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Dx Focus: New Data on Curetis Unyvero Assays; DiaSorin Launches Toxoplasmosis Assay


Curetis said this week that it will present new clinical data on two new assays for its Unyvero molecular diagnostics system later this month at the Interscience Conference on Antimicrobial Agents and Chemotherapy in Denver and the Joint Annual Meeting of the German Society for Hygiene and Microbiology and the German Society for Infectious Diseases in Rostock, Germany.

First, Curetis will introduce clinical data from a pre-US Food and Drug Administration trial phase of the Unyvero LRT (lower respiratory tract) infection assay at the ICAAC conference. A poster will present data generated at Northwestern Memorial Hospital in Chicago during the initial familiarization and training phase for the FDA trial. The FDA trial is now being conducted at four sites, and all clinical data are blinded until it is completed in 2014, Curetis said. The LRT application is already marketed and branded outside the US as the Unyvero P50 pneumonia assay, which simultaneously analyzes 39 DNA targets related to pneumonia-causing agents.

In addition, Curetis will present data on its Unyvero i60 ITI assay at the annual DGHM/DGI meeting. The Unyvero i60 ITI assay is designed to diagnose implant and tissue infections by detecting pathogens and resistance markers. In a poster presentation, scientists will introduce the panel chosen to diagnose the eight indication areas, and will present initial validation and verification data with clinical samples, Curetis said. A second poster based on data independently generated at the University Hospital in Basel, Switzerland will compare the Unyvero Pneumonia P50 assay with standard culture and antimicrobial susceptibility testing.

"In fall this year, we will start a clinical CE evaluation study of the i60 ITI application, which we have been developing in close collaboration with our strategic development and commercialization partner Heraeus Medical," Curetis CEO Oliver Schacht said in a statement. "We are expecting the launch and marketing roll-out for early 2014."

Schacht added that Curetis has already started development efforts towards a third application, which it will update at upcoming investor meetings this fall.

The Unyvero Analyzer is an automated, cartridge-based, benchtop nucleic acid testing platform that combines a proprietary universal sample prep method with endpoint PCR and array-based detection.

The molecular division of Italian in vitro diagnostics firm DiaSorin has launched the Iam Toxo assay for the detection of Toxoplasma gondii.

The assay, which is CE-IVD validated for use outside of the US and Canada, is the latest addition to DiaSorin's Q-LAMP assay portfolio for the company's Liaison Iam molecular instrument, an easy-to-use benchtop molecular diagnostics device that performs quantitative loop-mediated isothermal amplification.

Iam Toxo is a duplex fluorescent Q-LAMP assay employing primers designed to recognize a multi-copy repeat region of the T. gondii genome that is common to all clinical relevant subtypes, DiaSorin said. The test can detect these subtypes in human plasma, cerebrospinal fluid, and amniotic fluid. The diagnostic sensitivity of the assay has been proven to be equivalent to PCR but delivers results in a fraction of the time that PCR requires, the company said.

The T. gondii parasite infects all mammal and bird species, but its primary host is the cat. Infection may be acquired via ingestion of material contaminated with feline feces, by the handling or consumption of infected undercooked meat, or via blood transfusion or organ transplantation. Infection causes toxoplasmosis with more than a third of the world’s human population estimated to be infected.

In healthy individuals, toxoplasmosis does not cause serious illness, but there are potentially severe or fatal consequences for immunocompromised patients.

While serological analysis is widely used for diagnosis of toxoplasmosis in immunocompetent individuals, molecular methods are necessary for diagnosis in immunocompromised patients, the company said.

In addition to being used for the primary detection of infection in immunocompromised patients, Iam Toxo is used as a secondary high-sensitivity confirmation after serological testing of toxoplasmosis infection in pregnant women and of congenital toxoplasmosis in infants.