Notice of Intent to Sole Source - Indigo Bioautomation

The CDC has a requirement for the support of Indigo ASCENT automated chromatography analysis and review software for the computational processing of laboratory data files that is only available through Indigo Bioautomation. ASCENT is a unique software program that use nonlinear fitting of exponentially modified Gaussian peaks to select peaks in chromatograms and determine the area under those peaks. Measuring the area under a peak is essential for measuring the amount of a substance in a sample using mass spectrometry. ASCENT speeds analysis of sam1Jles by automating peak selection and measurement of peak area. ASCENT also includes assay­specific quality assurance rules, which allow peaks to be automatically tested for quality. It is platform independent so it can be used on mass spectrometers from multiple different manufacturers. The configuration of the ASCENT product involves installation of a small computer program on the instrument laboratory computer that converts the data

analysis file to an open format which is then transferred to the vendor hosted data analysis service in order to perform quantitative analysis.ASCENT is a unique software program that use nonlinear fitting of exponentially modified Gaussian peaks to select peaks in chromatograms and determine the area under those peaks. Measuring the area under a peak is essential for measuring the amount of substances in the sample using mass spectrometry. ASCENT speeds analysis of samples by automating peak selection and peak area fitting. ASCENT also includes assay-specific quality assurance rules, which allow peaks to be automatically tested for quality. ASCENT is platform independent so it can be used on mass spectrometers from multiple different manufacturers. The configuration of the ASCENT product involves installation of a small computer program on the instrument laboratory computer that converts the data analysis file to an open format which is then transferred to the vendor hosted data analysis service in order to perform quantitative analysis. The unique features of ASCENT are: (1) Automated detection of peaks of interest (2) Automated integration (peak area determination) using peak fitting and integration of the peak lit equation (not trapezoidal summation techniques) and baseline algorithms able to measure area of peaks in high noise areas and peaks with other peaks overlapping their peak areas ( e.g., shoulder peaks). (3) Automated inclusion of assay-specific quality assurance rules to verify adequate quality or peak integrations and identification. (4) Platform independence so it works on mass spectrometers from multiple manufacturers, including Applied Biosystems. ThermoScientific, Waters, and Agilent. (5) Ability to handle peaks from both gas chromatography mass spectrometry (GC/MS, GC/MS/MS) systems as well as liquid chromatography mass spectrometry (LC/MS. LC/MS/MS) systems.