Roche announces global availability of blood-based genomic profiling test, FoundationOne Liquid

  • Liquid biopsy test can identify 70 of the most commonly mutated genes in solid tumours, as well as microsatellite instability
  • Many cancer patients have insufficient or inadequate tissue for genomic testing and so may benefit from FoundationOne Liquid
  • FoundationOne Liquid joins FoundationOne CDx to deliver a complementary portfolio which provides insights to personalise a patient’s treatment plan

Roche announced today the global availability of FoundationOne Liquid, a liquid biopsy test. 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 FoundationOne CDx, a 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.

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company, a member of the Roche Group, offers a full suite of comprehensive genomic profiling tests to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer.

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