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Mobidiag Announces CE Mark Approval for CDI and 027 Ribotype Test

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Mobidiag Ltd has announced the launch of Amplidiag™ C. difficile+027, a qualitative qPCR-based test performed from DNA extracted from stool in suspected cases of C. difficile infection (CDI). The test is now CE-IVD marked and immediately available throughout Europe.

The test is both economical and well suited for high-volume screening purposes. It offers both accurate detection of pathogenic C. difficile by detection of tcdB (toxin B) gene, and highly accurate differentiation of the hypervirulence-associated 027 ribotype, in a single reaction.

The performance of Amplidiag™ C. difficile+027 was evaluated with 309 prospective and 35 spiked samples against toxigenic stool culture findings (the “gold standard”) and through independent molecular methods.

Amplidiag™ C. difficile+027 demonstrated 100% specificity for both tcdB and the 027 ribotype, and sensitivities of 97.8% and 94.4% for tcdB and the 027 ribotype, respectively. The 027 ribotype identification is based on two novel gene markers, whose combination produces a very high accuracy in identifying 027 ribotype from other ribotypes. The novel gene markers have been identified based on whole-genome sequencing of 88 C. difficile strains.

CDI and 027 major causes of mortality and increased healthcare costs
C. difficile is a major medical and infection control problem globally. It is a common cause of antibiotic-associated diarrhea and a major hospital-acquired infection. Increasing rates of incidence, mortality and hospitalizations related to CDI have been reported in recent years. CDI has been estimated to cause an attributable cost of over $7 000 per patient case and is associated with increased length of hospital stays. The hypervirulent 027 ribotype has been associated with more severe disease, hospital outbreaks, increased mortality rates and recurrent infections.

“CDI is a major cause of mortality and increased healthcare costs globally. Early identification is important for guiding patient management and infection control measures. It is important not only for patient outcome, but also in lowering the overall healthcare costs of CDI. That is why we are very excited to bring this new product to the market to meet high-volume screening needs”, says Tuomas Tenkanen, CEO of Mobidiag.

Mobidiag continues to expand its Amplidiag™ product line for gastrointestinal infections. The next product in the pipeline is intended to detect for Helicobacter pylori and related clarithromycin resistance directly from stool sample in a rapid, single-reaction qPCR test. The test will be the first of its kind and is estimated to bring substantial advantages to the diagnosis and primary eradication treatment outcomes of H. pylori infection.