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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 recently had a second pre-submission with FDA and expects to begin a prospective trial of its test in the second half of this year.
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 firm will use the proceeds to advance its liquid biopsy early cancer detection assay CancerSEEK in an FDA registrational trial.
The recently renamed company will use the project to develop a new version of its next-generation sequencing assay for cancer mutational analysis.
The collaborators aim to develop lung cancer molecular diagnostic tests using molecular, clinical, and imaging-based artificial intelligence technologies.
The initiative will offer a liquid biopsy tool that only requires a blood draw for cancer treatment selection instead of a tissue biopsy.
Analyzing both circulating tumor DNA and circulating tumor cells, investigators could classify patients into groups with significantly higher and lower recurrence risk.
Four diagnostic firms have gone public so far this year, with three of the companies based in China but filing for US initial public offerings.
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 companies will work together to bring Guardant360 through regulatory approval and commercialize it as a CDx for Janssen's amivantamab.
The company recently presented results from its Aurora assay for multi-cancer screening and plans to launch a $100 test for the US and Chinese markets.
OncoCyte will cease further development of a liquid biopsy test that used an immune system interrogation approach to clarify whether patients’ lung nodules are benign.
Lexent's technology integrates low-pass whole-genome sequencing, fragmentomics, and DNA methylation to detect early stage disease.
The firm initially plans to apply the method, which measures the size of specific macrophages in blood, to predict lung cancer immunotherapy response.
The companies are developing a lung cancer liquid biopsy assay that will run on desktop sequencers, with plans to apply for regulatory clearance in China.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.
ArcherDX said the firms aim to apply minimal residual disease monitoring in clinical-trial protocols and for future therapy optimization.
In a proof-of-concept study, the group has demonstrated its platform could detect a biomarker of breast tumor metastasis and other disease biomarkers.
Lexent Bio's monitoring platform is in development and based on low-pass whole-genome sequencing and DNA methylation analysis.