Capucion, L.; Krishna, S.; Yerram, R.; Niu, L.; Parham, A.; Harrell, A.; Duncan, J.; et al. Evaluation of Navify Mutation Profiler Tertiary Analysis Software Assessing for Hematologic Malignancies. J. Mol. Pathol. 2025, 6, 9. https://doi.org/10.3390/jmp6020009

AMA Style

Singhrao R, Clark MJ, Chugh S, Capucion L, Krishna S, Yerram R, Niu L, Parham A, Harrell A, Duncan J, et al. Evaluation of Navify Mutation Profiler Tertiary Analysis Software Assessing for Hematologic Malignancies. Journal of Molecular Pathology. 2025; 6(2):9. https://doi.org/10.3390/jmp6020009

Chicago/Turabian Style

Singhrao, Ruby, Michael J. Clark, Shikha Chugh, Lisha Capucion, Shuba Krishna, Ranga Yerram, Lili Niu, Adama Parham, Amy Harrell, John Duncan, and et al. 2025. "Evaluation of Navify Mutation Profiler Tertiary Analysis Software Assessing for Hematologic Malignancies" Journal of Molecular Pathology 6, no. 2: 9. https://doi.org/10.3390/jmp6020009

APA Style

Singhrao, R., Clark, M. J., Chugh, S., Capucion, L., Krishna, S., Yerram, R., Niu, L., Parham, A., Harrell, A., Duncan, J., Clark, K., & Javey, M. (2025). Evaluation of Navify Mutation Profiler Tertiary Analysis Software Assessing for Hematologic Malignancies. Journal of Molecular Pathology, 6(2), 9. https://doi.org/10.3390/jmp6020009

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