MSK-IMPACT® Flex powered with SOPHiA DDM™

Elevate your comprehensive genomic profiling
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Flexible CGP analysis without compromise

Achieve scalable analysis of solid tumors with an agile and modular approach to comprehensive genomic profiling (CGP), eliminating the need for multiple tests.

Built on the expert-designed content of MSK-IMPACT® and combined with the adaptive analytics of the SOPHiA DDM™ Platform, MSK-IMPACT® Flex powered with SOPHiA DDM™ delivers high-resolution profiling of complex biomarkers from DNA and RNA in a single, end-to-end workflow.

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Expert content design

Built on the backbone of MSK-IMPACT®, curated by Memorial Sloan Kettering Cancer Center (MSK) experts and verified in over 1,000 MSK publications.

In-depth CNV detection
Leverage high resolution CNV profiling for deep insights into whole gene amplifications, deletions, and exon-level CNVs.
Comprehensive profiling

Detect all major variant classes (SNVs/Indels, CNVs, partner-agnostic fusions, exon-skipping events, gene expression) and complex signatures (TMB, MSI, HRD).

Maximized lab efficiency
Reduce hands-on time by eliminating send-outs and covering DNA and RNA analysis in a single, automated workflow.
Modular analysis
Robust CYP2D6 assessment

Add RNA and HRD analysis at the sample level to tailor biomarker coverage for each case, optimizing cost efficiency.

Enhanced interpretation
Match molecular profiles with biologically actionable information on diagnosis, prognosis, treatments, and clinical trials with OncoPortal™ Knowledge Base.

Streamline your workflow

Boost lab efficiency with a single, streamlined, end-to-end NGS workflow that allows you to analyze multiple data modalities in one sequencing run. All variant detection and interpretation steps are powered by the SOPHiA DDM™ Platform, giving you full control over your data and samples.

Easy library preparation and capture
  • 146 gene panel focused on actionability, curated by MSK experts and selected from MSK’s cancer genomic profiling assay, MSK-IMPACT®
  • Hybridization-based capture with deep sequencing (~20,000x)
  • Tailored probes for high on-target rate and coverage uniformity
  • Minimal input amount of only 20 ng cfDNA
  • Ready-to-sequence libraries in just 1.5 days
  • Optimized multiplexing of paired tumor-normal samples for a cost-effective process
  • Compatible with NovaSeq™ 6000 and NextSeq® 2000 sequencers
Advanced analysis with the SOPHiA DDM™ Platform
  • Algorithm-powered detection of SNVs, Indels, CNV, and fusions
  • Proprietary unique molecular identifier (UMI) technology, CUMIN™, for sensitive variant detection down to 0.5% VAF
  • Tumor-informed variant calling to facilitate follow-ups and decision-making
  • Tertiary analysis based on the latest scientific evidence on relevant variants with OncoPortal™ Plus​
  • Access to MSK’s Precision Oncology Knowledge Base, OncoKB™, via link-out at gene level for enhanced interpretation support
  • Knowledge-sharing within SOPHiA GENETICS Community, one of the largest networks of connected healthcare institutions
You won’t be left alone.
Enjoy comprehensive support at every step through the SOPHiA DDM™ MaxCare Program, making in-house adoption a breeze.

Advancing precision oncology – your way

The modular architecture of the SOPHiA DDM™ Platform enables a truly flexible approach to CGP. You can easily integrate analytical modules – RNA analysis and/or low-pass whole genome sequencing–based HRD detection – at the sample level to meet the specific needs of your institution and deliver the most relevant insights for every case.

Take your research further by complementing your tissue analysis with SOPHiA DDM™ for Liquid Biopsy, enabling advanced monitoring of resistance and a comprehensive view of the tumor landscape.

