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Precision medicine test for the therapeutic decisions and monitoring of treatment response in breast cancer



Project Title: Precision medicine test for the therapeutic decisions and monitoring of treatment response in breast cancer

Funding: European Regional Development Fund (ERDF), Measure 1.2.1. Specific support goal "To Increase the Private Sector Investments R&D"; measure "Support for Improvement of Technology Transfer System" “Industry‑Driven Research”

Project Nr.: KC-PI-2017/23 

Project first period: 19 th July 2017 – 23 th July 2018

Project secound period: 1 October 2018 - 30 September 2021

Project costs: 333 333,33 EUR

Principle Investigator: Dr. biol. A. Linē

The main aim of the current project is to develop a precision medicine test for molecular profiling of breast cancer that helps to choose the best treatment option for each patient and a personalised liquid biopsy for monitoring the treatment response and early detection of recurrence.

The commercialisation strategy will contain a detailed plan for bringing the precision medicine tool described in this project to the market.

The commercialisation measures will consist of industrial research and experimental development aiming to demonstrate the clinical validity of the proposed precision medicine approach.         

The main objective of this project is to demonstrate the clinical validity of such a precision medicine approach in breast cancer patients. After the end of this project, these tests will be registered as laboratory developed tests and offered as molecular diagnostics services that can help in a clinical decision making.

This project will provide an opportunity to create a new in vitro diagnostics service that will be the first of its kind in Latvia and may turn out to be internationally competitive.

Published 24.07.2017.



In the period from 19.07.2017.until 19.10.2017. Within the framework of the project, a market research was conducted on potential bidders for the procurement of development of a commercialization strategy.

The procurement regulations for procurement "Development of a commercial strategy" were prepared. The purpose of the service is to define the steps to develop a product or technology from conception to market introduction, and also to analyze the choice of a more advantageous solution between assigning the right to use industrial property to another person (licensing agreement, patent sale) or creating a new business on a scientific basis, and make recommendation what information should be prepared to get potential licensees or investment funds attention and offer them the technology. The above-mentioned procurement was announced on the website of the Procurement Monitoring Bureau on 12.10.2017.

Published 19.10.2017.



The procurement resulted in concluding a contract with “Enixus Baltija” for the development of Commercialisation Strategy. Several meetings between the contractor and BMC team were organised to discuss the technological aspects, potential markets, IPRs, choice of commercialisation strategy and the next steps to the market. The contractor, in a close collaboration with the BMC team, is working on the development of the Commercialisation Strategy. In parallel, we were working on the development of the technical-economic feasibility study.

Published 31.01.2018.



In reporting period was agreed project 1st period extension whit Latvian Investment and Development Agency to ensure quality of a Technical feasibility and commercialisation strategy development.  Was prepared procurement rules for “Technical feasibility and commercialisation strategy development service” as part of which is planned to purchase individual previously undrafted Technical feasibility study section as well as Commercialisation strategies for project. The above procurement was announced in Procurement Monitoring Bureau web page in 20.03.2018.

The offer was submitted and as the winner in the procurement was recognized KPMG Baltics Ltd

 Published 18.04.2018.



During the reporting period continue work to the development of the Technically Economic feasibility study and the Commercialisation strategy with “KPMG Baltics”.

Published 18.07.2018.


1 October 2018 – 31 December 2018

LIAA has completed the evaluation of the Commercialisation strategy and Technical and economic feasibility study and took the decision to continue funding of this project on 28.09.2018. Implementation of the second stage of the project was started on 01.10.2018. We have accomplished the following tasks during this reporting period:

-       We have developed a protocol for the enrolment of breast cancer patients and collection of the clinical samples and prepared the application to CMĒK and GIP to obtain the permission to carry out the study.

-       We have started to work on the development of technology for somatic mutation profiling and Mutation-drug database.

-       We are currently exploring the regulatory requirements and planning the commercialisation activities.

Information published 28.12.2018.


1 January 2019 – 31 March 2019

  • We proceeded with the development of technology for somatic mutation profiling and Mutation-drug database.
  • We completed the preparatory work required to start the enrolment of patients in the project;
  • We carry on the exploration of the regulatory requirements and planning the commercialisation activities;
  • Members of the team participated in the Research commercialisation workshop organised by LIAA and visited SciLifeLab at Karolinska Institutet and Uppsala Innovation Centre. 

Information published 29.03.2019.


Progress of the project:

1 April 2019 – 30 June 2019

-        Assessment of the analytical performance of the somatic mutation profiling technology using cell cultures has been started;

-        Optimisation of the liquid biopsy technology is in progress;

-        A contract on the biobanking has been concluded and the enrolment of the patients has been started;

-        Genetic testing of clinical samples has been approved by CMĒK.

-        The exploration of the regulatory requirements and planning the commercialisation activities is in progress.

Information published 28.06.2019.


Progress of the project:

1 July 2019 – 30 September 2019

-                The somatic mutation profiling technology was tested in breast cancer and fibroblast cell cultures in order to determine its analytical performance. The data analysis is in progress and SOPs for the processing and analysis of the data are being developed.

-                The enrolment of patients was continued.

-                Testing of somatic mutation profiling technology in patients’ tumour tissue samples has been started.

-                Method for the isolation of cfDNA from plasma samples has been optimised.

-                Analysis of commercialisation scenarios is in progress.

Information published 30.09.2019.

Mājas lapas izstrādi finansēja ERAF aktivitātes projekts Nr. 2010/0196/2DP/ "Latvijas biomedicīnas pētījumu integrācija Eiropas zinātnes telpā".