Particles may be the answer to accurate Lyme disease detection
AUGUST 29, 2018 by RACHAEL KEENEY
Named a breakthrough device by the FDA, Ceres Nanosciences’ Nanotrap Lyme Antigen Test System offers a less invasive, more efficient way to test for the tick-borne disease.
Courtesy of Ceres Nanosciences
It all started in 2008 when Ross Dunlap, CEO of Manassas-based Ceres Nanosciences, decided he wanted to take a risk. Instead of continuing his work as a technology and management consultant, Dunlap wanted to switch gears to work for an organization with its own innovative product. Dunlap found that product, Nanotrap particles, through what he calls “serendipity and crossing paths at the right time.” His brother’s law firm put him in contact with George Mason University inventors funded by the National Institutes of Health to find a better way to detect various cancers, which led to the particles’ creation.
“It was understood when we were introduced to [the Nanotrap particles] that they had broad utility … basically in any kind of biofluid that could be processed with these particles we could look for markers of other diseases. We saw an opportunity … to do a lot of good, to really be a powerful tool for life sciences for patient benefit,” Dunlap explains of the decision to license the Nanotrap technology from GMU and create the particle manufacturing company in 2009.
Years later, Ceres published a 2015 clinical study citing how their technology could improve Lyme disease diagnosis by adding the particles to urine samples, a less invasive and potentially more accurate alternative to the serology (blood) test that is typically administered. In a blood sample, scientists look for biomarkers produced when an infected individual’s immune system responds to the tick-borne bacteria, a response that could take several weeks to develop and become detectable. As such, the current standard of care test has been known to result in false negatives.
“Our technology is novel in several ways in that we are detecting the disease itself, not your body’s immune response … [and] we are looking for the bacteria that the tick transfers into your system upon infection,” Dunlap says, explaining that the particles can either be present in a collection cup or be added into a sample later, where they then seek out and isolate the bacteria.
In 2016, through a clinical lab within GMU’s Center for Applied Proteomics and Molecular Medicine, Ceres began offering their Nanotrap Lyme Antigen Test System, which was named a Breakthrough Device by the Food and Drug Administration (FDA) this past July. With this endorsement, Ceres and the FDA maintain an open dialogue and are working to develop a clinical trial running through the 2019 tick season, early spring through summer. Depending on its results, an FDA-approved product could hit the market by the end of the year.
In the meantime, those believing they may have Lyme disease can approach their doctor about ordering a Nanotrap Lyme Antigen Test from Ceres’ website, with the option of taking the test at the doctor’s office or self-collecting at home and shipping the samples back to the lab. Because Lyme disease must be reported to state and federal health agencies, a prescription is required. // ceresnano.com