Xpert® Insight Breast Cancer[1] is a new test in development at Cepheid. This prototype multiplex, mRNA expression test is designed to measure the expression of six genes (3 biomarkers and 3 controls) in formalin-fixed, paraffin-embedded breast cancer tissue from patients with early stage breast cancer. The weighted expression of these genes will be combined with two clinical factors (tumor size and nodal status) using a proprietary algorithm to produce a binary risk score (high risk vs low risk) that is designed to predict the likelihood of distant disease recurrence in the next 10 years.
This test which was originally developed by Oncomark, an Ireland-based biotechnology company, and was initially named OncoMasTR™. Cepheid and OncoMark started collaborating in 2018 to explore development of a version of the OncoMasTR assay for use on the GeneXpert® system. This collaboration was successful, ultimately leading to the acquisition of OncoMark and the OncoMasTR technology by Cepheid in March 2021. Cepheid intends to market the test under the name Xpert Insight Breast Cancer.
The development of the OncoMasTR test began in 2014. Below, please find highlights of the major development milestones over the last seven years.
[1] Product in development. Not for use in diagnostic procedures. Not reviewed by any regulatory body.
Year
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Development Milestone(s)
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2014 |
Original invention relating to the OncoMasTR technology was jointly filed by the University College of Dublin and Trinity College Dublin with inventors Bracken, Lanigan and Gallagher.
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2015 |
Relevant peer reviewed publication: Key points from the Lanigan et al. discovery study:
|
2016 |
Development of OncoMasTR at OncoMark Key conclusions from the product development work:
i. A molecular only numeric risk score (0-100)
|
2017 |
Relevant peer reviewed publication: Training and verification of OncoMasTR assay was completed, with poster presentation of the data at the San Antonio Breast Cancer Symposium. In parallel, further development and validation studies were conducted according to CLSI guidelines (Analytical Validation of OncoMasTR according to CLSI Guidelines: Precision, Linearity, Sensitivity, RNA Input, Interference, Kit stability, manuscript under review).
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2018 |
CE mark was obtained for the OncoMasTR assay. Three, independent, external clinical validation studies were initiated, using pre-specified risk scores for the OncoMasTR assay:
Together, these studies included over 2,000 ER+, HER2-, early-stage (LN0-3) breast cancer patients. Key conclusions from the clinical validation studies:
Cepheid and OncoMark begin collaboration discussions to develop a GeneXpert version of the OncoMasTR assay.
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2019 |
OncoMark initiates real-world, decentralized evaluations of the OncoMasTR assay was initiated at three sites:
Key conclusions from the beta-site testing and analytical validation (Analytical Validation of OncoMasTR according to CLSI Guidelines):
Cepheid and OncoMark enter into a formal collaboration to develop a GeneXpert version of the OncoMasTR assay.
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2020 |
Relevant peer reviewed publication: Relevant peer reviewed publication: Cepheid assigns Xpert Insight Breast Cancer tradename to GeneXpert version of OncoMasTR assay. Cepheid demonstrates analytical equivalency of Xpert Insight Breast Cancer assay to OncoMasTR assay. Cepheid demonstrates the fidelity of risk score reporting between Xpert Insight Breast Cancer and OncoMasTR in characterized specimens.
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2021 |
Relevant peer reviewed publication: Relevant peer reviewed publication: Cepheid acquires OncoMark and the OncoMasTR assay. Cepheid demonstrates clinical equivalency of Xpert Insight Breast Cancer to OncoMasTR in FFPE specimens with long-term outcomes. Cepheid initiates real-world evidence and clinical validation studies for the Xpert Insight Breast Cancer prototype test. |
If you are interested in learning more, or engaging with Cepheid in a collaborative evaluation of the Xpert Insight Breast Cancer prototype test, please contact the Cepheid Medical and Scientific Affairs and Strategy team for Oncology at: MedSci.Oncology@Cepheid.com