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Targeted Panel Assays:

Plasma-Safe-SeqS (PSS) Technology

HNSCC-SEQ:

Reliable detection of clinically relevant mutations in HPV-negative HNSCC

AML-SEQ™ :

Ultra-sensitive detection of the most common Acute Myeloid Leukemia (AML) biomarkers with maximum efficiency.

AML-MRD-SEQ:

Reliable detection of AML-MRD relevant and promising mutations. AML-MRD-SEQ detects 68 mutations across 20 genes, including established AML markers, such as IDH1, IDH2, and NPM1, and it demonstrates a significant potential for use as an investigational tool for other markers with prognostic values that are not yet well established.

RAS-RAF-SEQ:

Detection of mutations in the five most relevant targets for cancers (e.g., colorectal, pancreatic, gallbladder, ovarian, and lung) impacted by the RAS-RAF and PI3K signaling pathways.

BC-SEQ:

BC-SEQ detects mutations in established and emerging predictive markers, resistance mutations, and frequently occurring genetic alterations in breast cancer.

Plasma-Safe-SeqS panel Clinically relevant gene regions Intended uses
RAS-RAF-SEQ RAS-RAF Pathway BRAF, KRAS, NRAS, AKT1, PIK3CA
  • Therapy selection
  • Therapeutic monitoring
  • HPV-SEQ & HPV Pathway HPV 16, HPV 18
  • Therapy selection
  • Therapeutic monitoring
  • Recurrence surveillance
  • BC-SEQ & Breast Cancer AKT1, ERBB2, ESR1, KRAS, PIK3CA, TP53
  • Therapy selection
  • Therapeutic monitoring
  • Recurrence surveillance
  • AML-MRD-SEQ & AML MRD FLT3, IDH1, IDH2, NPM1, BCOR, BRAF, CEBPA, GATA2, JAK2, KIT, KRAS, NRAS, PRPF8, PTPN11, SETBP1, SF3B1, SRSF2, TP53, U2AF1, ZRSR2
  • Therapy selection
  • Therapeutic monitoring
  • MRD detection
  • Recurrence surveillance
  • HNSCC-SEQ & H&N HPV(-) cancers CDKN2A, EGFR, ERBB2, FGFR3, HRAS, KRAS, NOTCH1, PIK3CA, PTEN, TP53
  • Therapy selection
  • Therapeutic monitoring
  • Recurrence surveillance
  • Plasma-Safe-SeqS technology platform general test specifications
    Cell-free DNA analysis for solid tumors Hematological malignancies
    Sample types
    accepted
    • Whole blood
    • Frozen plasma
    • Purified cfDNA
    • Whole blood
    • Purified DNA isolated from bone barrow or blood
    • Purified cfDNA
    Sample
    requirements
    • 2x10 mL blood collection tubes required, additional tube may be recommended for certain studies
    • Sysmex Inostics' specimen collection and shipping kits include Streck blood collection tubes
    • Plasma or purified cfDNA from samples collected in Streck or EDTA tubes is acceptable
    • ~5x106
    • ~10 mL plasma required for cfDNA analysis
    Turnaround
    time
    7 – 10 Business days
    Performance

    Plasma-Safe-SeqS can detect between 5-7 mutant molecules (95% CI) irrespective of the amount of wildtype DNA present and/or the panel configuration. For 33 ng DNA input, this corresponds to 0.05-0.07% mutant allele frequency (MAF).