Two blood tests are helping pulmonologists and oncologists determine therapy for patients with non-small lung cell lung cancer (NSCLC). The tests, which provide clinically relevant information within 72 hours, help guide treatment decisions in the management of the disease.
"This is novel - apart from getting answers quickly, the tests give patients a personalized view of the disease from a DNA and proteins perspective. No other company offers that," says Jasmine Gruia-Gray, PhD, vice president of marketing for Biodesix, a molecular diagnostics company and developer of the VeriStrat® and Genestrat™ tests. "These two tests together gives doctors a more comprehensive look at a patient's cancer and a more personalized look at a specific cancer," she adds. "Time to treatment is what enables physicians and patients to have deeper discussions as soon as they have a diagnosis."
VeriStrat uses the pattern of proteins in the patient's blood to help predict how the patient will respond to chemotherapy. GeneStrat is a targeted liquid biopsy mutation test for genotyping tumors of patients with NSCLC. This test also captures the EGFR mutation, which can be used to monitor the emergence of the primary resistance mutation in the EGFR gene.
About 30 percent of lung cancer patients either have insufficient biopsy tissue or are not candidates for a tumor mutation profiling. Even in cases where tissue biopsy is available, there is a sense of urgency to treat as soon as possible. The GeneStrat test allows patients to begin cancer treatment before receiving mutation results.
Karl Schroeder, MD, a pulmonologist at Cullman Primary Care Pulmonology, uses both tests along with tissue biopsy. "I draw blood for both tests before biopsy and know that I will receive the results within three days. When I get the result and the patient has cancer, I can go ahead and send the information to the medical oncologist and he or she will know how to treat within a week of diagnosis," Schroeder says. "The whole point of the tests is to expedite treatment, and we can get definitive testing in days instead of waiting almost a month."
Schroeder uses both the VeriStrat and GeneStrat tests. He says VeriStrat is particularly useful. "VeriStrat gives the prediction of whether or not a patient will respond well to chemotherapy," he says. "I think this test gives us the most specific information about late-stage cancers. While we still need to do more research, this definitely is a good test."
VeriStrat evaluates proteins in the blood to determine the aggressiveness of the cancer. If the level of the proteins is high, the result is a "VeriStrat poor" which means the patient typically does not respond well to chemotherapy and generally doesn't survive as long as patients with a "VeriStrat good" report. "We assume that a VeriStrat poor report means the cancer is a hyper-aggressive tumor and probably needs to be treated with experimental therapies instead of new immunotherapies if possible," Schroeder says.
He also uses the GeneStrat test, which he says has a good concordance rate with tissue. "The gold standard is to do the genetic gene sequencing on tissue, but we are able to do that now with this blood test and receive the results in 72 hours instead of waiting two and a half weeks," Schroeder says. "Having the answer quickly means we can go ahead and begin treatment for the EGFR-ALK mutation.
"These tests could eventually replace biopsies but that may be decades down the road. Right now, we are still at the point where we need to biopsy actual tissue."
The VeriStrat and GeneStrat tests are playing a primary role in a comprehensive lung program that Schroeder oversees in Cullman. "My goal is for this program to include a nodule clinic and other services and to deliver expedited care and treatment in 14 days," he says. "These tests are an integral part of expediting care, and they are helping me to provide state-of-the-art care to this population."
Schroeder believes these tests could eventually change how lung cancer is diagnosed and treated. "I use these tests on every patient I think may have cancer. The use of the blood tests is growing slowly in the field and more people are coming on board. I hope it will survive the test of time," he says. "More research is needed and we have to continue to validate the results. Biodesix is dedicated to doing that, and that is always good news."
Key words: non-small lung cell lung cancer; Biodesix; VeriStrat®; Genestrat™