Diagnostic test to enable personalized medicine in cancer

Summary

RAD51predict is a diagnostic test to accurately select patients with cancer who could benefit from a novel and very effective targeted therapy known as PARP inhibitors. These drugs are currently approved for specific subtypes of breast and ovarian cancer and it is estimated that over ten percent of all cancer patients could benefit from PARP inhibitors.

To date, the selection of patients is primarily based on prior platinum sensitivity and genetic tests. These tests have demonstrated a limited predictive value and restrict the use of PARP inhibitors to specific tumour subtypes. Therefore, novel predictive biomarkers are needed.

RAD51predict is a quick and low-cost immunoassay that identifies key biomarkers in tumour cells. This new diagnostic test will help to extend the use of PARP inhibitors to novel indications and guide oncologists with treatment recommendations. Overall, RAD51predict will contribute to personalizing the treatment of patients with cancer.

Achievements

  • In 2014, we started the setup of the assay and obtained the first promising results
  • In 2017, we filed a patent and, in 2018, we extended this protection with a PCT application.
  • In 2017, thanks to a CaixaImpulse Validate grant,we performed a market study that estimates the use of 800,000 tests/year with a sales potential of €400. Initially called PARPiPRED, the project name was updated to convey new uses for the test.
  • In 2018, we published two preclinical studies that validated our test in predicting response to PARP inhibitors in breast and ovarian cancers.
  • Since 2019, our test has been included in clinical trials with PARP inhibitors and we extended the clinical validation and feasibility in other tumour types, including prostate, pancreatic and lung cancers.

Next Steps

Thanks to the CaixaImpulse Consolidate grant, we will now advance towards obtaining regulatory approval of the RAD51predict test, a key step before its implementation in clinical practice. Among other activities, we will define the regulatory roadmap and quality management plan, and initiate a prospective clinical trial in which patients with breast cancer will be enrolled and treated with PARP inhibitors based on the results of the test.

We expect to reach the healthcare market within the next five years, with subsequent sequential approval in different tumour types. In parallel, we are exploring other potential uses of the RAD51predict test and its performance to predict response to other anti-cancer therapies.

Team

Project Leader. Associate Research Scientist

Alba Llop Guevara

Vall d'Hebron Institute of Oncology

Project leader

Principal Investigator

Violeta Serra Elizalde

Vall d'Hebron Institute of Oncology

Clinical Oncologist and Principal Investigator

Judith Balmaña Gelpi

Vall d'Hebron Institute of Oncology

Business Development Manager

Carlos López Arranz

Vall d'Hebron Institute of Oncology

Partners

Validate-17
Consolidate-19

Scientific Area

Clinical sciences

Business area

Diagnostic

Research center

Vall d’Hebron Institute of Oncology