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.
Research done by the Tulane University (New Orleans, LO, USA) supports the existence of persistent Lyme infections in rhesus monkeys. In this study, ten rhesus monkeys were infected with the Borrelia bacteria, which might cause Lyme disease. After 16 weeks, five out of the ten monkeys were treated with the recommended amount of doxycycline. This research shows that even after recommended doxycycline treatment, traces of the Borrelia bacteria could be found the monkeys’ tissue.
Borrelia bacteria still present after doxycycline treatment
One of the things the researchers discovered was that the doxycycline treatment could not wipe out the Borrelia bacteria completely. 7 to 10 months after the initial contamination, the researchers were still able to find traces of the bacteria, albeit in low numbers. What’s more, the researchers also showed that these bacteria were still viable.
The researchers concluded that the Borrelia bacteria could by-pass the immune system, that when treatment is started in a late stage of the infection, the bacteria can survive a doxycycline treatment and can damage vital organs. Because low numbers of the bacteria remain, it is possible that a persistent infection might be the cause of a lot of aspecific symptoms without an infection being detected. This research shows that it is crucial to start treatment as soon as possible, before the bacteria spreads throughout the body. This again emphasizes the necessity to discover a Lyme infection early.
Antibody response differs per individual
The researchers furthermore showed that the persistent presence of the Borrelia bacteria might not be reflected in the antibody production of an individual monkey. During the research, antibodies were measured on several different occasions. The antibodies of the monkey that were treated with antibiotics declined, but this was not always the case. However, some of the antibodies of the untreated monkeys also showed a decline. At Innatoss, we also see this individual variation in humans who have an EM or go through a seroconversion.
At Innatoss, we always say: “Mice are not men.” The upside is that this research was done on monkeys, which makes the translation to humans much surer as a study done on mice. Perhaps, this model can a be used to search in blood for biomarkers of an active infection that are relevant for humans.
Innatoss and MediSapiens have partnered to develop a novel Lyme borreliosis clinical interpretation and communication solution. The development is supported by the PERMIDES (Personalised Medicine Innovation through Digital Enterprise Solutions) project, funded by the European Union. Read more
Unfortunately, the validation of the Nanotrap Lyme Antigen test is not progressing as quickly as anticipated. The number of European samples we have received is too limited to validate the Nanotrap LA test. This means that Innatoss is not yet ready to provide the test results to the patients. Together with Ceres Nanosciences and clinical partners, we will remain working on the validation. Read more
In order to research the quality of our work, Innatoss participates in the so-called proficiency tests. At the end of September, we have tested three samples that were send by EUROIMMUN to 159 laboratories worldwide. Innatoss was the only Dutch participant of these 159 labs. On the samples, we have performed all six tests of our Lyme Complete test, and the results of these tests were submitted to EUROIMMUN. Read more
The Nanotrap® Lyme Antigen Test, a direct urine test for the presence of a Lyme bacteria protein, will be made available to patients throughout Europe.
MANASSAS, Va. —August 15th, 2017 — Ceres Nanosciences, Inc. (Ceres) and Innatoss Laboratories (Innatoss) announced today a partnership that will deliver the Nanotrap® Lyme Antigen Test out of Innatoss’ clinical testing laboratories in the Netherlands for patient benefit throughout the European Union. The Nanotrap® Lyme Antigen Test is the first highly-sensitive, urine-based test capable of directly detecting a Lyme protein antigen in a patient at any stage of infection. 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. To learn more about the Nanotrap® Lyme Antigen Test in the United States, visit https://www.lymedx.com/.