ParagonDx (formerly Gentris Diagnostics)

Created by Brendan Doss.
Last Updated by Jessica Hegele.

Public Uncategorized

Tagged with biomedical technology, medical devices

Company Contact Information

Lee Richardson

Lee.Richardson@paragonDx.com

919.653.5520

Morrisville, N.C. 27560

www.ParagonDx.com

Michael Murphy, President & CEO

MPM casual.jpg

Meet The Company

Technology Overview and Industry Sector

ParagonDx, located in Morrisville, NC, is a leading provider of applied molecular diagnostic products. Initially a pioneer in the field of pharmacogenomics, ParagonDx has broadened its expertise into molecular diagnostic products. ParagonDx develops and markets reference controls for laboratory quality control and diagnostic kits that bring the promise of personalized medicine to physicians and patients. ParagonDx was the first company to bring FDA-cleared human genomic reference controls to the market. These products are intended to enhance patients safety, improve patients' response to therapy and help realize the promise of personalized medicine.

Management Team

Michael Murphy, President and CEO

Karen Nield, Vice President, Finance and Human Resources

Lee Richardson, Vice President, Business Development

Dean Watson, Executive Director, Product Operations

Deborah Kloos, Director, Quality Systems

Company Description

ParagonDx is leveraging its know-how to develop Human Genomic DNA Reference Controls (HGDRC)and diagnostic test kits that can be used to make pharmacogenomic profiling accessible to physicians and patients. After obtaining FDA clearance for six controls in 2006, our 2007 goals include pursuing clearance for the rest of our product line.

ParagonDx currently offers controls for cytochrome P450 polymorphisms (CYP2D6, CYP2C19 and CYP2C9), VKORC1, UGT1A1, NAT2 and MTHFR. Other relevant genes are under development.

ParagonDx controls are isolated from B-lymphoblastoids derived from individual donors. A proprietary prescreening process was used to identify potential sources for these reference controls from a group of properly consented subjects. All sequences have been verified by bi-directional sequencing. These controls can be used for assay validation, staff training and proficiency testing, and as a quality control in routine in vitro diagnostic testing. Each vial contains 10 µL at a concentration of 50 ng/µL.