ParagonDx receives 510(k) marketing clearance from the FDA for its warfarin sensitivity genotyping kit.

                                     ******  Read the press release here.  ****** 

--The effective application of personalized medicine.

ParagonDx is a leading provider of applied molecular diagnostic products. We were the first company to bring FDA-cleared Human Genomic Quality Controls to the market.  Building on pioneering work in pharmacogenomics (begun under the name Gentris Diagnostics Inc.), ParagonDx is applying decades of combined expertise and thought leadership to the development of innovative molecular diagnostic products. These products include reference controls for laboratory quality control, proficiency testing panels and molecular diagnostic reagents for pharmacogenomic testing. ParagonDx is currently developing diagnostic products for pharmacogenomic testing to aid in the administration of drugs being relabeled by the FDA, including warfarin and tamoxifen.
 
ParagonDx offers molecular diagnostic reagents including Analyte Specific Reagents (ASRs) produced in our GMP-compliant manufacturing facility. These products may be used by CLIA-approved laboratories in the development of laboratory developed tests.  Additionally, ParagonDx offers OEM and custom assay development services for in vitro diagnostic manufacturers who wish to outsource various stages of their diagnostic development needs.  Together, the products and services offered by ParagonDx will bring the promise of personalized medicine to physicians and patients. These diagnostic products can save lives and positively change the quality of health care for millions of people.