CE mark

The test combines qPCR and microarray technology to detect carbapenemase-producing enterobacteriaceae, a bacteria resistance to carbapenem antibiotics.

The newly launched RT-PCR-based molecular diagnostic kits are designed for use in monitoring post-transplantation and immunosuppressed patients.

The assay is designed to quantitate HBV DNA in serum or plasma to assist in the treatment of chronic HBV-infected patients receiving antiviral therapy.

The firm’s test for detecting flu and differentiating between subtypes A and B is being launched in Europe, Asia, and South America.

By achieving certification for the assay, called PredictSure IBD, the Cambridge, UK-based firm can sell it for clinical use across Europe.

The firm's assay measures the concentration of the wild type and mutant alleles of hFE protein at three different mutation sites from a person's blood sample.

The firm said that the Resistance GC assay will allow doctors to treat up to 70 percent of infected patients with a single dose of ciprofloxacin.

The disease is an inherited form of muscular dystrophy characterized by a repeat expansion of 50 CTG trinucleotides or greater in the DMPK gene.

The company has also achieved a CE-IVD mark for its HemeAccuTest, which targets hematological malignancies.

The company and Women & Infants Hospital of Rhode Island are currently evaluating the technology to determine the performance of the test.