REDMOND, Wash., Sept. 18, 2018 /PRNewswire/ -- The New York State Clinical Laboratory Evaluation Program (NY CLEP) has issued a laboratory permit and granted regulatory approval for Resolution Bioscience's ctDx Lung cancer assay. This next generation sequencing (NGS) test identifies actionable mutations in non-small cell lung cancer (NSCLC) from patient blood samples. Assay and laboratory approval were granted after a rigorous vetting process.
"This certification further validates our liquid biopsy technology and will help us operate more effectively in New York State," said Mark Li, Resolution Bioscience president and CEO. "We have a number of ongoing and planned clinical studies in New York, and this allows us to reach more patients."
The ctDx Lung assay gives clinicians a new tool to detect tumor mutations in individuals with NSCLC. The test can detect all four mutation types: single nucleotide variations, insertions and deletions, copy number variation, and gene fusions. This data will help guide treatment, determining patient eligibility for targeted therapies and clinical trials.
During standard biopsies, surgeons often have difficulty removing sufficient lung cancer tissue for both pathology and genomic testing. In contrast, ctDx Lung is non-invasive and requires only a single blood draw. Because blood can be rapidly drawn and analyzed, patients receive a thorough and timely genetic analysis. In addition, ctDx Lung gives physicians the ability to track lung tumors over time and determine whether they are responding to treatment or developing new mutations.
"We are beginning to see how blood-based cancer diagnostics can raise the bar for patient care," said Li. "We are also excited about our platform's ability to reveal varied and difficult-to-detect genomic alterations, and are applying those capabilities to support clinicians and develop companion diagnostics."
Founded in 2012, Resolution Bioscience is a privately-held and profitable NGS technology company.
About Resolution BioscienceResolution Bioscience, Inc. has created a proprietary platform to capture and analyze circulating, cell-free DNA. Through noninvasive diagnostic tools, the company seeks to improve care for cancer patients everywhere.
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"This certification further validates our liquid biopsy technology and will help us operate more effectively in New York State," said Mark Li, Resolution Bioscience president and CEO. "We have a number of ongoing and planned clinical studies in New York, and this allows us to reach more patients."
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The ctDx Lung assay gives clinicians a new tool to detect tumor mutations in individuals with NSCLC. The test can detect all four mutation types: single nucleotide variations, insertions and deletions, copy number variation, and gene fusions. This data will help guide treatment, determining patient eligibility for targeted therapies and clinical trials.
During standard biopsies, surgeons often have difficulty removing sufficient lung cancer tissue for both pathology and genomic testing. In contrast, ctDx Lung is non-invasive and requires only a single blood draw. Because blood can be rapidly drawn and analyzed, patients receive a thorough and timely genetic analysis. In addition, ctDx Lung gives physicians the ability to track lung tumors over time and determine whether they are responding to treatment or developing new mutations.
"We are beginning to see how blood-based cancer diagnostics can raise the bar for patient care," said Li. "We are also excited about our platform's ability to reveal varied and difficult-to-detect genomic alterations, and are applying those capabilities to support clinicians and develop companion diagnostics."
Founded in 2012, Resolution Bioscience is a privately-held and profitable NGS technology company.
About Resolution BioscienceResolution Bioscience, Inc. has created a proprietary platform to capture and analyze circulating, cell-free DNA. Through noninvasive diagnostic tools, the company seeks to improve care for cancer patients everywhere.
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SOURCE Resolution Bioscience
