Companion Diagnostic Labels for Guardant360 CDx and FoundationOne Liquid CDxįor instance, FoundationOne Liquid CDx checks for a genetic feature called microsatellite instability. Some of the additional genetic changes covered by the tests are targeted by FDA-approved therapies, but the tests don’t have companion diagnostic designations for those therapies. Clinical studies to support additional companion diagnostic labels for both tests are ongoing. FoundationOne Liquid CDx, made by Foundation Medicine, was approved as a companion diagnostic for three lung cancer therapies and a prostate cancer therapy. Guardant360 CDx, made by Guardant Health, was approved as a companion diagnostic for osimertinib (Tagrisso), a lung cancer therapy. In this case, the tests determine whether a patient’s tumor has a genetic change that is targeted by a specific drug. A test is considered a companion diagnostic if it provides key information about the safe and effective use of a corresponding drug. The data showed that the results of both tests agreed with results from other tumor profiling tests that have been proven accurate.īoth tests can be used for two different purposes: as a companion diagnostic test and for general tumor profiling. The approvals were based on data from hundreds of patients with a range of cancer types. Companion Diagnostics and General Tumor ProfilingįDA approved Guardant360 CDx on August 7 and FoundationOne Liquid CDx on August 26. It’s great for patients it’s easier to get,” he said. “It’s great that we’ve crossed that hurdle now. Park explained, is validation that the results of a blood-based tumor profiling test can be used to guide the selection of a targeted therapy.
What the FDA’s stamp of approval provides, Dr. Many details about how the blood tests may be incorporated into everyday care for people with cancer, including who should get them and whether the cost is covered by private insurance companies, are still being ironed out. “Even though the tests have been around for a while, we don’t know how useful they’re really going to be in the clinical setting,” said Ben Ho Park, M.D., Ph.D., of Vanderbilt-Ingram Cancer Center. They are considered less invasive and quicker than a traditional tissue biopsy. Liquid biopsies can sometimes be an alternative to a traditional biopsy, in which a sample of a tumor is removed with a needle or during surgery. While FDA has approved other blood tests that check for the presence a single gene mutation in tumor DNA, these are the first approved blood tests that check for multiple cancer-related genetic changes. Analyzing genetic changes in a patient’s cancer is called tumor profiling, genomic profiling, or tumor sequencing.īoth Guardant360 CDx and FoundationOne Liquid CDx are approved for people with any solid cancer (e.g., lung, prostate), but not for those with blood cancers. The newly approved tests identify genetic changes, including mutations, by scanning DNA that tumors have shed into the blood.ĭoctors can then use that information to determine if there is a targeted therapy or immunotherapy that is likely to work for the patient. Now they often use another feature to guide treatment: genetic changes in the tumor.Ĭertain therapies, called targeted therapies and immunotherapies, work best against tumors that have specific genetic changes. The tests, Guardant360 CDx and FoundationOne Liquid CDx, are made by different companies and were approved separately.ĭoctors have traditionally based treatment decisions on features like the organ in which the cancer started growing, whether the cancer has spread, and whether the patient has other health conditions. The Food and Drug Administration (FDA) has approved two blood tests, known as liquid biopsies, that can help guide treatment decisions for people with cancer.
Credit: Adapted from World J Gastroenterol.
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