Launch of new application enables global access to highly recognized solid tumor profiling assay

BOSTON and ROLLE,Switzerland,Nov. 21,2024 -- SOPHiA GENETICS (Nasdaq: SOPH),a cloud-native healthcare technology leader in data-driven medicine,announced the global launch of MSK-IMPACT® powered with SOPHiA DDM™ today from the Association for Molecular Pathology (AMP) Annual Meeting. This innovative solution provides organizations worldwide with the opportunity to benefit from Memorial Sloan Kettering Cancer Center (MSK)'s best-in-class comprehensive genomic profiling (CGP) application on the SOPHiA DDM™ Platform with high accuracy and efficiency.

"The launch of MSK-IMPACT® powered with SOPHiA DDM™ is another major milestone in our journey to expand access to precision oncology globally and demonstrates our commitment to democratizing data-driven medicine," said Philippe Menu,M.D.,PhD.,Chief Product Officer and Chief Medical Officer,SOPHiA GENETICS. "Following the successful launch of MSK-ACCESS® powered with SOPHiA DDM™ earlier this year,we are incredibly excited to further build on our excellent collaboration with MSK. Launching this application is a powerful step in our vision to decentralize access to advanced tumor profiling technologies,making these capabilities more widely available,especially in underserved populations."

Kojo S. J. Elenitoba-Johnson,Chair of the Department of Pathology and Lab Medicine at MSK,added,"We share a vision with SOPHiA GENETICS to advance precision medicine and to make our leading tests more accessible to patients around the world."

Through MSK-IMPACT® powered with SOPHiA DDM™,organizations can process more precise oncology analysis by enhancing the accuracy of somatic mutation detection,including in genes that are highly relevant for the current pharmaceutical industry R&D pipelines,such as MTAP. The matched tumor-normal analysis approach allows clinicians and researchers to detect somatic mutations more confidently,minimizing the risk of misclassifying germline variants as tumor-specific. Additionally,institutions benefit from the global collective intelligence created by SOPHiA GENETICS' network,allowing users to contribute to and draw from a continuously evolving base of real-world data and insights from diverse populations.

SOFIVA GENOMICS,a leading molecular diagnostics company in Taiwan,is among the first to adopt this application. The company initially partnered with SOPHiA GENETICS in 2022 to utilize the SOPHiA DDM™ Homologous Recombination Deficiency (HRD) Solution. Now,SOFIVA GENOMICS is expanding its tumor profiling capabilities by adding MSK-IMPACT® powered with SOPHiA DDM™ alongside the liquid biopsy test MSK-ACCESS® powered with SOPHiA DDM™.

Chia-Cheng Hung,General Manager,SOFIVA GENOMICS,commented,"Our partnership with SOPHiA GENETICS has greatly enhanced our ability to provide localized,highly accurate genomic testing. Access to this advanced technology enables us to bring advanced,trusted capabilities and further our progress on cancer research in Taiwan."

MSK-IMPACT® powered with SOPHiA DDM™ enables a more efficient workflow,with the entire process from DNA extraction to final report taking approximately five days. Clinicians and researchers benefit from access to OncoKB™,MSK's Precision Oncology Knowledge Base,which further enhances the interpretive power of the SOPHiA DDM™ analysis through data-driven,actionable insights. In-house analytical validation results for MSK-IMPACT® powered with SOPHiA DDM™ showed high concordance to the single-site MSK-IMPACT® test,achieving:

99.3% positive percent agreement (PPA) for SNV/Indel detection

94.6% PPA for copy number variant (CNV) detection

99.4% overall percent agreement (OPA) for microsatellite instability (MSI) detection

98.8%OPA for tumor mutational burden (TMB) detection.

For more information on SOPHiA GENETICS,visit SOPHiAGENETICS.com,or connect on LinkedIn.

About SOPHiA GENETICS

SOPHiA GENETICS (Nasdaq: SOPH) is a cloud-native healthcare technology company on a mission to transform patient care by expanding access to data-driven medicine globally. It is the creator of the SOPHiA DDM™ Platform,which analyzes complex genomic and multimodal data and generates real-time,actionable insights for a broad global network of hospital,laboratory,and biopharma institutions. For more information,visit SOPHiAGENETICS.com and connect with us on LinkedIn.

SOPHiA GENETICS products are for Research Use Only and not for use in diagnostic procedures unless specified otherwise. The information in this press release is about products that may or may not be available in different countries and,if applicable,may or may not have received approval or market clearance by a governmental regulatory body for different indications for use. Please contact support@sophiagenetics.com to obtain the appropriate product information for your country of residence. Concordance results based on analytic assessment of RUO products.

Memorial Sloan Kettering (MSK) has institutional financial interests related to SOPHiA GENETICS.

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