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Application Specifications

No. of genes • 533 DNA genes (including 505 from MSK-IMPACT®)
• 140 RNA genes
Disease covered Multi-cancer (any solid tumor)
Sample type FFPE, fresh frozen
Recommended input amount • 50 ng DNA
• 50 ng RNA
Sequencer compatibility • Illumina® NextSeq® 550/1000/2000
• Illumina® NovaSeq™ 6000, X
• Compatible with MGI and Element sequencers – SOPHiA DDM™ MaxCare Program is recommended to verify performance
Detected variants & biomarkers From DNA
• SNVs/Indels in 533 genes
• Whole gene amplifications and deletions in 520 genes
• Gene-level and exon-level CNVs in 49 genes
• TERT promoter
• TMB
• MSI
• HRD (optional)
From RNA (optional)
• Partner-agnostic fusions in 135 genes
• Exon skipping events in 9 genes
• Gene expression in 56 genes
Limit of detection at 95% (LOD95) 5%
Recommended paired-end reads • DNA capture – 51 million
• RNA capture – 11 million
• DNA whole genome sequencing (at ~1x coverage) – 20 million
Library preparation time • 1.5 days (DNA only)
• 2.5 days (DNA+RNA)
Analysis time* DNA only – <10 hours
DNA + RNA – <15 hours

*Analysis time dependent on multiplexing and server load.

Comparison Table Heading

  SOPHiA DDM™ HCS v1.1 (RUO) SOPHiA DDM™ HCS v2.0 (RUO) SOPHiA DDM™ Dx HCS (CE-IVD)
Diseases covered Hereditary Breast and Ovarian Cancer (HBOC), Lynch and various intestinal polyposis syndromes Breast, ovarian, prostate, abdominal, endocrine & neuroendocrine, nervous system, renal, and skin Breast and ovarian cancers and colorectal syndromes
Diseases covered 26 + PMS2CL 82 + PMS2CL 26 + PMS2CL
Target region size 105 kb 285 kb 105 kb
Sample type Blood Blood Blood
DNA input amount 200 ng 50 ng 200 ng
Sequence
  • Illumina MiniSeq™, MiSeq®, NextSeq® 500/550
  • Thermo Fisher Scientific Ion Proton™, Ion S5™
  • MGI DNBSEQ-G400
  • Illumina MiSeq®,  NextSeq® 500/550, NextSeq® 1000/2000
  • MGI DNBSEQ-G400
  • Illumina MiSeq®
Library prep time 1.5 days 1.5 days 2 days
Analysis time from FASTQ 4 hours 4 hours < 6 hours
Detected variants
  • SNVs
  • Indels
  • CNVs
  • Alu insertions
  • PMS2vsPMS2CLvariants
  • Boland inversion
  • SNVs
  • Indels
  • CNVs
  • Aluinsertions
  • PMS2 vs PMS2CL variants
  • Boland inversion
  • SNVs
  • Indels
  • CNVs (Clinical Decision Support only)
  • PMS2 vs PMS2CL variants (Clinical Decision Support only)

Want to accurately distinguish somatic from germline variants?

Explore the matched tumor-normal workflow of MSK-IMPACT® powered with SOPHiA DDM™ to reveal the true origin of variants.

SOPHiA GENETICS products are for Research Use Only and not for use in diagnostic procedures unless specified otherwise.

SOPHiA DDM™ Dx Hereditary Cancer Solution, SOPHiA DDM™ Dx RNAtarget Oncology Solution and SOPHiA DDM™ Dx Homologous Recombination Deficiency Solution are available as CE-IVD products for In Vitro Diagnostic Use in the European Economic Area (EEA), the United Kingdom and Switzerland. SOPHiA DDM™ Dx Myeloid Solution and SOPHiA DDM™ Dx Solid Tumor Solution are available as CE-IVD products for In Vitro Diagnostic Use in the EEA, the United Kingdom, Switzerland, and Israel. Information 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 us to obtain the appropriate product information for your country of residence.

All third-party trademarks listed by SOPHiA GENETICS remain the property of their respective owners. Unless specifically identified as such, SOPHiA GENETICS’ use of third-party trademarks does not indicate any relationship, sponsorship, or endorsement between SOPHiA GENETICS and the owners of these trademarks. Any references by SOPHiA GENETICS to third-party trademarks is to identify the corresponding third-party goods and/or services and shall be considered nominative fair use under the trademark law.

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