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FOR CLINICAL DEVELOPMENT AND PATIENT MANAGEMENT

HPV-SEQ
NGS Panel

Ultra-sensitive liquid biopsy solution for the detection and quantification of circulating HPV 16 and HPV 18 DNA

Sysmex Inostics cfHPV and somatic mutation detection solutions represent a promising step forward for clinical development of novel therapeutic and patient management approaches for HPV-related cancers.

HPV-SEQ is CLIA-validated and available to support clinical trials through the Sysmex Inostics turnkey testing service in its CLIA lab located in Baltimore, MD.

Download Now: University of Chicago poster demonstrating real-world application of HPV-SEQ:

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  • HPV-SEQ is a clinical grade, ultra-sensitive liquid biopsy solution for the detection and accurate quantification of circulating HPV 16 and HPV 18 DNA in patients with cancers caused by HPV infection.
  • Applying a unique, proprietary ultra-sensitive Plasma-Safe-SeqS technology to identify and quantify circulating HPV DNA may better detect clinically meaningful changes.

Clinical Revelance

  • Demonstrates high analytical sensitivity, with the ability to reliably and consistently detect few HPV 16 or HPV 18 DNA copies present.
  • Exhibits quantitative detection of HPV across a broad dynamic range, enabling high-resolution molecular monitoring for superior correlation with therapeutic benefit.

  • Displays low quantitative variability (<30% CV above 5 copies).

  • Demonstrates low level of background signal (<0.04 copies per sample across 20 healthy donor samples), indicating high specificity.

Treatment response

HPV-SEQ has been employed to evaluate dynamic changes in circulating HPV alongside patients’ radiographic assessment of therapy response to assess future utility in guiding treatment de-escalation strategies.

Disease surveillance and beyond

Demonstrating ultra-sensitive detection of cfHPV-DNA, HPV-SEQ may be used during and at conclusion of cancer treatment to assess the diminishing presence or total absence of cfHPV-DNA as a surrogate of disease burden.

Dynamic changes in patients’ cfHPV-DNA levels in response to induction therapy1

References
  1. Sloan, H. et al. (2021) Ultra-sensitive detection and quantification of HPV DNA in the plasma of patients with oropharyngeal squamous cell carcinoma (OPSCC) enrolled in the OPTIMA 2 treatment de-escalation trial. Journal of Clin Oncol. 39:15_suppl, 6048-6048.