SOPHiA GENETICS Launches MSK-IMPACT® powered with SOPHiA DDM™ at AMP 2024

Rhea-AI Summary

SOPHiA GENETICS (SOPH) has globally launched MSK-IMPACT® powered with SOPHiA DDM™, a comprehensive genomic profiling application developed in collaboration with Memorial Sloan Kettering Cancer Center. The solution enables organizations worldwide to access advanced tumor profiling technologies with high accuracy and efficiency. The platform demonstrates exceptional performance with 99.3% positive agreement for SNV/Indel detection and 94.6% for CNV detection. SOFIVA GENOMICS in Taiwan is among the first adopters, expanding their tumor profiling capabilities. The workflow takes approximately five days from DNA extraction to final report, integrating OncoKB™ for enhanced analytical insights.

Positive

• High accuracy validation results: 99.3% agreement for SNV/Indel detection
• Efficient workflow completion in approximately 5 days
• Integration with MSK's OncoKB™ knowledge base enhancing analytical capabilities
• Early adoption by SOFIVA GENOMICS demonstrates market traction

Negative

• None.

Insights

Medical Research Analyst

The launch of MSK-IMPACT® powered with SOPHiA DDM™ represents a significant advancement in precision oncology diagnostics. The platform's impressive validation metrics, including 99.3% concordance for SNV/Indel detection and 94.6% for CNV detection, demonstrate robust technical performance. The integration with OncoKB™ and five-day turnaround time positions this as a competitive offering in the comprehensive genomic profiling market.

The platform's ability to enhance MTAP gene detection accuracy is particularly noteworthy, as MTAP deletions are emerging as important biomarkers for targeted therapies. The matched tumor-normal analysis approach significantly reduces false positives in somatic mutation detection, addressing a critical challenge in cancer diagnostics. The expansion into Taiwan through SOFIVA GENOMICS indicates strong commercial potential in the Asian market.

Market Research Analyst

This product launch strengthens SOPHiA GENETICS' market position in the growing precision oncology space. The partnership with Memorial Sloan Kettering Cancer Center, a prestigious institution, adds significant credibility and market value. The platform's global accessibility and decentralized approach could drive substantial market penetration, particularly in underserved regions.

The expansion of SOFIVA GENOMICS' adoption from HRD testing to include both MSK-IMPACT® and MSK-ACCESS® demonstrates successful product ecosystem development and customer retention. The platform's network effect, generating collective intelligence from diverse populations, creates a sustainable competitive advantage and potential for recurring revenue growth through data insights.

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

BOSTON and ROLLE, Switzerland, Nov. 21, 2024 /PRNewswire/ -- 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, M.D., 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.

SOPHiA GENETICS Forward-Looking Statements:
This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business strategy, products, and technology, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements are based on our management's beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this press release speak only as of the date hereof. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based, unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

 

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SOURCE SOPHiA GENETICS

FAQ

What are the accuracy rates of MSK-IMPACT powered with SOPHiA DDM?

The platform achieved 99.3% positive percent agreement for SNV/Indel detection, 94.6% for CNV detection, 99.4% for MSI detection, and 98.8% for TMB detection.

How long does the MSK-IMPACT powered with SOPHiA DDM analysis process take?

The entire process from DNA extraction to final report takes approximately five days.

Who is the first major adopter of SOPHiA GENETICS' MSK-IMPACT platform?

SOFIVA GENOMICS, a leading molecular diagnostics company in Taiwan, is among the first to adopt this application.

What features does SOPHiA GENETICS' MSK-IMPACT platform include?

The platform includes matched tumor-normal analysis, somatic mutation detection, access to OncoKB™ knowledge base, and integration with the SOPHiA DDM™ Platform for comprehensive genomic profiling.