Genomic testing company, Guardant Health, has announced that it will develop a liquid biopsy panel comprised of over 500 genes to support both cancer drug development and clinical trials. The company has already established partnerships with several leading pharmaceutical companies, including AstraZeneca, Pfizer, and Merck.
The biopharma industry has historically relied on solid tissue biopsies as a source of cancer DNA, however this method can be expensive for clinical trial sponsors, and invasive for patients. Once it’s been developed, the cancer gene panel is expected to be the largest commercially available liquid biopsy of its kind.
The new test will apply Guardant Health’s sequencing platform with its liquid biopsy technology, known as Guardant360. The company expects to launch the liquid biopsy test in the middle of this year, with a Clinical Laboratory Improvement Amendments (CLIA)-certified version to be released shortly after.
“With Guardant360, we have pushed our Digital Sequencing platform to the biological limits of DNA sequencing sensitivity. In a number of cases, we are now confidently detecting a single molecule of mutant circulating tumor DNA in a 10mL tube of blood drawn from an advanced cancer patient,” said Helmy Eltoukhy, Guardant Health CEO and co-founder. “Now we are applying this same underlying technology to ten times as many genomic targets in an effort to speed drug development. The result for which we are aiming is that effective drugs will get to market faster and help patients sooner.”
According to Guardant Health, the 500-plus-gene liquid biopsy will allow investigators to use a single blood sample to sort patients into multiple clinical trial options. In addition, the tool is expected to allow for real-time monitoring of tumor response to treatment during the course of a clinical trial.
“This could potentially be a very important tool for anyone conducting clinical trials in oncology,” said Dr. John Heymach, Chairman of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. “With one test, we could screen patients for virtually every targeted therapy clinical trial available, monitor their response, and determine how the tumor evolves and if it develops resistance to treatment. This panel may ultimately be of great use in helping guide the use of immunotherapy as well.”
Guardant Health’s Guardant360 test was launched in 2014 and is considered to be the most sensitive commercially available liquid biopsy for cancer. Last year, the company launched Project LUNAR in an effort to determine whether the liquid biopsy could be used to detect and diagnose early-stage cancer.