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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - ONCOCHECK (A simple blood test for prognosis and monitoring of patients undergoing cancer therapy.)

Teaser

Summary

ONCOCHECKâ€™s main objective is to prove the clinical value of telomere-associated variables (TAVs) as biomarkers for cancer management. The project is divided in a series of clinical studies including hematological and solid tumors in adults and children.

In the new era of personalized medicine cancer management needs better diagnostic, prognostic and monitoring tools. Doctors need to be able to make earlier and more accurate decisions that can help to improve cancer patient individualÂ´s management. Integrating telomere associated variables in cancer care will lead to improved outcomes.

In oncology screening false positive and false negatives are misleading, other times there is no clear mean to predict who is going to have a more aggressive form of the disease or which patients will respond to therapy. Clinical data and the accuracy of current screening tools will be enhanced with TAVs, by an easy blood test performed at diagnostic and then at each routine check-up to anticipate disease progression. PatientÂ´s TAVS profile could indicate who will benefit from specific treatments. In fact, less invasive procedures for early detection will save payers and improve patientÂ´s quality of life while providing powerful tools to guide physicians during cancer follow up and helping to give the right drug to the right person.

Work performed

During the second period (M12-M24) and along the whole duration of it (M1-M24) of the project we have sequentially achieved each and every single milestone as stated in the proposal. Following Ethics approval for the different clinical studies over 30 clinical sites were initiated to recruit subjects for the different studies including controls.

Over 5000 samples have been obtained from all of the studies combined, processed and analyzed in what has been the greatest telomere-based clinical study ever conducted.

A machine learning data analysis and validation of the results has rendered prediction models on specific groups of patients from the different studies demonstrating the clinical significance of TAVs. In particular, the application of TAVs as a risk-score based biomarker to save unnecessary biopsies in prostate cancer detection grants the next phase of clinical development of our test for market approval.

A dedicated webpage and brand registration for ONCOCHECK were created as active platforms to disseminate our work. Communication has been reinforced with abstract presented to oncology international meetings, business development at BIO-specific conferences, press releases and webinars as well as social media activities; blogs and tweets that have been constantly updated until month 24.
Most importantly, the work performed in the project and the results have also allowed us to reinforce our IP position with the filling of a European patent application in December 2018.

Life Length has undergone its revalidation as Medical Laboratory (CLIA, ISO15189, A2LA and Spanish Health Ministry) successfully twice during the Oncocheck project; in 2017 and in 2018, which ensures the quality of the clinical development of the TAVs platform into oncology biomarkers.

Final results

The ONCOCHECK test is as a new tool for the in vitro diagnostic/monitoring of cancer - in particular it is included within the cellular health screening market. Global Industry Analysis in this sector forecast and steady demand for biomarkers and a clear tendency for the use of combination of biomarkers as cancer is no longer seen as a single disease; each patient is unique in the onset, evolution and response to treatment.

The ability to position telomere associated variables (TAV) in the Next Generation Cancer Diagnostics Market will bring a unique set of diagnostics techniques to offer a more sustainable and effective way for disease diagnosis, prognosis and monitoring.

The use of analytically validated technologies and clinical monitoring to produce data of the highest quality has allowed us to perform machine learning protocols that achieved, ultimately, algorithms to guide doctors on their clinical oncology practice. The simplicity of the test (i.e.: blood samples vs. imaging technology) facilitate its adoption and will result in significant savings for the payers and improved clinical outcomes.