Targeted Panel Assays:

Plasma-Safe-SeqS (PSS) Technology

BC-SEQ

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

HNSCC-SEQ

Reliable detection of clinically relevant mutations in HPV-negative HNSCC.

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.

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.

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Plasma-Safe-SeqS panel

Clinically relevant gene regions

Intended uses

RAS-RAF-SEQ

BRAF, KRAS, NRAS, AKT1, PIK3CA

  • Therapy selection
  • Therapeutic monitoring

HPV-SEQ

HPV 16, HPV 18

  • Therapy selection
  • Therapeutic monitoring
  • Recurrence surveillance

BC-SEQ

AKT1, ERBB2, ESR1, KRAS, PIK3CA, TP53

  • Therapy selection
  • Therapeutic monitoring
  • Recurrence surveillance

AML-MRD-SEQ & AML-SEQ

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 tubes is acceptable*
  • ~5x106
  • ~10 mL plasma required for cfDNA analysis

Turnaround time

7 – 10 Business days

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).

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).

*Inquire for additional acceptable sample collection types.