2022-11-013 - EPI_THROMB - 4 VALIDATED PLASMA MIRNAS BIOMARKERS FOR THE PREDICTION AND DIAGNOSIS OF VENOUS THROMBOSIS

EPI_THROMB

2022-11-013

New validated microRNAs biomarkers effective in the prediction and diagnosis of thrombotic events. Diagnostic kit for the prediction and diagnosis of venous thrombosis events

The project is aligned with Environmental Social Governance.

The expected impact is to obtain a preventive diagnostic test and to be able to avoid these venous thrombosis events. By preventive diagnosis, high-risk patients can receive preventive medication and avoid the disease. Venous thromboembolism (VTE) is the second most common medical complication and a cause of excess length of hospital stay. Its incidence and economic burden are expected to increase as the population ages. Annual total health care costs in patients with VTE were comparable among the various US studies, from $33,20020 for a patient with DVT using data for 1997–2004 to $36,918 for a VTE event using data for 2008–2011.

Venous thromboembolism (VTE) is a condition that occurs when a blood clot forms in a vein. It is a complex condition and chronic disease with a highly heritable genetic component in people with acquired genetic disorders of hypercoagulation. VTE includes deep vein thrombosis (DVT) and pulmonary embolism (PE). It is estimated that 900,000 people could be affected each year in the US, and 60,000-100,000 die from DVT/PE. Current diagnostic methods for both DVT and PE are based in imaging techniques (MRI, PET, ultrasound, X-ray) and in-vitro procedures (D-dimer blood test) which cannot be used for predictive use.

The preferred business model is to license to a company that has the capabilities to develop the in vitro diagnostic test, to bring the Medical Device into further regulatory steps until approval and sell the devices through their established marketing capabilities. In the License agreement we will contemplate the costs of the scientific project and all the efforts performed by the researchers, as well as the inversion by the research institute.

There is a clear need to diagnose patients with a high risk to suffer venous thrombosis to be able to treat them preventable to avoid the disease. Current diagnostic methods are not very specific. This method allows the diagnosis/prognosis of those people who would not be detected to develop thrombosis through conventional risk factors, and also allows to assess the risk of recurrence of thrombosis in diagnosed patients.

The global venous thromboembolism treatment market is estimated to value at US$2.5 Bn by the end of 2031 from US$2.2 Bn estimated in 2024. The market is expected to secure a CAGR of 4.2% in the forthcoming years from 2024 to 2031. We target the diagnostic part of this market.

There is a need to continue mantaining National patents in order to protect the technology and to identify more possible licensees that could be interested in the diagnostic method

Licensing out the technology

The Diagnostic method is based on relevant signature of microRNA biomarkers, validated over 900 patient samples and with higher sensibility and specificity measures compared to D-dimer diagnostic method, which is much less specific.

Regulatory, technologic and economic barriers

Prototype of the In vitro diagnostic test need to be developed. Validation in regulatory settings for in vitro diagnostic medical devices for both Europe and USA (by licencee)

The biomarker diagnostic method has entered into EP and US National Phases (EP4114974A1, 11/01/2023; US2023/093652A1, 23/03/2023)

Patents: EP20382151.7 - Date: Mar 2nd, 2020

The successful completion of the project will result in a diagnostic kit for the prediction and diagnosis of venous thrombosis events, providing health care professionals with an efficient tool that supports them in the decision-making of thromboprophylaxis interventions. The project has already captured the attention of the industry and the explorations are being held with two international pharmaceutical companies. MiRNAs are of high scientific interest and many companies are aligning their portfolio to develop their assets in this field.