from Modern Healthcare by Erica Teichert –
While many clinical trials fail because of bad results, nearly 1 in 5 fail because of low patient enrollment. In many cases, patients and their doctors don’t know they could be eligible to participate in a trial, which prevents promising treatments from reaching them.
Guardant Health, a 4-year-old company based in Redwood City, Calif., developed a liquid biopsy blood test that has helped match cancer patients with clinical trials and treatment options without costly or invasive biopsies. Instead, its Guardant360 test detects cancer DNA in a patient’s blood. CEO and co-founder Helmy Eltoukhy calls it’s a “game changer” for oncology.
“Many of these pharmaceutical companies would like to use a simple blood test rather than a biopsy as a companion diagnostic for their drugs,” Eltoukhy said. “It means many more patients will have access to the latest and greatest therapies.”
Studies have estimated as few as 3% of adult cancer patients are referred to clinical trials. Eltoukhy says that’s at least partially because only top medical centers generally have a team of specialists on-site to analyze biopsies. The Guardant360 blood test could be used to determine if stage 3 or 4 cancer patients have developed rare abnormalities that make them prime candidates for clinical trials.
Guardant believes blood tests will become a widely used alternative to traditional tissue biopsies and allow clinicians to more nimbly identify, monitor and treat cancerous tumors.
That promise has attracted $200 million in venture funding and the attention of many oncologists. Guardant has been marketing the technology since 2014 as a test developed in a CMS-certified laboratory and has started pursuing Food and Drug Administration approval through its pre-submission program. More than 20,000 patients have already been tested with it.
At MD Anderson Cancer Center in Houston, the Khalifa Institute for Personalized Cancer Therapy has used Guardant360 several hundred times in the past nine months to identify patients for clinical trials. The test has allowed Guardant to process results for patients who likely don’t have a large enough tumor or enough cancer DNA to be detected by the institute’s diagnostics and molecular tests.