Gliomark is the only nuclear medicine project to be funded under the SME Instrument Phase 2 in the field of clinical research for the validation of biomarkers and/or diagnostic medical devices.
The aim of the project is to clinically validate the permeability of the blood brain barrier (BBB) as an in vivo biomarker for the diagnosis and grading of brain tumours (gliomas).
It is unlike most other such projects in being implemented by two SMEs, ConsulTech of Germany and ProActina of Greece.
The objective will be accomplished by using a radiotracer and the imaging technique, Single-Photon Emission Computer Tomography (SPECT). The concept is based on original research carried out by a group led by Andreas Fotopoulos, professor of nuclear medicine at the University Hospital of Ionnina, Greece.
The EU grant is funding Phase II and Phase III clinical trials and the development of manufacturing process for the product. At the start of the project in August 2015, the project was at technology readiness level 6 – 7, on completion it will reach level 9.
The outputs of Gliomark will be a diagnostic kit that uses the radioisotope tetrofosmin for SPECT brain imaging. Current imaging techniques using computer tomography or magnetic resonance imaging are often not able to accurately distinguish gliomas from other diseases or lesions, while although more precise, positron emission tomography (PET) is costly and not widely available.
As a result, final confirmation of diagnosis and grading of brain tumours can only be done with an invasive brain biopsy. The Gliomark project aims to provide an easy-to-use non-invasive method for the differential diagnosis and grading of brain tumours.
Gliomas are rare cancers with poor prognosis. Gliomark will contribute to the goals of the International Rare Disease Research Consortium (IRDiRC), which has set the target of developing 200 new rare disease treatments by the year 2020, and the development of diagnostics for all rare diseases.
In support of this this goal, the SME partners will apply for an orphan diagnostic designation for Gliomark, which will guarantee 10 years of market exclusivity.
Under the Horizon 2020 SME Instrument Phase 2, funding is available for innovation projects underpinned by a sound and strategic business plan.
Activities funded in Phase 2 can include prototyping, miniaturisation, scaling-up, design, performance verification, testing, demonstration, development of pilot lines, validation for market replication, including other activities aimed at bringing innovation to investment readiness and maturity for market take-up.
The SME Instrument also funds Innovation and Business development coaching to help SMEs enhance their innovation capacity; align the project to the business development strategy; and develop the commercial/economic impact and long term sustainability.
EU business innovation coach Iordanis Arzimanoglou, who is advising on Gliomark project said the project is far-reaching and promising, with good prospects of commercialising an in vivo biomarker for differential diagnosis, prediction of recurrence and stratification of patients.
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