Biodesix, Inc. has launched its targeted liquid biopsy mutation test for patients with advanced lung cancer.

The molecular diagnostics company announced the launch of GeneStrat, a targeted liquid biopsy mutation test for genotyping tumors of patients with advanced non-small cell lung cancer (NSCLC). The results from the blood test are available within 72 hours, providing physicians with diagnostic information to use before making treatment decisions.

GeneStrat is focused exclusively on the clinically actionable EGFR, KRAS, and BRAF mutations often used to guide targeted therapy treatment decision. The test also captures the EGFR T790M mutation, which can be used for monitoring the emergency of the primary resistance mutation in the EGFR gene. There are two drugs in development that are targeting the resistance mutation, which may be available later this year.

According to Biodesix, about 30 percent of patients with lung cancer either have insufficient biopsy tissue or are not candidates for a biopsy for tumor mutation profiling. Even in cases where tissue biopsy is available, early treatment is necessary. One study showed that only one of four patients start cancer treatment before receiving mutation test results.

GeneStrat offers a fast, minimally invasive alternative to high-risk tissue biopsy or re-biopsy in patients with insufficient tissue. The test requires only a blood draw, and uses the ddPCR platform to analyze the cell-free tumor DNA. It is highly concordant with tissue analysis and currently considered the gold standard. Additionally, liquid biopsy can be more cost-effective than traditional tissue biopsies. The average cost of each tissue biopsy is $14,634 across all patients, however the cost can be up to four times higher in the 19.3 percent of patients who have complications associated with the biopsy. The liquid biopsy can help avoid the cost and complications of repeat tissue biopsy.

“Being diagnosed within 72 hours of a blood test is critical to rapid treatment decisions, as over half of the people with lung cancer die within one year of their initial diagnosis,” said Biodesix CEO Davis Brunel. “GeneStrat provides the tumor mutation profile at the time of diagnosis and can be used to monitor resistance by tracking the rise of the EGFR T790M mutation. For a more complete picture of the patient’s disease, GeneStrat can also be paired with VeriStrat®, which captures the host response to the tumor – prognostic information early in treatment planning and predictive information for patients who are ineligible for platinum doublet chemotherapy or after progression on first line treatment. These tests help physicians offer personalized treatment plans and enable more informed disease management strategy discussions with patients, without the need for more invasive and costlier tissue biopsies.”