Roche Announces Global Availability of Blood-Based Genomic Profiling Test, FoundationOne Liquid
New liquid biopsy test can identify 70 of the most commonly mutated genes in solid tumours, as well as microsatellite instability
24 Sept 2018
Roche has announced the global availability of FoundationOne® Liquid, a liquid biopsy test. Many cancer patients have insufficient or inadequate tissue for genomic testing and may therefore benefit from FoundationOne Liquid. This new test joins FoundationOne CDx to deliver a complementary portfolio which provides insights to personalise a patient's treatment plan.
FoundationOne Liquid can identify circulating tumour DNA in the blood of people living with cancer and can identify 70 of the most commonly mutated genes in solid tumours, including microsatellite instability, a genomic signature which may help inform cancer immunotherapy-based treatment decisions. [1,2] From a single blood sample, the liquid biopsy offers a quick and convenient option for some patients with solid tumours. [3]
FoundationOne Liquid meets a compelling need for comprehensive genomic profiling for people who have insufficient or inadequate tissue, including those with advanced non-small cell lung cancer, where an estimated 15% of patients are not eligible for tissue biopsy and approximately 10% have a biopsy size that is insufficient to evaluate. [4-6] FoundationOne Liquid complements FoundationOne CDx, a tissue-based genomic profiling test launched in the US earlier this year, to deliver a portfolio of comprehensive genomic profiling services for healthcare professionals.
"Cancer is a disease of the genome and genomic profiling of every patient's tumour at the start of their treatment journey will provide transformative outcomes for patients," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "At Roche, we believe the use of innovative profiling technologies like FoundationOne Liquid and FoundationOne CDx will improve access to targeted cancer treatments for patients and enrich the future development of targeted medicines."
About FoundationOne Liquid
FoundationOne Liquid is a liquid biopsy circulating tumour DNA (ctDNA) test that complements the tissue-based test. The blood sample is sent to a Foundation Medicine lab where the test is performed using next generation sequencing to analyse the four main classes of genomic alterations as well as microsatellite instability, an indicator that may help inform immunotherapy treatment decisions using ctDNA isolated from plasma derived from peripheral whole blood.
About FoundationOne CDx
FoundationOne CDx is based on the first US Food and Drug Administration-approved broad companion diagnostic assay to assess the four main classes of genomic alterations and identify patients with advanced cancer who are likely to respond to targeted therapies based on their individual genomic profile. The tissue sample is sent to a Foundation Medicine lab where the test is performed using next generation sequencing to analyse the four main classes of genomic alterations, as well as microsatellite instability and tumour mutational burden, using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumour tissue specimens. The test has been validated with 2,100 clinical samples and 4,200 analytical samples. [7] FoundationOne CDx is intended to be used by clinicians as decision-making support in consideration of a patient's genomic profile for therapy selection and patient management according to professional guidelines in oncology for cancer patients.
References
[1] Foundation Medicine. FoundationOne Liquid Technical Specifications [Internet: accessed September 2018]. Available from: https://www.foundationmedicine.com/genomic-testing/foundation-one-liquid.
[2] Dudley JC, et al. Microsatellite Instability as a Biomarker for PD-1 Blockade. Clin Cancer Res. 2016; 22:813-20.
[3] Clark TA, et al. Analytical Validation of a Hybrid Capture-Based Next-Generation Sequencing Clinical Assay for Genomic Profiling of Cell-Free Circulating Tumor DNA. J Mol Diagn. 2018; S1525-1578(17)30527-5 [Epub ahead of print].
[4] Rafael OC, et al. Molecular Testing in Lung Cancer: Fine-Needle Aspiration Specimen Adequacy and Test Prioritization Prior to the CAP=IASLC=AMP Molecular Testing Guideline Publication. Cancer Cytopathology. 2014; 122(6):454-458.
[5] Douillard JY, et al. Gefitinib Treatment in EGFR Mutated Caucasian NSCLC. J Thorac Oncol. 2014; 9:1345-1353.
[6] Kim ES, et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet. 2008; 372:1809-18.
[7] Foundation Medicine website: FoundationOne CDx - "Go Beyond FoundationOne®" [Internet: accessed September 2018]. Available from: https://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.