Analytical validation of the LungLB test: a 4-color fluorescence in-situ hybridization assay for the evaluation of indeterminate pulmonary nodules.

Background: Evaluation of indeterminate pulmonary nodules (IPNs) often creates a diagnostic conundrum which may delay the early detection of lung cancer. Rare circulating genetically abnormal cells (CGAC) have previously demonstrated utility as a biomarker for discriminating benign from malignant small IPNs in the LungLB assay. CGAC are identified using a unique 4-color fluorescence in-situ hybridization (FISH) assay and are thought to reflect early cell-based events in lung cancer pathogenesis and the anti-tumor immune response.

Independent evaluation of a DNA microarray system for Salmonella detection in ground beef.

A new DNA microarray test kit has been developed to detect foodborne pathogens in various food matrices. This study focuses on evaluating the PathogenDx microarray-based system to detect Salmonella in ground beef and verify critical parameters that could interfere with the method's effectiveness, such as enrichment incubation time, ground beef fat content, inclusivity, exclusivity, and analytical sensitivity. Sample preparation protocols were evaluated at 6, 8, 12, 18, and 24 h enrichment times at varying bacterial levels to identify optimal conditions to detect the invA gene using the PathogenDx microarray.

The presence of circulating genetically abnormal cells in blood predicts risk of lung cancer in individuals with indeterminate pulmonary nodules.

Purpose: Computed tomography is the standard method by which pulmonary nodules are detected. Greater than 40% of pulmonary biopsies are not lung cancer and therefore not necessary, suggesting that improved diagnostic tools are needed. The LungLB™ blood test was developed to aid the clinical assessment of indeterminate nodules suspicious for lung cancer.

PathogenDx DetectX Combined Demonstrates Equivalent Performance in Comparison to Four AOAC Certified Methods for the Detection of Aspergillus Species, Salmonella Species, and STEC in Dried Hemp Flower.

Background: The PathogenDx DetectX Combined method is a certified Performance Tested MethodSM (012201) that is enrichment-free and utilizes a DNA microarray-based end point PCR method for the simultaneous detection of Aspergillus (A. flavus, A. fumigatus, A.

Rapid detection of Salmonella enterica in leafy greens by a novel DNA microarray-based PathogenDx system.

The diverse matrices pose great challenges for rapid detection of low Salmonella level (<10 CFU) in fresh produce. The applicability of microarray-based PathogenDx system for detecting low contamination of Salmonella Newport from leafy greens was evaluated. A pre-PCR preparation protocol including enrichment in universal pre-enrichment broth for 3 h followed by sample concentration using an InnovaPrep bio-concentrator or 6 h enrichment without a concentration step was used for detecting S.