In a press release on June 6, guardant Health, Samsung Medical Center (Medical School of Sungkyunkwan University, Korea), reports successfully NEXT-2 clinical trial of 200 patients with advanced cancer. The study used a liquid biopsy to test the feasibility of using "as the only diagnostic tool" to guide oncologists to match patients to therapies for many cancers, "demonstrated high actionability to match patients to targeted therapies, as well as the statistically significant response levels in the lung (88%) and gastric (60%) cancers. "
"The results we have seen have been remarkable and certainly exceeded our expectations," said Dr. Lee Jeeyun at Samsung Medical Center, the lead researcher of the study.
The NEXT-2 trial used the Guardant360 technology - the first and only liquid biopsy, which covers all 70 biomarkers recommended guidelines in a single test, according guardant. The next step is to guardant refine their technology to show that it can actually detect previously undetected cancers in high-risk patients such as smokers. Potentially, this technology can be used in other high-risk patients such as those previously exposed to asbestos, for detecting mesothelioma.
Furthermore, in an article on June 4 Time, guardant reported encouraging results from a study of 15,000 patients who were tested with Guardant360. The team was able to identify cancer mutations in more than two thirds of patients where existing treatments are available. In comparison with a traditional tissue biopsy, blood tests were 98% accurate.
On 1 June, the US Food and Drug Administration announced approval of the first test liquid biopsy for detecting the EGFR mutation in patients with lung cancer. The cobas EGFR Mutation Test v2 is a companion diagnostic for the drug against cancer Tarceva (erlotinib), an inhibitor of the tyrosine kinase EGFR to treat lung cancer and mesothelioma.
The FDA noted that tumor DNA actually puts a tumor into the blood stream, allowing a liquid biopsy, or a blood test, which must be used to detect cancerous mutations. At present, there is no effective non-invasive methods for early detection or monitoring of treatment or for the lung cancer and mesothelioma. However, a blood test can be used for the detection, treatment monitoring, and for identifying the appropriate treatment protocol.
"Approvals liquid biopsy tests can provide highly individualized care for patients," said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostic and Radiological Health at the FDA's Center for devices and radiological health. "liquid biopsies also have the option to enable doctors to identify patients whose tumors have specific mutations in the least invasive way possible."
"This is a great day for patients," said Helmy Eltoukhy, co-founder and CEO of guardant Health. "With the evidence that liquid biopsies are both consistent with the tissue, and useful for treatment, clinicians have a tool for genotyping that is not with it economic harm and potential repetition of invasive biopsies. "
