University of Malta

Breast Cancer Detection
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Breast Cancer Detection

Methods for breast cancer detection with particular focus on HER-2 Positive and Triple Negative types.


HER-2 Positive Breast Cancer 
Project Number: KD01GGX

The Invention 

HER-2 is a gene involved in how breast cells grow, divide and repeat themselves. When the HER-2 gene is abnormal, breast cancers tend to grow faster, are more likely to spread and tend to recur (very aggressive). HER-2 positive breast cancers can be treated with specific medicines so detecting them accurately ensures the best treatment for the patient.


The test has the following advantages when compared to the state of the art: 

  • Elimination of ambiguous results - 100% certainty of detecting the biomarkers 
  • Minimal biopsy material needed (50ng)
  • Ability to analyse degraded material 
  • Faster processing time
  • Final test can be priced at same or lower price as current tests

Applications / Industries 

The test can be used to determine the presence of HER-2 Positive breast cancer. This may either replace or complement the current gold standard FISH test.

The technology can also be used to analyse archival patient material for research purposes. 

Development Status 

The test method was developed and has been tested on 700 patient samples, giving reproducible results with correlation (R2) values of 0.97-0.999 (fit with statistical model).



Triple Negative Breast Cancer 
Project Number: KD03GGX

The Invention 

Triple negative breast cancer (TNBC) patients have a poor prognosis. To date there are no markers that identify potential therapeutic groups within this subtype. With the use of our novel biomarkers we can classify patients into luminal and basal types and in addition, predict sensitivity to particular treatments.


The test has the following advantages when compared to the state of the art: 

  • Identifies a patient group which could be treated by a specific drug, particularly important for this group that currently has no targeted therapy 
  • Reduces costs related to testing kit as 4 biomarkers are required, when compared to the 10 currently in use for detection only
  • Can be used on archival material

Applications / Industries 

The test can be used to determine the presence of triple negative breast cancer and to stratify patients for treatment.

The test could be used as a companion diagnostic for a drug which is currently on the market but which is not used in the oncology sector. 

Development Status 

Both the biomarkers and the drug have been identified. Ten cell lines have already been studied and a further 20 cell lines will be added to the pool of data. Primary cells will be isolated from patients to measure the predictive power of the novel biomarkers and their sensitivity to a drug. This will also need to be followed up by clinical trials.



Intellectual Property Status 

Patent protection in the process of being sought for both inventions. The detection method also depends on a proprietary algorithm.

Commercial Interest

A spin-out company has been set up to commercialise these technologies - Biotech Innovations Ltd. (C76539). Biotech Innovations intends to carry out research to develop more kits and to offer testing services around its technologies.

We are looking for a manufacturing partner who would be interested in producing and distributing test kits to be used on the Luminex xmap platform.

We are also looking for pharmaceutical companies who are interested in developing companion diagnostic tools for particular drugs. 


Lead Originator 

Dr Godfrey Grech

Other Information

Supported through the TAKEOFF Seed Fund Award 2016

Supported through the Malta Council for Science & Technology's FUSION Programme 2016, project number R&I-2016-006-V

Dr Grech is coordinating the Molecular Therapeutics Group as part of the Molecular Diagnostics arm of Mater Dei Hospital, with the specific objectives:

  • to establish a definitive diagnosis based on unique molecular alterations in specific tumour types
  • to render prognostic information of clinical relevance, through the assessment of molecular predictors of outcome
  • to assist in the selection of personalised targeted treatment regimes, saving unnecessary drug toxicity and decreasing morbidity.


Download summary for HER-2 Positive Breast Cancer [PDF]

Download summary for Triple Negative Breast Cancer [PDF]


Interested? Contact Michelle Cortis or the Knowledge Transfer Office

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Last Updated: 6 July 2017

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