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ENABLING DISCOVERIES IN BIOPHARMA

BC-SEQ Panel

Reliable, ultra-sensitive detection of low-frequency plasma mutations in patients with breast cancer

Easily identify gene mutations in 27 regions across clinically relevant oncogenes and tumor suppressors, including PIK3CA, ESR1, AKT1, ERBB2, TP53, and KRAS to detect established and emerging therapeutic indications, resistance mutations, and frequently occurring somatic alterations with Sysmex Inostics BC-SEQ panel.

BC-SEQ is a clinical grade, ultra-sensitive liquid biopsy solution that can detect clinically relevant mutations in circulating tumor DNA (ctDNA) from patients with breast cancer across a broader range of genomic regions with an order of magnitude higher sensitivity compared to pan-cancer NGS tests while maintaining robust specificity. Greater sensitivity than other liquid biopsy NGS methods can accelerate trial enrollment and allow evaluation of biomarker hypotheses with greater power.

To learn how BC-SEQ can accelerate trial enrollment, download now:

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  • BC-SEQ panel features the most relevant targets for HR+ breast cancer yielding more information, with greater efficiency.
  • BC-SEQ panel detects gene mutations in PIK3CA, AKT1, and ESR1 with a limit of detection 0.04% mutant allele frequency (MAF).

Clinical Revelance

  • BC-SEQ panel detects gene mutations in PIK3CA, AKT1, and ESR1 with a limit of detection 0.04% mutant allele frequency (MAF).
  • Can identify a significant subset of patients for targeted therapy who may be missed by less sensitive technologies.
  • By accurately monitoring disease response and clonal dynamics, Plasma-Safe-SeqS enables the informed adaptation of therapeutic strategies.1

  • Detects prevalent driver mutations (e.g., PIK3CA and TP53) with exquisite sensitivity for minimal residual disease (MRD) detection and recurrence surveillance.2
  • Plasma-Safe-SeqS sensitivity has 99.2% agreement with OncoBeam™ digital PCR liquid biopsy breast cancer test.


Panel features

# OF ctDNA MOLECULES MUTANT ALLELE
FREQUENCY (MAF*)		 ANALYTICAL SENSITIVITY ANALYTICAL SPECIFICITY REPORTING
THRESHOLD
20 0.10% 100% 100% 6 ctDNA molecules (0.030% MAF)
10 0.050% 98%
5 0.025% 94%
3 0.015% 78%

*Based on cell-free DNA input of 66ng. Analytical sensitivity and specificity cited above is for targeted, clinically important regions. Reporting threshold is set above LoD95.

References
  1. Dawson SJ, Tsui DW, Murtaza M, Biggs H, et al. Analysis of Circulating Tumor DNA to Monitor Metastatic Breast Cancer. N Engl J Med. 2013;368:1199-209. doi:10.1056/NEJMoa1213261.
  2. Rodriguez BJ, Córdoba G, Aranda A, Álvarez M, et al. Detection of TP53 and PIK3CA Mutations in Circulating Tumor DNA Using Next-Generation Sequencing in the Screening Process for Early Breast Cancer Diagnosis. J Clin Med. 2019;8(8):1188. doi: 10.3390/jcm8081183.