Cerca Biotech announced at the 2026 European Congress of Pathology (ECP) that the MammaTyper® Low-Risk Prediction (LRP) model identified HR+/HER2− breast cancer patients with an Oncotype DX® Recurrence Score (RS) of ≤25 at a positive predictive value of 95% — supporting its use as a locally available, low-cost molecular pre-screen before multigene testing.
Study at a glance
| Item | Detail |
|---|---|
| Design | Multicenter, retrospective |
| Investigators | Vall d’Hebron University Hospital; Virgen de la Victoria University Hospital; Malaga Biomedical Research Institute (Spain) |
| Samples | 211 archived HR+/HER2− breast cancer tissue samples with prior Oncotype DX® RS results |
| Model inputs | ESR1, PGR and MKI67 mRNA expression by RT-qPCR |
| Endpoint | Identification of patients classified low recurrence risk by Oncotype DX® (RS ≤25) |
| Key result | 95% positive predictive value |
What the SCORE study found
The multicenter, retrospective SCORE study evaluated 211 archived breast cancer tissue samples from patients who already had Oncotype DX® Recurrence Score results. MammaTyper® LRP, calculated from ESR1, PGR and MKI67 mRNA expression, identified — with a positive predictive value of 95% — patients classified as low recurrence risk by Oncotype DX® (RS ≤25), a group unlikely to benefit from chemotherapy.
The findings were presented by investigators at the 2026 European Congress of Pathology, positioning MammaTyper® LRP as a cost-effective, locally available testing tool for HR+/HER2− breast cancer.
Corroborating evidence
The SCORE results confirm earlier findings and align with recent independent work:
- A previously presented German multicenter study (H-A Lehr, et al., 2019) on standardized prediction of Oncotype DX® risk classes by local RT-qPCR.
- A recently published Chinese retrospective study (Ding M, et al., 2026) showing the MammaTyper® LRP score is an independent prognostic factor in early-stage HR+/HER2− breast cancer, and that patients classified as LRP low risk derived no benefit from adjuvant chemotherapy.
Why this matters
Multigene assays such as Oncotype DX® are not universally accessible or reimbursed. A quantitative RT-qPCR pre-screen that can be run on existing local laboratory infrastructure offers a practical pathway to rule in low-risk patients first, reserving more expensive multigene testing for those who need it — a chemotherapy de-escalation logic that matters most in cost-constrained health systems.
“These findings support the potential of MammaTyper® LRP as a locally available low cost molecular pre-screen for identifying patients having an Oncotype DX® RS ≤25 who are at low recurrence risk. We are encouraged by the results of the SCORE study and by the potential of MammaTyper® to become a widely accessible, cost effective, and versatile molecular tool for improving personalized precision treatment of breast cancer.”
— Rich Hughes, Commercial Director, Cerca Biotech
About MammaTyper®
MammaTyper® is an assay for the quantitative determination of the four key biomarkers used in breast cancer subtyping — HER2, estrogen receptor (ER), progesterone receptor (PR) and Ki-67. Using sensitive and quantitative RT-qPCR, it provides a quick, accurate, reliable and reproducible result that helps clinicians tailor treatment plans. Further information is available at cercabiotech.com/product/mammatyper.
About Cerca Biotech
Cerca Biotech is a Germany-based diagnostic company bringing novel diagnostic products to the oncology and women’s health market, with commercial reach from Germany through the Nordics and Eastern Europe to the Middle East, Africa and India. More information: www.cercabiotech.com or info@cercabiotech.com.
References
- Correlation of RT-qPCR–based progesterone receptor, estrogen receptor, and Ki-67 expression with multigene recurrence risk in hormone receptor–positive/HER2-negative breast cancer (SCORE study). ECP 2026.
- H-A Lehr, et al. Standardized prediction of Oncotype DX® risk classes by local RT-qPCR. Cancer Res. 2019;79(4_Supplement):P2-07-08. doi:10.1158/1538-7445.SABCS18-P2-07-08
- Ding M, et al. Clinical validation of the MammaTyper® LRP model for identification of low risk patients with early-stage ER+/HER2− breast cancer: from subtyping to chemotherapy de-escalation. Clinical Breast Cancer. Available online 24 August 2026.
- MammaTyper® is a trademark of Shuwen Biotech. Oncotype DX® is a trademark of Exact Sciences Inc.
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Source: SCORE Study Results of MammaTyper® LRP Model in HR+/HER2− Breast Cancer Presented at ECP 2026, EINPresswire, 17 September 2026
Edited by Shuwen Biotech. For professional discussion only.
