Joint study will assess clinical value of comprehensive genomic profiling (CGP) on cancer therapy options in patients with advanced disease
SAN DIEGO, Feb. 3, 2022 /PRNewswire/ -- Illumina, Inc. (NASDAQ:ILMN), today announced an agreement with the Jean Perrin Center at the Clermont-Ferrand University Hospital in France to assess the clinical value of comprehensive genomic profiling (CGP) in cancer therapy options in patients with late-stage disease compared to use of current standard of care, including small panel tests. Evidence from the CELIA (comprehensive genomic profiling impact) research study will be used to support a precision medicine approach for patients with late-stage cancer within the French healthcare system.
The Jean Perrin Center, with participation from the Toulouse Oncopole and the Bordeaux University Hospital Center, will analyze biopsy samples from patients with advanced colorectal, breast, melanoma or lung cancer using CGP enabled by Illumina's TruSight™ Oncology 500 assay.
"We are pleased to be working with the Jean Perrin Center which is leading this important study that will contribute to the growing international evidence base that puts CGP at the forefront of precision oncology medicine," said Phil Febbo, MD, Chief Medical Officer at Illumina. "By assessing many mutations and biomarkers simultaneously to reveal the unique molecular profile of a tumor, CGP is helping to rapidly deliver actionable insights to patients and physicians, and improve outcomes."
TruSight™ Oncology 500 assay can look for the presence of mutations and biomarkers from over 500 genes simultaneously to reveal the specific molecular profile of a cancer sample. This profile can then be matched against precision medicine treatments known to act on specific gene alterations or biomarkers. This approach will be compared by researchers with standard of care testing, including small panel tests that cover a limited range of biomarkers of interest for each cancer type.
"CGP is being increasingly used in cancer centers throughout Europe, including France. Our goal is to confirm the clear clinical utility in order to make next-generation sequencing for metastatic cancer more broadly included in European and national clinical guidelines," said Professor Frédérique Penault-Llorca, General Director of the Jean Perrin Center, and coordinator of the CELIA study. "Data from the CELIA study will add to the growing body of evidence on CGP, with the aim of accelerating the adoption of precision medicine for cancer patients. We are grateful for Illumina's contribution to this project."
"Personalized treatments that target cancer mutations have improved prognosis greatly, helping us direct patients to the best option for them," explained Professor Pascal Pujol, President of the French Society for Predictive and Personalized Medicine, and Head of the Oncogenetics Department at Montpellier University Hospital. "It is critical to ensure that the use of comprehensive analysis based on large DNA and RNA panels becomes part of routine practice so that patients can benefit from the best possible care."
SeqOne Genomics, a French deep tech company offering high performance genomic analysis solutions, has been selected by the three centers for analysis of the data and generation of clinical reports that outline possible treatment options and clinical trial eligibility. Illumina is providing sequencing reagents and biostatistician expertise.
About TruSight Oncology 500 Portfolio
TSO 500 is a Research Use Only pan-cancer assay that enables Comprehensive Genomic Profiling from tissue biopsy samples. Designed to identify known and emerging tumor biomarkers across 523 genes, TSO 500 utilizes both DNA and RNA from tumor samples to identify key variants critical for cancer development and progression, such as small DNA variants, fusions, and splice variants. In addition, the assay assesses key immune-oncology biomarkers, such as Tumor Mutational Burden (TMB) and Microsatellite Instability (MSI). TSO 500 ctDNA shares similar DNA panel content design to the tissue-based assay but utilizes ctDNA from blood as input material. Due to the TSO 500 portfolio's comprehensive biomarker content, labs can consolidate multiple single gene or small panel workflows into a single assay, saving biopsy specimen and time. Based on the content of TSO 500, Illumina will be adding an in vitro diagnostic (IVD) test to the TSO portfolio. This comprehensive tissue-based tumor profiling assay will have similar chemistry and analytics to TSO 500. To learn more about the TSO 500 portfolio, click here.
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments. To learn more, visit www.illumina.com and connect with us on Twitter, Facebook, LinkedIn, Instagram, and YouTube.
Dr. Karen Birmingham
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SOURCE Illumina, Inc.