OncoMark

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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.

2015

Relevant peer-reviewed publication: 

- Lanigan F et al. Delineating transcriptional networks of prognostic gene signatures refines treatment recommendations for lymph node-negative breast cancer patients. FEBS J 2015; 282:3455-73.

Key points from the Lanigan et al. discovery study:

• ARACNe: Bioinformatic method that constructs gene regulation networks.
• “Which genes regulate the prognostic genes in three existing prognostic signatures for breast cancer?” 
• A panel of ten ‘Master Transcriptional Regulators’ (MTRs) was identified.
• A basic risk score was constructed from a subset of the MTRs shown to be prognostic for breast cancer survival (mRNA and protein level).

2016

Development of OncoMasTR at OncoMark

Key conclusions from the product development work:

• Using a clinical specimen cohort with long term outcomes (‘Consecutive Cohort’, n=225, 37 distant recurrence events), a 3-gene signature, including the FOXM1, PTTG1, and ZN367 genes (FPZ, hereafter), was development and optimized.    
• From this 3-gene signature, three FPZ-based risk scores were derived:

              i.    A molecular only numeric risk score (0-100)
             ii.    A molecular and clinical numeric risk score (0-10)
            iii.    A molecular and clinical categorical risk score (low if risk <5, high if risk ≥5)

2017

Relevant peer-reviewed publication: 

- Moran B et al. Master Transcriptional Regulators in Cancer: Discovery via Reverse Engineering Approaches 

- 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.

2018

The OncoMasTR assay was CE-marked under the CE-IVD directive.  

Three independent external clinical validation studies were initiated, using pre-specified risk scores for the OncoMasTR assay:  

1. TransATAC (n=646)
2. TAILORx (n=404), Irish subset of broader TAILORx trial.
3. ABCSG-8 (n=1,087)

Together, these studies included FFPE specimens from over 2000 women with ER-positive, HER2-negative early stage breast cancer (Lymph node negative or 1-3 nodes Lymph nodes positive)

Key conclusions from the clinical validation studies:

• OncoMasTR was significantly prognostic for distant recurrence (DR) in all three studies.
• In two of the studies (TransATAC and the TAILORx (Irish) subset) where data was available to support comparative analyses, OncoMasTR provided superior prognostic value to Oncotype DX^TM Recurrence Score (RS).

Cepheid and OncoMark begin collaboration discussions to develop a GeneXpert version of the OncoMasTR assay.

2019

OncoMark initiated real-world, decentralized evaluations of the OncoMasTR assay at three sites:  

1. St James’ Hospital, Ireland
2. Beaumont Hospital, Ireland
3. Utrecht Medical Centre, The Netherlands
4. Lund University, Sweden

Key conclusions from the beta-site testing and analytical validation (Analytical Validation of OncoMasTR according to CLSI Guidelines):

• OncoMasTR displays robust analytical performance and is potentially suitable for decentralized use. 
• Overall precision of OncoMasTR was high, with a standard deviation of 0.16 (<2% of the 10-unit risk score range)
• OncoMasTR scores were consistent across a >100-fold RNA input range
  • Across 4 testing sites, the continuous OncoMasTR risk score correlation coefficients were 0.94 – 0.96 and the categorical score concordance was 86 – 96%.

Cepheid and OncoMark enter into a formal collaboration to develop a GeneXpert version of the OncoMasTR assay. 

2020

Relevant peer reviewed publication: 

- Buus R et al. Validation of the OncoMasTR risk score in estrogen receptor-positive/HER2-negative patients:  
A TransATAC study. Clin Can Res. 2020; 26:623-31.

- Mazo C et al. Multi-gene prognostic signatures and prediction of pathological sponse to neoadjuvant chemotherapy in ER-positive, HER2-negative breast cancer patients. Cancers 2020; 12(5):1133.

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.

2021

Relevant peer reviewed publication:

- Lynch SM et al. Prognostic value of the 6-gene OncoMasTR assay in hormone receptor-positive HER2-negative early-stage breast cancer: Comparative analysis with   standard clinicopathological factors. Eu J Can. 2021; 152:  78-79.

- Filipits F et al. The OncoMasTR assay predicts distant recurrence in estrogen     receptor-positive, HER2-negative early stage breast cancer:  A validation study in ABCSG Trial 8. Clin Cancer Res. 2021 Nov 1;27(21):5931-5938. 

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.

2022

Relevant peer-reviewed publication:

- Loughman T et al. Analytical Validation of the OncoMasTR Assay, a Novel Multigene Signature for Prediction 
of Distant Recurrence in Estrogen Receptor-Positive, HER2-Negative, Early-Stage Breast Cancer. Clin Chemistry. 2022; 68:6. https://doi.org/10.1093/clinchem/hvac028