Technology

VERIDAPT DX™ is a predictive biomarker for optimizing early-stage cancer therapy.

The VERIDAPT DX biomarker platform measures solid tumor response to neoadjuvant cancer treatment.
 
Now in clinical trials for breast cancer, VERIDAPT DX predicts with a high degree of certainty (Negative Predictive Value >93%) whether a patient will benefit from a selected therapy. 
 
Physicians can use this information to escalate or de-escalate therapy for better patient outcomes.

Assess tumor response as early as 5 weeks into treatment

THE SCIENCE

RNA disruption signals tumor cell death.

VERIDAPT DX is a molecular diagnostic test that measures the level of ribosomal RNA (rRNA) disruption in solid tumors.

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rRNA disruption is considered a universal measure of tumor cell death, regardless of changes in tumor size and volume, tumor type or treatment.

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Studies to date show that RNA disruption is a better predictor of treatment efficacy than pathologic Complete Response (pCR), the current gold standard for treatment efficacy prediction.

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rRNA will be highly disrupted if cancer drugs are working. If the cancer drugs are not working, the rRNA will be intact.

How VERIDAPT DX works

  • RNA is isolated from the biopsy sample and assessed for RNA disruption
  • The VERIDAPT DX platform detects fragmentation of rRNA using capillary electrophoresis instrumentation 
  • The data is quantified using a proprietary algorithm.
  • Results are expressed as an RNA Disruption Index (RDI) score.

 

Practicing oncology has become more and more an art because it is important to tailor treatment for each individual patient; we owe it to our patients. If validated in the ongoing phase 2 of the study, the VERIDAPT DX predictive biomarker test will become part of our daily practice, helping our patients to avoid futile treatments and healthcare systems to conserve spendings.

Dr. Marina Cazzaniga

Associate Professor of Oncology, School of Medicine and Surgery, University of Milano Bicocca, Co-Chair of BREVITY Steering Committee

Discovery Trial

The RDI Score

 The magnitude of RNA disruption is quantified by the RNA disruption index (RDI).
A higher level of RNA disruption indicates patients are responding to treatment. They have a higher likelihood of achieving pCR — the disappearance of all signs of cancer in response to treatment — and improved disease-free survival.

Response zones:

ZONE 1: Non-Responder: characterized by a low level of RNA disruption, indicating an ineffective therapeutic response, and a low likelihood of pCR or enhanced disease-free survival.

ZONE 2: Partial Responder: indicates an intermediate response.

ZONE 3: Responder, with a high level of RNA disruption, indicates a higher likelihood of achieving a pCR and enhanced disease-free survival.

RNA Disruption & Disease-free Survival

A strong association between rRNA disruption and treatment response was first established by the National Cancer Institute of Canada (NCIC) Clinical Trials Group.

Results of the NCIC-MA.22 trial (above), first published in 2015, laid the foundation for accurately predicting disease-free survival based on RDI score.

Since then, VERIDAPT DX has been evaluated in several retrospective and prospective trials.

BREVITY, a large-scale, international clinical validation trial focused on predicting treatment efficacy for early-stage breast cancer patients is now in Phase 2 at over 50 cancer centers in seven countries.