- The VHIO Epsilon test, developed by the Cancer Genomics Group at VHIO, is designed to detect fusions and analyze gene expression, and could be useful as a predictive biomarker in immunotherapy.
- With this extension of the ISO 15189 accreditation scope, the three molecular prescreening tests developed by the Genomics lab meet the requirements for use in clinical research.
- This test’s accreditation adds to the renewal, once again, of ISO 15189 accreditation for VHIO’s Cancer Genomics and Molecular Oncology laboratories.
VHIO Epsilon is a test developed by the Cancer Genomics lab at VHIO, designed for detecting gene fusions and analyzing expression levels of genes related to tumor processes. The analysis is performed through ultra-deep sequencing and hybrid capture, using a custom-designed probe panel developed internally by the lab.
“We have developed this test capable of detecting gene fusions and analyzing the expression of individual genes with the goal of having a new type of biomarker that can be useful to predict whether a patient will respond to immunotherapy treatment with immune checkpoint inhibitors, drug-conjugated antibodies (ADCs), or other immunotherapy strategies,” explains Dr. Ana Vivancos, head of the Cancer Genomics Group at VHIO.
“This tool is part of the testing portfolio we develop in our lab and apply within the context of the VHIO Advanced Molecular Diagnostics (DIAMAV) program,” the researcher explains. “The goal is to characterize the genomic profile of each patient’s tumor to guide more personalized and effective therapeutic decisions. The clinical applicability of these tests is key to advancing toward precision oncology that is truly integrated into clinical care.”
This accreditation recognizes not only the validity of the VHIO EPSILON test and the quality and reliability of its results, but also the technical competence of the Cancer Genomics lab personnel to perform it.
Commitment to quality and continuous improvement
The inclusion of the VHIO Epsilon test expands the scope of the flexible ISO 15189 accreditation originally granted by ENAC in 2016 for the activities conducted in the Cancer Genomics and Molecular Oncology laboratories and described in TECHNICAL ANNEX no. 1052/LE2022.
The extension of the accreditation scope with this new test adds to the renewal, once again, of ISO 15189 accreditation for the Cancer Genomics and Molecular Oncology laboratories. Compliance with this standard ensures that processes, the quality management system, and the laboratory environment meet internationally recognized standards.
Together, these achievements reflect VHIO’s commitment to quality, continuous improvement, and excellence, in line with the center’s quality policy, and strengthen VHIO’s role as a European leader in precision medicine.
In 2016, VHIO obtained its first flexible-scope ISO 15189 accreditation for the Amplicon Seq test, followed in 2020 by the extension to the VHIO-CARD-300 test, which analyzes the genomic profile in tumor tissue. In 2024, the VHIO360 liquid biopsy panel was added to the accreditation. With this new accreditation, VHIO—and in particular the Cancer Genomics lab—positions itself as one of the few centers in Europe with 100% of its molecular tests validated and accredited for clinical use.
“This accreditation is essential to ensure that the results we generate are reliable and reproducible. Moreover, it allows us to align with the requirements of the IVDR Regulation on in vitro diagnostic medical devices, which mandates that in-house IVD development and use by healthcare centers must take place within a quality management system in compliance with ISO 15189,” adds Deborah Grazia Lo Giacco, Head of the General Quality Unit and Laboratories at VHIO.
