Luminex secures FDA and European approval for personalised medicine genotyping assay

24 September 2013 (Last Updated September 24th, 2013 18:30)

a US-based biotechnology company Luminex has received the US Food and Drug Adminstration and European approval for a comprehensive genotyping assay, xTAG CYP2C19 kit, an in vitro diagnostic test used as an aid to clinicians.

Luminex, a US-based biotechnology company, has received the US Food and Drug Adminstration and European approval for a comprehensive genotyping assay, xTAG CYP2C19 kit, an in vitro diagnostic test used as an aid to clinicians.

The kit will help clinicians in determining therapeutic strategy for therapeutics that are metabolised by the cytochrome P450 2C19 gene product.

Luminex's xTAG CYP2C19 Kit is an IVD assay that analyses a patient's CYP2C19 genotype from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples.

Cytochrome P450 2C19 (CYP2C19) is a clinically important gene that encodes a phase one drug metabolising enzyme responsible for metabolising a variety of prodrugs and drugs used to treat a number of conditions such as ulcers, seizures, malaria and anxiety.

The gene also plays a key role in metaboliwing drugs such as beta-blockers, anti-clotting agents and some antidepressants.

The xTAG CYP2C19 kit is indicated for use with the Luminex 100/200 or MAGPIX instruments.

"Our growing portfolio of pharmacogenetic assays include both FDA cleared and CE marked xTAG CYP2D6 and CYP2C19 assays demonstrating our commitment to offer testing laboratories regulatory cleared assays that are safe and effective for use as an aid in patient management decisions."

Luminex president and CEO Patrick J Balthrop said since cytochrome enzymes are responsible for metabolising over half of all drugs on the market today, it is important for a physician to have valuable information to determine whether a patient's specific genotype may impact their drug response.

"Our growing portfolio of pharmacogenetic assays include both FDA cleared and CE marked xTAG CYP2D6 and CYP2C19 assays demonstrating our commitment to offer testing laboratories regulatory cleared assays that are safe and effective for use as an aid in patient management decisions," Balthrop said.

Genetic variations in the CYP2C19 gene result in abnormal drug metabolism, which can lead to adverse drug reactions (ADRs) or suboptimal therapeutic response.

According to the estimation of FDA Adverse Events Reporting system (FAERS), there were nearly 800,000 ADRs in the US and Europe combined for the year 2011.

The incidence rate of serious and fatal ADRs is proportionate to the rising prescribed medication rate. Annually around $3.5bn is spent on additional medical cost associated with ADRs.