Liquid Biopsy: The FRESH Program

Gustave Roussy’s liquid biopsy genomic profiling program is open to all patients in France, including those in overseas territories.

The overall goal of the FRESH program is to provide people with cancer access to personalized treatment options, including access to promising innovative therapies based on a molecular profile of their tumor.  

Access to precision medicine throughout France is made possible by liquid biopsy, which allows for genomic tumor profiling using a simple blood draw. It is a non-invasive method capable of identifying genomic abnormalities in tumor DNA present in a patient’s blood with high precision. It offers an alternative to traditional tissue biopsies and is particularly beneficial for patients whose tumors are difficult to access or whose health condition precludes invasive procedures. Analysis and reporting of results are also much faster (15 days on average).

With experience from more than 7,000 patient enrollments—in the STING and PRISM trials—Gustave Roussy has decided to invest heavily in a liquid biopsy program to serve patients with advanced metastatic cancers. This program combines access to cutting-edge technology in a clinical laboratory setting with the therapeutic interpretation of the information obtained by a multidisciplinary team of oncology experts.

Launched in July 2024, the FRESH program is the result of an ambitious public-private partnership between Gustave Roussy, Roche, and Foundation Medicine (FMI). It aims to roll out precision medicine through liquid biopsy throughout France. The goal is to establish and unite a national network of healthcare centers to improve equitable access to care across the country and to conduct ambitious oncology research projects with these partner healthcare centers.

At the heart of the FRESH program are two key differentiating strengths. First, a genomic profiling laboratory has been established within Gustave Roussy’s Department of Medical Biology and Pathology, in the Tumor Genetics Unit. It uses the FoundationOne Liquid CDx (F1LCDx) test, which analyzes a panel of more than 300 genes to identify genomic alterations that cause the onset or progression of cancers. Nationally, this test is available exclusively at Gustave Roussy. Furthermore, the interpretation of results is based on extensive expertise in both mutation analysis and treatment guidance.

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Video explanation of the Fresh program

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The process within the FRESH program is as follows:

• Blood draw: To perform the tumor analysis, a blood sample is collected at the healthcare facility where the patient is being treated.
• Sending the blood tubes: The laboratory that drew the blood sends the tubes to Gustave Roussy and enters the request into a digital portal called Netsig.
• Genomic analysis: The blood samples are then prepared and analyzed in the Tumor Genetics Department at Gustave Roussy by the team dedicated to the genomic profiling of liquid biopsies, using state-of-the-art technology specifically optimized for analyzing circulating tumor DNA.
• Report Generation: The molecular analysis data are reviewed by French medical biologists in an accredited facility, and a medical biology report is issued within 15 days of receipt of the blood tubes at Gustave Roussy.
• Interpretation of Results and Treatment Recommendations: The medical biology report is then discussed during a multidisciplinary consultation meeting (molecular RCP) at Gustave Roussy and at partner healthcare centers. This weekly meeting brings together oncologists, clinical laboratory scientists, pathologists, and experts in precision medicine to propose appropriate treatments and clinical trials based on the detected molecular abnormalities, as well as the patient’s clinical and geographic situation.

Analysis of variants of interest by a medical biologist

The FRESH program, with a testing capacity of over 8,000 tests per year, has been operational since July 2024. Its goal is to make liquid biopsy and the F1LCDx test—one of the two liquid biopsy tests recognized by the FDA—available to all French hospitals, whether public or private, that wish to offer this solution to their patients.

Significant Needs in France

The need for molecular testing among French cancer patients was assessed in a survey conducted with academic experts and Unicancer teams. The survey found that genomic profiling tests account for a significant portion of these needs, affecting approximately 205,000 patients per year across 375,000 markers.

Treatment Planning

Regarding treatment planning, the participation of prescribing physicians (or staff) from outpatient centers is strongly encouraged as part of the FRESH program. This treatment planning meeting (RCPM at Gustave Roussy) is held virtually on a weekly basis. It enables a collegial decision to be reached on treatment options, particularly regarding open trials at the prescribing physician’s center or at centers closest to the patients’ homes, taking into account the patients’ molecular abnormalities, clinical status, and geographic location.

The partnership between Gustave Roussy and the referring center is formalized through a subcontracting agreement between the healthcare facility’s clinical laboratories and Gustave Roussy’s clinical laboratory.

Genomic profiling laboratory for liquid biopsies at Gustave Roussy, Novaseq 6000 sequencer

The FRESH program generates molecular data and organizes it, for each participating center, into a cBioPortal database.

Each prescribing healthcare facility in the FRESH program contributes to a shared database with clinical and biological annotations essential for generating recommendations from the therapeutic guidance meeting (RCPM) for their patients and for the subsequent use of the data. This database is made available to each participating center for research on their patients’ outcomes, as well as for queries across the entire database by indication, biomarker, or other criteria. More in-depth research projects are submitted to a multi-institutional steering committee for approval.

 
Patients can participate in the FRESH program as part of their routine care. However, clinical protocols are also associated with the FRESH program to aid in the collection of clinical data, with the goal of determining the clinical value of liquid biopsy and broad-range panels for patients with metastatic disease.

Clinical Trials

STING

The STING clinical trial enables patients with metastatic cancer being treated at Gustave Roussy to receive molecular profiling as part of the FRESH program, along with a treatment recommendation, in direct collaboration with Gustave Roussy’s early-phase trial programs.

Sponsored by Gustave Roussy, the trial has been approved by regulatory authorities; the principal investigator is Prof. Antoine Italiano.

 PRISM Portal

The goal of the PRISM Portal clinical trial is to build on the national momentum for evaluating liquid biopsy across the country by adding evidence of its clinical impact on the care of patients with metastatic cancer. Another objective is to discover new therapeutic approaches by identifying innovative biomarkers and developing targeted therapies based on them.

Sponsored by Gustave Roussy, the trial is part of the PRISM IHU and has been approved by regulatory authorities; the principal investigator is Dr. Benjamin Verret.

Academic Impact

The establishment of a national network, supported by the use of a unique database of genomic profiling via liquid biopsy, represents a major opportunity for academic advancement, in terms of scientific publications and France’s strategic positioning on the international stage. Governance for the secondary use of FRESH data is included within the IHU PRISM.

The FRESH program is supported by a multidisciplinary and highly qualified team.

Liquid Biopsy Genomic Profiling Laboratory

Department Head: Dr. Étienne Rouleau

Lead Engineer: Edouard Turlotte

Lead Biologist: Dr. Voreak Suybeng

Medical Biologists: Dr. Michael Degaud – Dr. Ludovic Lacroix

Contract and Order Management: Manuella Lopes

Logistics Managers: Natacha Castor, Joël Breton

Precision Medicine Program and RCPm

Director: Prof. Antoine Italiano

PRISM Portal

Program Director: Dr. Benjamin Verret

Scientific Director of the FRESH Program: Dr. Marie Morfouace