VIENNA, Dec. 5, 2016 – Guardant Health reported the results of the largest ever genomic study of advanced non-small cell lung cancer (NSCLC) patient cell-free circulating tumor DNA (ctDNA) at the 17th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (IASLC).

“It is clear from this retrospective data set that comprehensive genomic profiling performed in shed tumor DNA isolated from patient plasma can provide reliable, actionable information that can be used to guide treatment decision-making in metastatic lung cancer” said Philip Mack, PhD, UC Davis Director of Molecular Pharmacology, who presented the study.

The study looked at the genomic landscape reported by Guardant360 across more than 8,000 advanced NSCLC patients. It demonstrated that mutations in genes that frequently drive NSCLC, such as EGFR, KRAS, ALK, and ROS1, were detected by Guardant360 at very similar frequencies to the alterations found in The Cancer Genome Atlas, a public database of cancer genomics drawn from tissue samples from patients who had not yet been treated or had early-stage cancer. These data indicate that Guardant360 provides an accurate snapshot of the genomic landscape of the tumor. In contrast, the mutations that develop in response to treatment and often lead to resistance were rarely seen in the largely treatment-naïve TCGA population, but were detected by Guardant360 at rates consistent with the published literature.

The study also demonstrated the high accuracy of Guardant360 mutation identification. In a sub analysis of 229 samples for which matched tissue sequencing results were available, when Guardant360 identified an actionable alteration it was confirmed in tissue genotyping 92% to 100% of the time. Additionally, Guardant360 identified previously undetected actionable alterations in 28% of patients who had undergone uninformative invasive biopsy-based genomic testing.

“Molecular testing in lung cancer is in rapid transition from tissue testing to plasma cell-free DNA,” said Dr. David Gandara, director of the Thoracic Oncology Program at the UC Davis Comprehensive Cancer Center. “These are exciting findings for any oncologist seeing patients with advanced lung cancer. They not only show that Guardant360 finds what doctors would expect to find, but that the test frequently detects these critical alterations in patients when earlier tissue testing fell short.”

A comprehensive, highly sensitive liquid biopsy may be the best way to assess the genomic status of advanced NSCLC patients at progression. With the average cost of a lung biopsy exceeding $14,600, and industry guidelines calling for doctors to perform comprehensive genomic testing at progression, these results suggest there is great value in reliably acquiring genomic information through a simple blood draw.

“Almost one third of advanced NSCLC patients do not undergo basic EGFR and ALK testing, and 85% do not get the broad molecular profiling called for in national guidelines. Now we can help patients get access to the much better outcomes associated with targeted therapies without the risk from a repeat invasive tissue biopsy,” said Dr. Richard Lanman, Chief Medical Officer of Guardant Health and a co-author of the study. “Indeed, the guidelines now recognize that plasma testing should be considered when tissue is unavailable”

Guardant360 the most validated comprehensive liquid biopsy, and was the first to be introduced in 2014. It has since been used by more than 3,000 oncologists to identify somatic genomic alterations associated with targeted therapies in the ctDNA of more than 30,000 patients with advanced cancer.

“These results affirm what thousands of Guardant360 customers already know,” said Helmy Eltoukhy, CEO of Guardant Health. “Guardant360 is a comprehensive, accurate, and sensitive test that helps patients and doctors reach the best treatment decisions with minimal risk and has the potential to replace repeat tissue biopsies as the gold standard in lung cancer.”

About Guardant Health
Guardant Health is focused on conquering cancer with breakthrough blood-based assays, vast data sets, and advanced analytics. Using both molecular and digital tools, Guardant Health is addressing challenges across the cancer care continuum. The company has raised more than $200 million from leading venture capital firms. Its first product, Guardant360, came to market in 2014, and is now the most validated and sensitive comprehensive liquid biopsy commercially available.