TEST:

SafeSEQ HPV Test

This ultra-sensitive HPV profiling method with optimal analytical performance may represent a significant advancement in risk stratification, treatment management, and post-treatment surveillance for patients with OPSCC.

Rapid early clearance of ctHPV-DNA during neoadjuvant therapy demonstrates utility in predicting response to treatment. Detectable ctHPV-DNA following treatment is predictive of both disease recurrence and worse survival.

"Sysmex Inostics...is proud to announce its participation at the AACR Special Conference in Cancer Research: Liquid Biopsy: From Discovery to Clinical Implementation, taking place on November 13-16, 2024 (San Diego, CA). Sysmex Inostics will be presenting two groundbreaking posters emphasizing clinical utility of HPV-SEQ, our commercially available next-generation sequencing (NGS) assay performed in a CLIA validated lab. The HPV-SEQ assay detects cell-free HPV DNA, enabling monitoring of treatment response and surveillance in HPV-related oropharyngeal cancer."

"Sysmex Inostics Inc...in collaboration with the University of Chicago Medicine announces the publication of results from the OPTIMAII trial in JAMA Oncology. Circulating tumor HPV-DNA (ctHPV-DNA) clearance, monitored using HPV-SEQ assay, predicts improved survival in patients with HPV-associated oropharyngeal cancer following nivolumab-based neoadjuvant therapy."

No abstracts available

The RaDaR assay but not CAPP-seq may detect MRD in patients who relapse within 1 year. HPV-seq may be more sensitive than dPCR for MRD detection.

Whole viral genome sequencing genotypes and quantifies plasma HPV DNA. Pts with residual HPV DNA had poorer RFS and OS, independent of stage. For HPV16, HPV-seq and dPCR are strongly correlated, but HPV-seq is more sensitive with higher negative predictive value and predicted 2.3x more 3-year recurrences in OPC pts.

The level of HPV16 ctDNA but not HPV16 E6 antibodies in plasma was associated with disease burden. These findings have potential implications for early detection and prognostication.

Persistent HPV ctDNA after CRT is independently associated with inferior PFS. HPV ctDNA testing can identify, as early as at the end of CRT, patients at high risk of recurrence for future treatment intensification trials.