Diatech Pharmacogenetics launches easyPGX, the ‘Ready to yoUSE’ CE-IVD Real-Time PCR line of products

Jesi (AN), Italy, 07/04/2017: Diatech Pharmacogenetics srl., the leading Italian molecular diagnostic company today announces the launch of the easyPGX®, the ‘Ready to yoUSE’ CE-IVD Real-Time PCR line of products and of Helix®, a kit for the extraction of circulating free DNA (cfDNA) from plasma.

The easyPGX® product line includes kits for the detection of KRAS, NRAS, BRAF, EGFR, involved in many solid tumors, of DPYD and UGT1A1 variants associated with toxicity upon Fluoropyrimidines and Irinotecan treatment respectively, and a Thyroid panel. Each mix allows the co-amplification of one or more mutated alleles plus an endogenous control gene. A specific oligo control mix enables the evaluation of the quality and quantity of DNA in each sample. Positive and negative controls are included to allow the monitoring of the experimental workflow.
The sensitivity of the assays is as low as 0.5% and the starting material can be DNA extracted from fresh, frozen, formalin-fixed, paraffin-embedded (FFPE) tissues and plasma, and genomic DNA (gDNA) from whole blood for DPYD and UGT1A1.

easyPGX® products are:

  • ready to use, reagents are delivered in 8-well strips pre-loaded with a complete master-mix in a dry, stable at room temperature format.
  • easy to use, no need for freezing, thawing and the low number of pipetting steps minimizes the risk of errors. Each assay strips are color-coded.
  • fast to use, the turnaround time, including deparaffinization and lysis is less than 3 hours with less than 10 minutes hands-on time.
  • safe to use, it is manufactured under ISO13485 and designed, developed and validated in accordance with the Directive 98/79/EC on in vitro diagnostic medical devices.

Helix®, circulating Nucleic Acid kit can be used from 1 to 5 ml of fresh or frozen plasma and the turnaround time is less than 3 hours.

For more info, please visit the product page.