SpaceGen's ctHPV MRD Shining ASCO 2026: A Prospective Investigation into the Application of Circulating Tumor HPV DNA in Cervical Carcinoma

At the recently concluded 2026 annual meeting of the American Society of Clinical Oncology (ASCO), the clinical research on ctHPV in the oncology domain garnered significant attention, and a dedicated session was organized for its discussion. An abstract from China has attracted high international attention in the field of gynecological oncology. SpaceGen, together with the team OF Professor Zhou Ying of THE FIRST AFFILIATED HOSPITAL OF USTC(ANHUI PROVINCIAL HOSPITAL). The study (Abstract 538356) on cervical cancer proactively employed ultra - sensitive droplet digital polymerase chain reaction (ddPCR) and next - generation sequencing (NGS) technology to detect cell - free human papillomavirus DNA (ctHPV - DNA) in peripheral blood (research registration number: NCT06456112). The surveillance of minimal residual disease (MRD) and the early evaluation of pelvic/abdominal para - aortic lymph node metastasis have paved a novel non-invasive avenue, which has effectively facilitated the clinical implementation of liquid biopsy for gynecological tumors. This project is an industry - university - research initiative (2024AH040260) sponsored by the Anhui Provincial Department of Education.

Clinical Background

Cervical cancer ranks as the fourth most prevalent malignant tumor in terms of morbidity and mortality among women globally. In 2022, approximately 660,000 new cases and 350,000 deaths were reported, with 90% of the affected women residing in low - or middle - income countries. According to the statistics from the National Cancer Center, in 2022, there were 150,000 new cases of cervical cancer and 55,000 deaths in China. The number of cases and deaths surpasses the combined figures of other gynecological tumors.

The most crucial prognostic factors for cervical cancer are the disease stage and the presence or absence of lymph node metastasis. Tumor size also serves as an independent prognostic factor. Early - stage diseases (≤IB2 stage) are typically treated through surgical intervention, with a recurrence risk of 8% to 10% within 2 years. Advanced - stage diseases are managed with radiotherapy and chemotherapy, and the recurrence risk within 2 years ranges from 30% to 50%.

For women who have undergone treatment for invasive cervical cancer, routine clinical examinations are conducted regularly, and auxiliary imaging examinations, such as magnetic resonance imaging (MRI) or computer tomography (CT), are performed when necessary. However, at present, there is no reliable monitoring marker to predict which patients are more prone to relapse after cervical cancer treatment.

The capacity to predict the presence of residual/refractory diseases within 15 months prior to the diagnosis of recurrence holds significant clinical value. It can be utilized to confirm the possibility of residual pelvic diseases after radiotherapy and chemotherapy, thereby enabling the proposal of life - saving surgeries to patients. Early detection of refractory/recurrent diseases can narrow the surgical scope. In cases where recurrence invades neighboring organs, surgical removal is necessary to ensure complete eradication.

Technical Difficulties

The overwhelming majority of cervical cancer cases are attributable to persistent infection with high - risk human papillomavirus (hrHPV). The E6 and E7 genes of this virus have the potential to integrate with the host DNA. HrHPV typically encompasses 14 types, among which the combined proportion of types 16 and 18 exceeds 70%. Circulating tumor DNA (ctDNA) refers to a fragment of the tumor genome that is released into the circulatory system by tumor tissues, cells, etc. HPV integrated into the host genome is also released in the form of ctDNA. Multiple guidelines have reached a consensus in recommending ctDNA for the evaluation of molecular residual lesions (MRD). ctHPV is not affected by the wild - type background in the total free DNA. It is easier to detect and identify compared to point mutations, yet its abundance is extremely low. The short fragments of ctHPV - DNA impose stringent requirements on detection technology.

SpaceGen furnished self - developed ultra - sensitive digital droplet polymerase chain reaction (ddPCR) detection and next - generation sequencing (NGS) detection solutions for this study to conduct a “dual - platform back - to - back” analysis of each blood sample.

Research Highlights and Results Report

This study initially planned a prospective enrollment of patients with HPV16/18-positive cervical cancer, with a total of 83 cases scheduled for inclusion in the group. At the time of reporting, data analysis of 76 patients had been completed. Ultra-sensitive ddPCR and NGS technologies were employed to quantitatively detect the circulating tumor human papillomavirus (ctHPV) load in patients. The consistency of the two detection methods was evaluated through correlation analysis and the Bland - Altman diagram. The correlation between the ctHPV expression level and lymph node metastasis (LNM) status, as well as its variation with the size of the primary tumor, was analyzed. Currently, dynamic testing of ctHPV after treatment is still in progress, and long - term follow - up of patients is being conducted to explore the potential association between the changing trend of ctHPV and the efficacy and prognosis.

The results of this report indicate that circulating tumor human papillomavirus (ctHPV) can be detected in all patients at the time of initial diagnosis. The test results of ultra - sensitive ddPCR and NGS exhibit good agreement. The Bland - Altman analysis reveals that the bias between the two methods is extremely small, confirming that ddPCR can serve as a rapid and clinically applicable quantitative detection method. The initial ctHPV load of patients with lymph node metastasis (LNM) was significantly higher than that of patients without metastasis, and the ctHPV level increased with the increase in the primary tumor volume. The above results suggest that ctHPV can be utilized to reflect the tumor load and lymph node metastasis status of patients at the time of initial diagnosis.

Clinical Transformation: Enabling Cutting - edge Technology to Benefit a Broader Patient Population

The findings of this report indicate a correlation between the ctHPV level at the initial diagnosis of cervical cancer patients and the size of the primary tumor as well as lymph node metastasis. ddPCR is a rapid and reliable technique for detecting ctHPV. Subsequently, Professor Zhou Ying's research team will conduct a longitudinal follow - up analysis to explore the dynamic changes of ctHPV during treatment and follow - up, and assess its value as a minimal residual disease (MRD) and prognostic marker. It is anticipated to provide a novel reference basis for the comprehensive clinical management of cervical cancer patients. This signifies that the liquid biopsy of cervical cancer centered on ctHPV - DNA is transitioning from scientific research evidence to the "last mile" of routine clinical application. Non - invasive, real - time, and quantitative MRD monitoring is expected to bring about a revolutionary change in the postoperative follow - up model of cervical cancer. In the future, patients may only require regular blood sampling to detect the recurrence risk at an early stage, avoid excessive imaging examinations and anxious waiting, and achieve true pre - treatment risk stratification and pre - treatment intervention.

Reference

J Clin Oncol 44, 2026 (suppl 16; abstr e17511)