- The Food and Drug Administration on Friday approved Guardant Health's liquid biopsy for use identifying patients whose lung cancers have a mutation in a certain gene called EGFR. It's the first time liquid biopsy technology has been combined with next-generation sequencing in a single test, the agency said.
- Guardant's assay was cleared as a companion diagnostic for patients with EGFR mutations who might benefit from treatment with AstraZeneca's lung cancer drug Tagrisso.
- The approval came slightly earlier than expected, noted analysts at Cowen in a Sunday note to investors. Since Medicare already reimburses for next-generation sequencing in cancer testing, the impact of the agency's nod should help Guardant's position with private payers, they added.
Liquid biopsies, which are used detect cancer biomarkers in the blood, offer a faster, less invasive diagnostic alternative to tissue biopsies for analyzing tumor DNA. While they currently are useful mostly to guide treatment for late-stage cancers, the hope is they could eventually be applied more broadly for cancer detection.
Tim Stenzel, director of FDA's Office of In Vitro Diagnostics and Radiological Health, said the clearance "marks a new era for mutation testing."
"In addition to benefiting from less invasive testing, patients are provided with a simultaneous mapping of multiple biomarkers of genomic alterations, rather than one biomarker at a time, which can translate to decreased wait times for starting treatment and provide insight into possible resistance mechanisms," he added in a statement.
The FDA in 2018 granted Guardant's test a speedier review status that's reserved for technologies which help to address unmet clinical needs. Guardant said the test received FDA approval based on clinical and analytical validation data from more than 5,000 samples.
Progression-free survival rates among lung cancer patients who were identified for treatment with Tagrisso using the Guardant test were similar to those selected using traditional testing, data from two AstraZeneca studies showed, according to Guardant.
The test is also being studied as a companion diagnostic for medicines in development by other drugmakers, including Amgen, Johnson & Johnson and Radius Health.
Liquid biopsy testing has grown for Guardant, with the company reporting higher clinical volume during the second quarter, compared to the same period last year.
Guardant's test, called Guardant360, will be reimbursed under a national coverage policy set by the Centers for Medicare and Medicaid Services for genetic profiling using next-generation sequencing. Analysts at Cowen note this likely supports initial reimbursement for use of the test at around $3,500.
Guardant360 works by detecting circulating cell-free DNA from plasma of peripheral whole blood collected in Streck Cell-Free DNA Blood Collection Tubes, a product given De Novo authorization by the agency the same day as the Guardant360 approval.
Guardant is one of the major developers of liquid biopsy technology. But others are advancing in the field as well. In April, study results from Thrive Early Detection suggested the company's cancer blood test could detect tumors early on. But more work is needed to prove that hypothesis, which holds the promise of changing how certain cancers are found and treated.