NeuMoDx™ launches CE-IVD assays for HBV & HCV

NeuMoDx™ molecular, a sample-to-result molecular diagnostic company focused on central laboratory customers, announced the launch of CE-IVD assays for Hepatitis B virus (HBV) and Hepatitis C virus (HCV).

Hepatitis infections are more frequent in immunocompromised populations than in the general population with lower rates of spontaneous recovery in acute cases, thus resulting in increased morbidity and mortality in these patients. Quantitation of HBV DNA and HCV RNA titers in infected patients is essential to monitor disease progression and efficacy of antiviral therapies, as well as to aid in the management of patients with HCV or HBV infections In addition to focusing design and development efforts on tests to detect Sexually Transmitted and Infectious Diseases, NeuMoDx™ molecular offers solutions that integrate the entire molecular diagnostic process – from extraction to detection or ‘sample to result’ – with the first result available in approximately one hour. These innovative analyzers provide operators with the ability to load patient samples in a continuous, random-access workflow resulting in on-demand, high throughput sample processing with a true operator walkaway window of up to eight hours. “We are very pleased with our continued progress in expanding the menu on the first truly continuous random-access platform on the market” said Dan Harma, NeuMoDx™ Chief Commercial Officer. “Laboratories around the world will be able to deliver high quality results to clinicians and the patients they serve in a more rapid and efficient manner”.

The proprietary NeuDry™ reagents used with the systems require no refrigeration and are extremely robust with an on-board stability of up to 60 and ambient temperature shelf life of greater than one year. Furthermore, the unitized format of the NeuDry™ reagents significantly increases operating efficiency while minimizing the waste associated with systems requiring manual reconstitution and use of bulk format lyophilized reagents. In addition, NeuMoDx™ offers a broad range of general-purpose reagents and consumables for use by customers in developing qualitative and quantitative Laboratory Developed Tests (LDTs) for use with the NeuMoDx™ systems to detect and amplify DNA and RNA targets.