Development and marketing of biotechnology products for Y-chromosome analysis


Sudhir K. Sinha and Jaiprakash G. Shewale. ReliaGene Technologies, Inc, 5525 Mounes St., Suite 101, New Orleans, LA 70123
Analysis of Y-chromosomes is useful for human identification in paternity involving male offspring or missing male offspring, evolutionary studies, and in forensic casework. In sexual assault cases it is possible to type the male DNA specifically. We have developed and commercialized two Y-chromosome genotyping systems, namely Y-PLEXTM6 and Y-PLEXTM5 which enable analysis of 11 loci on the human Y-chromosome. To market these systems activities were necessary for QA/QC protocols of critical raw materials, optimization of the analysis protocols, writing software for genotyping, validation of the developed systems as per the FBI’s DNA Advisory Board standards, acceptability in the courts, and promotion of the products in international markets The Y-PLEXTM6, introduced in January, 2001, and the Y-PLEXTM5, launched in July, 2002, are now supplied in 28 US states and 38 countries worldwide. Applications of these Y-PLEXTM products for forensic casework, paternity testing, and genealogy studies will be presented.