Independent Validation of Apo10 and TKTL1 Biomarkers Strengthens PanTum Detect’s Scientific Foundation
A recently published study in BMC Medicine provides strong, independent evidence supporting the clinical utility of the EDIM-based biomarkers Apo10 and TKTL1 for the early detection of cervical cancer. These are the same two biomarkers at the heart of RMDM’s PanTum Detect test.
In this study conducted at Sun Yat-sen University Cancer Centre, 152 patients with cervical cancer and 152 matched healthy controls were enrolled between November 2020 and August 2023. Blood macrophages were analysed using the Epitope Detection in Monocytes/Macrophages (EDIM) approach to measure:
• Apo10, a marker of dysregulated apoptosis and impaired DNA repair
• TKTL1, a marker of metabolic reprogramming (aerobic glycolysis) in malignant cells
Individually, both biomarkers showed strong diagnostic performance( 86,5%) and when combined (APT), diagnostic accuracy rose to 90% outperforming conventional tumour markers such as CEA (69%), CA125 (59,4%), and SCC-A (80%).
While HPV testing and cytology (TCT) have been mainstays of cervical cancer screening for decades, both have limits in detection. HPV testing cannot detect the small but clinically important group of HPV-negative cervical cancers, and cytology is vulnerable to sampling errors, lesion heterogeneity, and subjective interpretation.
The new study is especially significant for HPV-negative disease, a group of 3–8% of all cervical cancers. These cancers often bypass viral pathways and instead rely on metabolic reprogramming and hypoxia-driven signalling.
TKTL1, which detects this metabolic switch, can identify both HPV-positive and HPV-negative cancers, effectively closing the diagnostic gap left by HPV testing.
Performance remained high in groups where standard methods underperform:
• HPV-negative cases – 95%
• TCT-negative cases – 95%
Unlike cytology, which depends heavily on sample quality, anatomical access, and expert interpretation, the EDIM Apo10/TKTL1 assay requires only 2.7 mL of blood. Uses stable samples at room temperature. Relies on standardised flow cytometry rather than subjective microscopic analysis.
These features make PanTum Detect particularly suitable for primary care and low-resource settings, helping to democratise access to high-quality cancer screening.
Although this study focused on cervical cancer, Apo10 and TKTL1 identify fundamental cancer hallmarks, defective apoptosis and altered metabolism, which are common across many solid tumours. Large-scale PanTum Detect data show its utility as a pan-tumour screening method.
In advanced healthcare systems, PanTum Detect can serve as a reflex test in HPV-negative or cytologically indeterminate cases. In resource-limited environments, it could be deployed as a primary screening tool, reducing dependence on specialised infrastructure.
The convergence of this independent academic study, establishes PanTum Detect’s performance for 3 different reasons :
1. Independent validation – Apo10 and TKTL1 have been confirmed as clinically relevant in cervical cancer by an external research group.
2. Cross-tumour potential – The same biomarkers detect a wide range of other solid tumours, supporting their broader use in screening strategies.
3. Targeted deployment – Integrating the APT score into PanTum Detect reporting could strengthen its role in women’s health, especially for patients with negative HPV or cytology results.
RMDM remains committed to advancing biomarker-driven solutions that enable earlier detection, improve risk stratification, and ultimately contribute to better patient outcomes. The alignment of independent academic evidence with PanTum Detect’s existing clinical performance data strengthens the case for broad implementation testing and targeted screening initiatives.
References:
1. Chen Y, Liang Z, Zhang L, et al. Apo10 and TKTL1 in blood macrophages as non-invasive biomarkers for early detection of cervical cancer. BMC Medicine. 2025;23:41. doi:10.1186/s12916-025-04038-9 ↩
2. Zyagnum AG. New study shows PanTum Detect test makes early cancer diagnosis possible for nationwide screening. 2022. Available from: https://www.zyagnum.com/en/study-may-20th-2022/ ↩