The new findings show the Percepta Nasal Swab, a first-of-its-kind genomic test, accurately classifies lung cancer risk in current or former smokers with lung nodules so that those with benign nodules may safely avoid unnecessary additional procedures.
This is the first approval to combine two technologies—NGS and liquid biopsy—in one diagnostic in order to guide treatment decisions.
A noninvasive urine test that can detect the presence of proteins linked to lung cancer could help detect more tumors in the early stages of the disease.
The new genomic test is Veracyte’s first commercial product since the company signed a strategic collaboration with Johnson & Johnson Innovation.
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Multigene panels would deliver greater value if patients with actionable genetic mutations consistently received guided treatments.
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Monitoring cancer therapy in real time enables physicians to make smarter treatment decisions.
Read MoreThe funds will be used to accelerate commercialization of Saga’s portfolio of kits and services, continue development of new products, and perform prospective clinical studies.
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The biomarker may provide a cost-effective and efficient means to identify elevated ROS1 protein expression in cancer.
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The designation’s accelerated regulatory review is intended to expedite use of the diagnostic in pharmaceutical trials.
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The draft LCD applies to advanced cancer patients who are covered by Medicare for next-generation sequencing of tumor tissue, but have insufficient or unavailable tissue samples.
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The tests will use patient breath samples to identify individual biomarkers that can predict a spectrum of diseases.
Read MoreThe companies’ collaboration underscores the need for proteomic data to enable precision medicine strategies for lung cancer patients.
Read MoreIf approved, the test could be the first FDA-approved multigene sequencing-based in vitro diagnostic to accept both plasma and FFPE-based inputs.
Read MoreThe assay enables researchers to measure tumor mutational burden and microsatellite instability, and detect other known and emerging biomarkers.
Read MoreDroplet digital PCR is rapidly becoming an invaluable tool in cancer treatment research.
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Liquid biopsy test identifies 70 of the most commonly mutated genes in solid tumors as well as microsatellite instability.
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New kit examines most relevant EGFR exons that affect therapeutic decisions for lung cancer patients.
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FDA approval allows use of the Therascreen EGFR RGQ PCR kit as a companion diagnostic for Pfizer’s Vizimpro (dacomitinib) in patients with non-small cell lung cancer.
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