Nexsen Biotech plans to evaluate the sensitivity and specificity of its rapid point of care for Group B streptococci (GBS), StrepSure, in a clinical trial.
The Australian company has partnered with Northern Health in Australia to conduct clinical trials of StrepSure, said Nexsen’s CEO Thomas Hanley in an interview with Medical Device Network.
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Hanley added that the trial will be conducted at the Epic Hospital in Victoria, which Northern Health runs andthe study will be run by and paid for by Northern Health. The trial will compare StrepSure with the current standard of care for diagnosing GBS.
During the study, the 3500 participants will be sampled using StrepSure and the current standard of care at the same time. This performance, sensitivity and specificity, will inform the 510(k) application with the US Food and Drug Administration (FDA). The company also plans to file for approval in Australia, Canada, Japan, Brazil and the UK.
Hanley stated that Nexsen has partnered with Atomo Diagnostics to manufacture the first 10,000 units of StrepSure, which will be used as part of the clinical trial. However, the company plans to seek third-party manufacturing and plans to control marketing distribution internally.
Nexsen secured A$5.5m (3.56m) grants from the Australian Federal Government and The Royal Melbourne Institute of Technology (RMIT University) to support the development of the StrepSure test in February.
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By GlobalDataCurrent diagnostics to detect GBS include bacterial cultures, which deliver results in one to three days. Nexsen’s point-of-care test is expected to provide results within minutes.
GBS bacteria are commonly found in the rectum and vagina and affects two to four women out of ten, as per the UK National Health Service (NHS). It can cause serious infections in pregnant women, young babies, immunocompromised patients, and the elderly. The bacteria can be treated with antibiotics, but early detection is important to reduce complications.
The use and development of point of care diagnostics has increased following the Covid-19 pandemic. In January, Roche signed a $350m deal to acquire LumiraDx’s point of care technology. The company’s point of care tests portfolio includes a CE-marked HbA1c test.
