An update on the status of the availability of the Nanotrap® Lyme Antigen Test in the European Union
In August 2017, Ceres Nanosciences, Inc. (Ceres) and Innatoss Laboratories (Innatoss) announced the initiation of a partnership to assess and deliver the Nanotrap® Lyme Antigen Test to patients in the European Union. The Nanotrap® Lyme Antigen Test directly detects the presence of the outer surface protein A (OspA) from the Lyme disease causing organism Borrelia burgdorferi in the urine of infected patients. In 2015, Ceres launched the Nanotrap® Lyme Antigen Test for patients across the United States, after publishing the results of a 268-patient clinical study led by George Mason University in collaboration with leaders from the infectious disease community. Innatoss has been committed to replicating the patient-focused, data-driven clinical validation approach that Ceres pursued before it launched the test in North America. To that end, in the ensuing months, Innatoss has been collecting and analyzing European patient samples to evaluate the performance of the Nanotrap® Lyme Antigen Test in a European setting.
The early results from Innatoss have indicated that the OspA biomarker detected by the Nanotrap® Lyme Antigen Test is either not present or is present at undetectable levels in patients infected with the European strains of the pathogen that causes Lyme disease. Since the Nanotrap® Lyme Antigen Test was developed and optimized to detect Lyme disease in North American patients, additional development efforts are required to identify biomarkers that are better suited to detect Lyme disease in European infections. As such, the launch timeline for a European-specific Nanotrap® Lyme Antigen Test will be extended while the patient samples from Europe are evaluated to identify an appropriate biomarker. The hope is that this collaboration will ultimately lead to the development a European-specific version of the Nanotrap® Lyme Antigen Test.