SafeSEQ Panel

Head and Neck Squamous Cell Cancer

The SafeSEQ HNSCC Cancer Panel is an ultra-sensitive liquid biopsy solution for the identification of gene mutations in CDKN2A, EGFR, ERBB2, FGFR3, HRAS, KRAS, NOTCH1, PIK3CA, PTEN, and TP53 for emerging Head and Neck Squamous Cell Cancer (HNSCC) clinical applications. (See table below).

The SafeSEQ HNSCC Cancer Panel is a clinical grade, ultra-sensitive liquid biopsy solution for the identification of gene mutations in CDKN2A, EGFR, ERBB2, FGFR3, HRAS, KRAS, NOTCH1, PIK3CA, PTEN, and TP53 for emerging Head and Neck Squamous Cell Cancer (HNSCC) clinical applications. The table shows genes, gene regions covered (amino acids), and clinical relevance.

The SafeSEQ Head and Neck Cancer Panel has been designed for human papillomavirus (HPV)-negative patients (~75% of HNSCC patients) and can be used to detect novel therapeutic targets and frequently occurring driver mutations for treatment response monitoring.

The SafeSEQ Panel delivers high-sensitivity mutation detection in HNSCC with a limit of detection of 0.05% MAF. Reliable detection of low-frequency mutations directly impacts the cost of clinical development. For example, to enroll 50 patients into a clinical study based on HRAS mutation status, many more patients must be tested if the assay cannot reliably detect mutations below 1% MAF, which increases both time and cost.

Clinical Relevance

The first targeted therapy for HNSCC to exploit the epidermal growth factor receptor (EGFR) was approved in 2006,1 and recently two immunotherapies have been adopted into clinical practice.2,3 However, molecular testing is not routinely performed in HNSCC except for the presence of tumor- expressed HPV, which represents a distinct subtype with a generally favorable prognosis. Recent advances in comprehensive genomic characterization of HNSCC have revealed numerous molecular alterations that are actively being pursued as therapeutic targets.4

Activating mutations in HRAS and PIK3CA have been characterized for HPV-negative HNSCC and may be indications for novel precision therapies. Circulating tumor DNA (ctDNA) is an attractive option for mutation detection in HNSCC via a minimally invasive blood draw to capture the mutational profile across a patient’s tumor burden because tissue biopsy specimens are not readily available for patients considering later line therapies.

The Sysmex Inostics SafeSEQ HNSCC Panel is a focused, ultra-high sensitivity solution that prioritizes depth and quality of information over breadth of genomic coverage, making it ideal for cost-effective clinical development for targeted therapies. This purpose-designed panel can also be used for high-sensitivity molecular monitoring to help gauge patients’ response to different therapeutic modalities, with the potential to exceed the resolution offered by current imaging techniques.

References

  1. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Erbitux BLA 125084/SUPPL-46 supplement.  March 1, 2006. Accessed  October 9, 2018. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125084s046LTR.pdf
  2. FDA Approves Pembrolizumab for Head and Neck Cancer.  August 24, 2016. Accessed  October 9, 2018. https://www.cancer.gov/news-events/cancer-currents-blog/2016/fda-pembrolizumab-hnscc.
  3. FDA Approved Nivolumab for Head and Neck Cancer.  December 1, 2016. Accessed October 9, 2018. https://www.cancer.gov/news-events/cancer-currents-blog/2016/fda-nivolumab-scchn
  4. Ferlay J, Shin HR, Bray F, Forman D, et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010;127(12):2893-917. doi: 10.1002/ijc.25516.

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