Celadon GenoTyper™

Celadon GenoTyper is the world's first web-based multiplex analysis software for research and clinical genotyping. Easily configurable for any genotyping kit or platform, it implements a wide variety of features for allele and genotype calling, assay optimization, clinical interpretation and other data handling, with assay protocols derived from package inserts or researcher origination. Built out in full compliance with Good Laboratory, Clinical, and Manufacturing Practices related to FDA regulations (GLP/GCP/GMP) and with the 21 CFR Part 11 electronic records and signature rule, its implementation includes 11 SOPs and incorporates security features ranging from electronic signatures and audit trails to hierarchical role-based access privileging.

Applications: Diploid SNPs, Haploid SNPs, Sex Determination, Pathogen Identification, Personal Medicine, Companion Diagnostics, Multiplex

Initial Methods: Warfarin Dosage, Male Pattern Baldness

Future Methods: Real-Time qPCR, Copy Number Variation, Diagnostic Kits, Research Kits, Toxicity Exposure, MicroArrays

Key advantages of this pioneering software product include:

• It saves time and reduces laboratory errors by automating clinical interpretation for high-volume testing, In particular, it maintains data integrity by eliminating common sources of human error, tracks quality control samples and generates electronic reports automatically or on demand.
• Users can manage multiple assay runs as a project, and can search for individual samples.

In addition, since it was based on the Celadon Platform, Celadon GenoTyper is easily integrated into Laboratory Information Management Systems and is modularly structured for easy upgrade, such as for programming revised package insert formats or new genotyping analysis methods. This also means its current form is prepared for licensing or instantiation as an enterprise product, SaaS offering or solution support tool.

First Celadon GenoTyper Application: Powering Personalized Medicine for the CDC
In 2007, the U.S. Centers for Disease Control and Prevention contracted with Celadon, in partnership with Marligen (now Origene) to develop warfarin multiplex genotyping kits and automated analysis software. The web-based software that Celadon developed for CDC automates data transfer, from laboratory instrument to update of patient health record, and analysis of the results of a molecular diagnostic test kit for predicting safe and effective dosages of the drug Warfarin.

Warfarin is used to prevent blood clots that can cause heart attacks, strokes, and death. It is one of the most widely-prescribed drugs, with more than 30 million U.S. prescriptions annually, and a worldwide market of $10 billion. However, it is difficult to dose properly, and the consequences of an incorrect dose can be catastrophic. Variations in two genes account for as much as 50% of variation in warfarin dose among patients. With warfarin the second most frequent drug implicated in ER visits for adverse drug events, the FDA estimates healthcare cost savings of integrating gene testing into administering it could be $1 billion/yr.

Future Applications of Celadon GenoTyper in Depth

• Manufacturers of genetic analysis instruments can use GenoTyper to:
  • Improve customer experience by providing easy-to-use interface that is - consistent across product versions and product lines.
  • Reduce customer service costs via integration with technical support systems.
  • Broaden the utility and appeal of instruments by supporting more methods.
  • Attract and retain high-volume, high-profit customers by providing enterprise-class automation software.
• Vendors of genomic reagents can:
  • Enhance and complement broad range of genetic analysis products.
  • Develop catalog of pre-made assays.
• Point-of-care and other diagnostic device or assay developers can:
  • Provide single-interface that is pre-configured for each kit and analysis protocol.
  • Develop research and diagnostic assays faster, with less optimization and cost.
• Developers of pre-designed research assays can:
  • Expand capacity and increase productivity of assay development department.
• Large pharmaceutical, biotechnology, and other life science institutions can:
  • Improve consistency and quality control with application of a single interface for all kits, with direct connection from instrument to data management system.
  • Lower the cost of research and development by providing consistent, enterprise-wide analysis process and standards.
  • Integrate analysis with laboratory data management systems so as to increase productivity and reduce errors.
• Academic and industry researchers can:
  • Speed research; increase productivity; generate more consistent results; lower analysis costs; and better utilize student efforts.
• Diagnostic laboratories, genomic services and CRO organizations can:
  • Automate analysis and integrate it into electronic workflow.
  • Customize GenoTyper for preferred method and conditions.
  • Comply with FDA and CLIA regulations.
  • Lower costs and barriers, eliminate mistakes, and simplify processes by providing or enhancing online communication with customers.
  • Provide consistent, enterprise-wide analysis process and standards.
• Life science software vendors:
  • Create new sources of revenue with software subscriptions and enterprise licenses.
  • Provide customers with a more complete product offering.
  • Establish or increase web-based and Cloud informatics capability.
  • Integrate with and complement existing products.