SensiScreen

Primary DI

D-5713915SS010V4Q3

Basic UDI-DI Code

B-5713915SS010V4Q3

Reference

5585; 5586; 5587; 5590; 5591; 5592; 5600; 5601

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

PentaBase A/S

SensiScreen® Liquid PIK3CA qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for the detection, identification, and relative quantification of specific somatic mutations in the human phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) gene in cell-free DNA (cfDNA) purified from liquid biopsies including blood and plasma. The assay is used with real-time PCR systems and samples can be prepared using automated platforms or in manual workflows. The assay is an in vitro diagnostic medical device intended to aid in the detection, identification, monitoring of disease progression, and re-appearance based on PIK3CA mutation status. The test result correlates with the amount of PIK3CA mutant cfDNA. Result can be used to determine changes in PIK3CA mutation quantity levels in patients over time such as during cancer interventions and as an aid in selecting proper treatment of cancer. SensiScreen® Liquid PIK3CA qPCR Assay is intended to be used by healthcare professionals or qualified laboratory personnel instructed and trained in the techniques of real-time PCR as well as proficient in handling biological samples. Medical interventions based on results from this product requires medical authorization.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).