Liquid Biopsy Test Signatera Poised to Transform Cancer Care and Reduce Unnecessary Treatments

Precision medicine is entering a new era in cancer treatment with technologies capable of detecting minimal residual disease (MRD). Leading the way is Signatera, a circulating tumor DNA (ctDNA) test developed by Palex, selected for inclusion in the INNOPASS program of the Innovation Access Program to the Catalan Health System (PASS). This innovative test analyzes tumor DNA fragments in the blood after surgery or other treatments, potentially anticipating relapses and guiding decisions about additional therapies.

How Signatera Works: Detecting Minimal Molecular Disease

Signatera is a highly sensitive and personalized MRD assay that utilizes ctDNA. It is custom designed for each patient to identify relapse earlier than standard care tools. CtDNA assessment is a powerful tool to determine the presence or absence of MRD. The test has been characterized in over 170 peer-reviewed publications and has been used on more than 300,000 patients. [Natera]

A Paradigm Shift in Clinical Practice

Carlos Hagen, medical director of Palex, believes this innovation represents a profound transformation in clinical practice. “The arrival of minimal molecular disease represents a revolution on multiple levels,” he explains. Unlike many therapeutic advances, Signatera is based on molecular diagnosis, changing how clinical decisions are made post-treatment.

This change is particularly significant since of the test’s ability to anticipate and its superior sensitivity compared to traditional techniques. “We are talking about a disruptive change based on a diagnostic method, and not on a drug as is usually the case,” Hagen points out.

Reducing Unnecessary Chemotherapy

A critical moment in cancer treatment occurs after surgery when doctors decide if additional treatments are needed to reduce relapse risk. Until now, these decisions relied on clinical and statistical criteria that didn’t always reflect a patient’s actual risk.

Signatera detects residual tumor cells not visible with conventional imaging. In cancers with high incidence, such as colorectal cancer, technologies like Signatera may represent the biggest change in clinical practice in decades.

Data suggests a significant proportion of patients could avoid adjuvant chemotherapy if more precise risk assessment tools were available. It is estimated that between 70% and 80% of patients with stage II colorectal cancer and between 40% and 60% of those with stage III may not require additional treatment after surgery. Signatera helps avoid overtreatment while identifying those who truly need it.

Scientific Validation and Adoption Challenges

Signatera concentrates more than 90% of scientific publications in the field of minimal molecular disease and has evidence from thousands of patients in clinical trials and real-world studies. [Natera] The Spanish Network of Health Technology Assessment Agencies (RedETS) has recently evaluated the role of these tools in clinical practice.

Despite its potential, adoption into healthcare systems isn’t always rapid. Hagen notes that current healthcare models historically developed around medications, creating difficulties in incorporating molecular diagnostics. Organizational barriers, economic limitations, and regulatory challenges also pose obstacles.

Collaboration is Key

Hagen emphasizes the need for close collaboration between technology companies, clinicians, evaluators, and health administrations. Palex aims to be a partner to the healthcare system, facilitating disruptive technologies adaptable to clinical needs.

Potential Cost Savings

Beyond clinical benefits, advanced biomarkers like Signatera can improve healthcare system sustainability. Analyses with local data estimate savings of more than 3,000 euros per patient, even with conservative usage models. Extrapolating these figures to patients with stage II colorectal cancer suggests a potential economic impact of approximately 50 million euros annually for the health system.

Other Technologies Selected for INNOPASS

Signatera is one of ten innovations selected for the INNOPASS program, which aims to facilitate access to innovative solutions within the Catalan healthcare system. Other selected solutions include ADmit Therapeutics, Aniling, eVISIO, Inbiomotion, Loop Dx, Mediktor, MiWEndo Solutions, and REVEAL GENOMICS.