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Ultra-sensitive liquid biopsy solution for the identification of gene mutations in CDKN2A, EGFR, ERBB2, FGFR3, HRAS, KRAS, NOTCH1, PIK3CA, PTEN, and TP53

HNSCC-SEQ detects mutational drivers of head and neck squamous cell carcinoma (HNSCC). With high specificity, Plasma-Safe-SeqS technology is optimized to detect low-frequency mutant molecules, with a limit of detection of 0.04% MAF, in plasma for potential uses:

  • Aid in cancer drug development
  • Monitor therapeutic efficacy
  • Identify treatment resistance
  • Detect minimal residual disease (MRD)

To download current on-going clinical trial designs for HPV(+) & HPV(-) HNSCCs:


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  • Quickly and accurately identify patients appropriate for treatment.
  • Detect residual disease and assess response to therapy (including immunotherapy) using non-invasive, rapid, and real-time ctDNA assay.
  • Avoid over-treatment in the neoadjuvant and adjuvant settings.
  • Allow for individualized decisions to optimally refine treatment regimens.
  • Serve as useful intermediate endpoints and improve efficiency of clinical trials.

Clinical Revelance

The epidermal growth factor receptor (EGFR) is an established therapeutic target in HNSCC. The first targeted therapy for HNSCC to exploit EGFR was approved in 2006,1 and recently two immunotherapies have been incorporated into clinical practice.2,3 However, molecular testing is not routinely performed in HNSCC evaluation, 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 personalized therapies.

Analyzing circulating tumor DNA (ctDNA) is an attractive option to detect HNSCC-specific mutations via a minimally invasive blood draw. This would be a preferred method to determine the mutational profile of a patient’s tumor since tissue biopsy specimens are not readily available for patients considering later line therapies.

Enabling discoveries in biopharma

HNSCC-SEQ has been designed for human papillomavirus (HPV)-negative patients and can be used to detect novel therapeutic targets and frequently occurring driver mutations for treatment response monitoring. HNSCC-SEQ delivers high-sensitivity mutation detection in HNSCC with a limit of detection of 0.04% MAF.

Panel features

CDKN2A 51-61, 90-91, 96-124, 143-152 Putative therapeutic indication
Marker of poor prognosis
EGFR 283-296, 464-487, 706-725, 856-873 Therapeutic indication
ERBB2 305-315
FGFR3 242-269, 370-392 Putative therapeutic indication
HRAS 9-27, 55-67, 105-118, 144-150 Putative therapeutic indication
Marker of poor prognosis
KRAS 5-26, 141-148, 156-174 Predictive marker for anti-EGFR therapy
Putative therapeutic indication
NOTCH1 184-209, 290-315, 440-468, 562-582, 1836-1862, 1979-1997 Putative therapeutic indication
PIK3CA 72-93, 108-117, 330-352, 354-371, 418-421, 440-462, 538-553, 597-614, 714-728, 970-978, 1001-1025, 1040-1056 Putative therapeutic indication
PTEN 6-26, 87-104, 117-136, 229-247, 335-342 Putative therapeutic indication
TP53 26,32, 49-77, 99-125, 126-141, 151-17, 192-219, 233-260, 262-285, 297-306, 308-331, 332-360, 368-383 Truncal mutations important for monitoring
  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.
  2. FDA Approves Pembrolizumab for Head and Neck Cancer.  August 24, 2016. Accessed  October 9, 2018.
  3. FDA Approves Pembrolizumab for Head and Neck Cancer.  August 24, 2016. Accessed  October 9, 2018.
  4. Jiang X, Ye J, Dong Z, Hu S, Xiao M. Novel genetic alterations and their impact on target therapy response in head and neck squamous cell carcinoma. Cancer Manag Res. 2019;11:1321-1336. Published 2019 Feb 8. doi:10.2147/CMAR.S187780.