X-10 Pathology, Empowering diagnostics

Project Information

X-10 Pathology

Grant agreement ID: 734969

DOI

10.3030/734969

Project closed

EC signature date 11 July 2016

Start date 1 August 2016

End date 31 December 2016

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

GRADEMI BIOTECH SRL
Italy

Periodic Reporting for period 1 - X-10 Pathology (X-10 Pathology, Empowering diagnostics)

Reporting period: 2016-08-01 to 2016-12-31

Summary of the context and overall objectives of the project

X-10 Pathology is a novel point-of-care in vitro diagnostic (IVD) instrument that is unique in its ability to specifically diagnose a set of inflammatory conditions with a single, inexpensive blood test.
The late diagnosis of inflammatory pathologies, such as cancer and autoimmune diseases, puts undue burden on patients, caregivers, and healthcare systems. This year alone, more than 50 million people around the world will be diagnosed with an inflammatory disease. Patients, caregivers, and healthcare systems are increasingly demanding diagnostic tools that are cheaper, faster, and more accurate than existing technologies.
The mission of Grademi Biotech is to improve the quality of life of patients who are suffering from inflammatory diseases by reducing the need for long series of medical tests and specialist consultations before obtaining a reliable treatment.

Our vision is to extend this improvement in quality of life to all patients with inflammatory diseases worldwide, and to help reduce the global cost of healthcare.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During the course of the Feasibility Study we have validated X-10 Pathology’s ability to diagnose two diseases in collaboration with the Hospital San Raffaele in Milan, Italy. The data collected during this stage show that, using X-10 Pathology on a large collection of blood samples, (A) patients with these two diseases can be distinguished from healthy patients and (B) that the two diseases may be readily distinguished from each other. Preliminary statistical analysis has provided an initial model of the reference curves for these two diseases, which will be further refined by recruiting more patients during the course of Phase 2.

Additionally, to ensure that all samples undergo identical treatment prior to analysis we have designed a sample shaker to be sold with the X-10 Pathology instrument. The shaker will hold 8 samples –the same as the X-10 Pathology apparatus – and will allow for adjustments to be made to the sample speed, shaking time, and sample angle.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The technical advances made during the project so far, along with our greater understanding of the IVD market at large, indicate to us that X-10 Pathology could have a large impact on healthcare both in the developed and developing world. The implications of our success would mean faster and cheaper access to important diagnostic decisions for a large number of underserved patients.

image-1.png