Nexsen is drawing up clinical plans for rapid development of Strep B tests

Nexsen’s StepSure clinical trial will be used to support its 510(k) filing with the US FDA. Image credits: fizkes / Shutterstock.

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 is working with Northern Health in Australia to conduct clinical trials of StrepSure, Nexsen CEO Tom Hanley said in an interview with Medical device network.

Hanley added that the trial will be conducted at Epic Hospital in Victoria, which is managed by Northern Health, and that the study will be conducted and paid for by Northern Health. The trial will compare StrepSure to the current standard of care for diagnosing GBS.

During the study, the 3,500 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) filing with the U.S. Food and Drug Administration (FDA). The company also plans to apply for approval in Australia, Canada, Japan, Brazil and the United Kingdom.

Hanley stated that Nexsen is working 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 received A$5.5 million (3.56 million) in grants from the Australian Federal Government and the Royal Melbourne Institute of Technology (RMIT University) in February to support the development of the StrepSure test.

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Current diagnostics to detect GBS include bacterial cultures, which provide results within one to three days. Nexsen’s point-of-care test is expected to deliver results within minutes.

GBS bacteria are commonly found in the rectum and vagina and affect two to four in 10 women, according to the UK’s 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 as a result of the Covid-19 pandemic. In January, Roche signed a $350 million deal to acquire LumiraDx’s point-of-care technology. The company’s portfolio of point-of-care tests includes a CE-marked HbA1c test.

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