GHP September 2015
ghp September 2015 | 53 The MiniLab platform and Influenza A/B RSV Panel are CE marked in compliance with IVD directive 98/79/EC. The company’s first syndromic panel is for detecting respiratory viral pathogens, especially since respiratory infections have a high morbidity and mortality rate and patients present with similar clinical symptoms making it difficult for clinicians to determine the causative pathogen(s). Despite respiratory infections causing high morbidity and mor- tality for all age groups, very young pediatric patients and patients with comorbidity factors have higher mortality rates. The MiniLab enables clinicians to test patients presenting in the emergency department to quickly determine optimal treatment, send the patient home or admit the patient. In a few months, Enigma Diagnostics plans to launch a more comprehensive respiratory panel that includes Influenza A, Influenza B, RSV and Rhinovirus. Currently, the company is developing a range of high value yet cost-effective syndromic panels targeting the large and high growth area of infectious diseases for critical care patients. The list of syndromic panels includes a Respiratory Viral Panel, Respiratory Bac- terial Panel, Bacterial and Viral Meningitis, Carbap- enemase Producing Organisms, Multi Drug Resistant Tuberculosis, Pneumonia, Sepsis directly from blood and others. The plans are for several panels to be launched each year. The benefits of using syndromic panels measured in clinical evaluations, includes improved outcomes and increased satisfaction for clinical staff, as well as pa- tients and their family. Enigma Diagnostics is working with key opinion leaders to identify needed syndromic panels, as well as clinically evaluate them. Enigma Diagnostics was founded in 2004 to develop and commercialize technology and intellectual property from the United Kingdom Government’s Defence Science and Technology Laboratory (Dstl). Leveraging its extensive range of proprietary technolo- gies and intellectual property, the company developed the MiniLab combining the speed and sensitivity of PCR with the simplicity needed for clinicians to use it without changing their workflow. The MiniLab benefits from global manufacturing and supply chain providing scalability and an attractive cost base enabling Enigma Diagnostics to forge a solid leadership position in developed and emerging molecular diagnostic health care markets. As molecular diagnostic testing is replacing conven- tional methodologies for the diagnosis of infectious diseases and syndromic panels are replacing serial pathogen detection testing, Enigma Diagnostics is now pioneering the use of molecular diagnostic syndromic panels in the POC to empower clinicians with the high value comprehensive molecular diagnostic results that they need on demand to quickly initiate targeted treat- ments. The new paradigm of using molecular diag- nostic syndromic panel testing in the POC will quickly increase with the advent of easy-to-use cost-effective platforms, such as the MiniLab. The MiniLab provides physicians with the much needed decentralized solution for accessing quick comprehensive results for patients, especially critical care patients, whose clinical presentation make it difficult to determine the causative pathogen. Note: MiniLab Products are CE-IVDmarked not FDA cleared. Jessica Barrett is Commercial Director from Enigma Diagnostics Limited. health and social care
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