Loading
Pi3k/akt/mtor Signaling in Cancer / Chemokine Receptors and Signaling · Journal article
Diagnostic Pathology · August 18, 2026
Reinforces what was already believed, rather than introducing something new.
This single-center retrospective study demonstrates excellent concordance (99.3%) and strong inter-observer reproducibility (κ=0.93–0.96) between SP218 and MXR060 antibodies for PTEN protein detection in HR+/HER2− breast cancer. The findings support the technical interchangeability of these two antibodies in routine clinical practice, though generalizability to other laboratories and populations remains unestablished.
Single-center retrospective concordance study. 150 hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) breast cancer specimens from a single center in mainland China.. Intervention: Immunohistochemical staining with SP218 antibody (Roche/Ventana).. Compared with: Immunohistochemical staining with MXR060 antibody (Maixin Biotech).. n = 150. Single center in mainland China..
Overall concordance rate 99.3% (149/150) between SP218 and MXR060 antibodies with Cohen's kappa 0.98 PTEN loss rates 23.3% (SP218) and 22.7% (MXR060) in 150 HR+/HER2− breast cancer samples Positive concordance rate 97.1% and negative concordance rate 100%
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Pathologists selecting between SP218 and MXR060 antibodies for routine PTEN IHC testing in HR+/HER2− breast cancer can use either interchangeably with confidence. This study does not establish new clinical indications for PTEN testing but validates technical equivalence of two available platforms.
Well-designed single-center concordance study with clear methodology and strong statistical agreement (κ=0.98) that validates interchangeability of two antibodies in routine practice, but does not establish new clinical utility or change diagnostic approach.
As stated by the source record.
Quoted from the source exactly as published.
Pathologists selecting between SP218 and MXR060 antibodies for routine PTEN IHC testing in HR+/HER2− breast cancer can use either interchangeably with confidence. This study does not establish new clinical indications for PTEN testing but validates technical equivalence of two available platforms.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
PTEN protein expression is an increasingly important biomarker in breast cancer, especially for predicting the efficacy of PI3K/AKT/mTOR pathway-targeted therapy. Immunohistochemistry (IHC) is a commonly used method in clinicopathology to assess PTEN protein expression; however, the concordance of different antibodies in detecting PTEN protein expression in breast cancer has not been systematically evaluated. This study aims to compare the concordance of two commonly used PTEN IHC antibodies in clinical practice in mainland China. This single-center retrospective study included 150 hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) breast cancer specimens. Immunohistochemical staining was performed using SP218 antibody (Roche/Ventana) and MXR060 antibody (Maixin Biotech) on their respective automated platforms. PTEN protein expression was categorized into loss and retained. Two senior pathologists independently reviewed the slides; cases with differing opinions were adjudicated by a third pathologist. Next-generation sequencing (NGS) was performed on cases with inconsistent antibody results to analyze PTEN gene status. Cohen’s kappa statistics were used to assess concordance between antibodies and between observers. In 150 samples, the loss rates of PTEN protein in breast cancer detected by SP218 antibody and MXR060 antibody were 23.3% and 22.7%, respectively. The overall concordance rate of the two antibody detections reached 99.3% (149/150), with a positive concordance rate of 97.1% and a negative concordance rate of 100%, and a Kappa value of 0.98, indicating excellent concordance. The inter-observer concordance Kappa values for the SP218 and MXR060 antibodies were 0.93 and 0.96, respectively. After review by a third physician, only one case showed inconsistent interpretation; NGS testing showed no mutation in the PTEN gene. The MXR060 and SP218 antibodies demonstrated excellent concordance and considerable inter-observer reproducibility in PTEN IHC assays for HR+/HER2− breast cancer. This provides evidence for the interchangeability of the two antibodies in clinical practice and offers a reference for pathology laboratories in selecting PTEN antibodies.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.