US-FDA Approved Foundation Medicine’s FoundationOne®Liquid CDx, a Pan-Tumor Liquid Biopsy Genomic Test for Late Stage Cancer Patients now Available in India

US-FDA Approved Foundation Medicine’s FoundationOne®Liquid CDx, a Pan-Tumor Liquid Biopsy Genomic Test for Late Stage Cancer Patients now Available in India

Roche Products (India) Pvt. Ltd. (Roche Pharma India) announces the launch of FoundationOne®Liquid CDx, Foundation Medicine’s comprehensive pan-tumor liquid biopsy test for patients with solid tumors in India. US FDA approved the FoundationOne®Liquid CDx, a comprehensive genomic profiling (CGP) test on August 26. This is the first test that can analyze more than 300 genes and multiple genomic signatures to optimize patient care.

Cancer is a disease of the genome. Most tumors harbor a constellation of genomic alterations that may dictate their clinical behavior and treatment response. Blood-based biomarker testing options like FoundationOne®Liquid CDx can help expand access to genomic insights in patients with advanced cancer as compared to a tissue biopsy, which may not be an option for many patients due to reasons such as tumor location and patient’s health status. FoundationOne®Liquid CDx is a single non-invasive test based on Next Generation Sequencing technology that gives access to genomic information of over 300 genes. Additionally, the report also provides information about the biomarker signatures microsatellite instability (MSI), and blood tumor mutational burden (bTMB) to support informed decision making for targeted and immunotherapies.

“Roche has always been committed to provide best-in-class solutions to serve the needs of cancer patients globally as well as in India. We believe that cancer patients in our country and their physicians deserve the highest quality genomic testing to guide personalized treatment decisions. We are delighted to make this test now available for Indian patients, post US-FDA approval.” said Mr. V. Simpson Emmanuel, Managing Director, Roche Pharma India.

Elucidating the nature of the genomic alterations has led to an increase in discovery of many targeted therapy options for patients in recent years. It is becoming increasingly important to provide personalised treatment options to the patients as it has an unprecedented scope in changing the paradigm of cancer care in the future.

“US FDA approved FoundationOne®Liquid CDx is a comprehensive genomic profiling test that reports genomic alteration results of more than 300 genes, including genomic signatures such as blood tumor mutational burden (bTMB) and microsatellite instability (MSI), as well as all NTRK fusions* for any solid tumor with a single blood draw. It will enable more rapid and informed treatment decisions at the point of care.” said Dr. Bruno Jolain, Director – Medical, Roche Pharma India.

FoundationOne®Liquid CDx is mainly prescribed in the metastatic cancers i.e. at stage IV of the disease. The test samples collected from the patients in India are sent to Foundation Medicine Inc.’s lab in Cambridge, MA, US where the test is performed. The patients are required to discuss with their treating physicians on their eligibility for this test.

“Liquid biopsy is becoming an increasingly important and convenient molecular diagnostic technique both at initial diagnosis as well as during follow-up. From a clinical perspective, I believe physicians should discuss tumor genomic profiling with every eligible patient to guide use of targeted and immunotherapy.” said Dr. Suresh Advani, a leading Mumbai based oncologist.

The total disease burden of cancer in India is anticipated to increase significantly from about 1 million new cases in 2012 to more than 1.7 million per year by 2035. [1] With such an alarming trend, it is becoming increasingly important to shift towards new treatment approaches like personalized medicine.

Leave a Reply

Your email address will not be published. Required fields are marked *