Palmetto GBA has issued a draft local coverage determination for the company's Xpresys Lung 2 lung cancer test, an update version of its original Xpresys test.
The Medicare contractor is proposing to not cover Vectra DA, but to extend coverage for Prolaris, Xpresys, and DecisionDx-UM under specific circumstances.
The study found that with use of the mass spec-based test, about a third of surgeries and total invasive procedures, including biopsies, could be avoided.
The study suggests Indi's Xpresys test could be useful in physician decision making but raises questions about the extent to which doctors will follow its recommendations.
Company researchers showed that the agents could selectively target single point mutations not associated with protein-binding pockets.
Many of the meeting's proteomics presentations concerned not so much mass spec analysis itself as the refinement of processes and workflows leading up to it.
The MRM-MS-based method combines use of conventional stable isotope-labeled peptide standards with a series of endogenous protein standards.
The company hopes to launch the test sometime this year after completing CLIA certification of its clinical laboratory and securing reimbursement.
The agreement gives Caprion, which did significant development work on the test, exclusive rights to market and commercialize Xpresys Lung inCanada.
The 141-sample study found the test could identify benign lesions in lung cancer patients with a negative predictive value of between 84 percent and 98 percent.
In Nucleic Acids Research this week: nanopore sequencing workflow to detect antibiotic resistance in gut microbes, TSSPlant tool, and more.
Because gene-edited organisms can cross borders, Gizmodo wonders whether there should be an international body to govern their use.
HHS Secretary nominee Tom Price is to go in front of the Senate Committee on Health, Education, Labor and Pensions today, NPR's Morning Edition reports.
Prior to being closed, Theranos' Arizona lab failed an inspection by regulators, according to the Wall Street Journal.