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Created by BloodPAC members, the resource may serve as a set of generic analytical protocols to help define industry standards for developing liquid biopsy tests.
The company is using newly raised funds to support a disseminated trial model, which it said will help it keep its plans to finish the study by the end of 2021.
The agency approved the test for use across solid tumors and with multiple companion diagnostic indications including one for prostate cancer and three for lung cancer.
The company said proceeds will accelerate the ongoing FDA registrational study of its blood-based colorectal cancer screening test and further its extended pipeline.
The company has been authorized by the state of New Jersey to provide sequencing-based cancer detection and surveillance using patient-specific ctDNA assays.
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.
Researchers are developing a breath test to determine how severe patients' methylmalonic acidemia disease is, FierceBiotech reports.
NPR reports that vaccine developers are working on SARS-CoV-2 vaccines that are easier to store or administer than the current crop.
Reuters reports that France is to recommend that people under 55 who received one dose of AstraZeneca's SARS-CoV-2 vaccine receive a different vaccine for their second dose.
In Science this week: review discusses advances in liquid biopsies, and more.