The company was able to ramp up recruitment for its pivotal ECLIPSE trial after hurdles caused a falloff during the earlier months of the COVID-19 pandemic.
The assay provides comprehensive genomic information to oncologists from a blood draw, using targeted next-generation sequencing of circulating cell-free DNA.
Although its research test volume decreased significantly because of the COVID-19 pandemic, the company saw revenue growth across both clinical testing and development services.
Results from the Phase II INSPIRE study showed that change in ctDNA from baseline, as gauged by customized assays, predicted response to pembrolizumab.
The company is employing Guardant360 in a Phase III trial assessing the efficacy of the drug both in a larger population and in women who test positive for ESR1 mutations.
The collaborators will use SensID's controls with Saga's digital PCR-based Sagasafe technology, which can detect and quantify circulating tumor DNA in cancer patients at ultra-low allelic frequencies.
Analyzing both circulating tumor DNA and circulating tumor cells, investigators could classify patients into groups with significantly higher and lower recurrence risk.
Researchers concluded that there has been significant expansion of coverage for ctDNA assays over the past four years, but policies remain very heterogeneous and often limited.
The Washington Post writes that the approval in the US of a SARS-CoV-2 vaccine will be up to Peter Marks, a career official at the Food and Drug Administration.
