Saturday, May 10, 2025
5/10/2025
Community Project Funding/Congressionally Directed Spending - Construction - The project goal is to create the Mason Center for Advanced Testing: Tick-Borne Disease Diagnostic Clinic to offer highly specific and sensitive diagnostic testing. Early diagnosis followed by antibiotic intervention can dramatically reduce the suffering caused by a tick-borne diseases. Virginia, like many parts of the United States, is suffering from an increased incidence of tick-borne illnesses, including particularly high numbers of cases reported and confirmed annually in Fauquier, Loudoun, Prince William, and Rappahannock counties. Mason scientists have developed a technology for patient sample self-collection that does not require refrigerated shipment and storage. One patient sample can be used to detect signatures derived directly from ALL the major known tick-borne pathogens. The technology is amenable to epidemiologic surveillance and screening of high-risk outdoor workers exposed to tick bites, and can also be used to directly analyze the tick itself. The George Mason University patented technologies and know-how has undergone scientific peer review and has been supported by NIH funding. The Mason test addresses the urgent unmet need to accurately diagnose and treat early-stage tick-borne infections before they progress to cause chronic suffering and disability, including cognitive impairment and cardiac failure. Samples (urine and tick) from patients who present to the clinic with a tick bite, will be collected by our medical clinic partners, and shipped to the university Lab where they will be analyzed. Results will be communicated to the requesting physician within 24 hours, enabling immediate initiation of appropriate therapy if positive for pathogens. Our test measures all the different tick-borne infections a patient can have, in one urine sample, using the highly sophisticated and accurate mass spectrometry. We are seeking an investment of $820,000 to be used for essential equipment. The requested funds will be used to launch the clinical deployment of a suite of unmatched Mason technologies for diagnostic testing of tick-borne diseases, such as Lyme disease, to the citizens of Virginia. The Mason Lab is CAP/CLIA certified for medical diagnostic testing (Liotta MD PhD, PI licensed Medical Director). Patient samples will be submitted through the treating physician, under an established IRB approved clinical research trial. The diagnostic report lists the specific amino acid sequences of the urinary peptides and the tick pathogen that the peptides are associated with. For our panel we will test 17 different tick-borne diseases at once. Our previous published clinical trial data demonstrates a sensitivity of >92% for early-stage Lyme disease in the first few days after a tick bite, with a specificity close to 100%. We are requesting the automation equipment to increase the throughput so we can perform many tests per day. Over the past two years we have achieved a 24-hour turnaround time for 250,000 COVID tests in the George Mason CAP CLIA certified laboratory, thus demonstrating our capability to conduct certified high throughput testing. The first year after we install the automation system supported under this award we will increase the testing speed by 10-fold. Based on the patient testing load we anticipate from 5 clinics in Virginia's 10th District, we expect that the samples are going to be approximately 400 per month per clinic. The automation equipment will be sufficient for us to meet these demands. The conventional serology test for Lyme disease, which is being recognized by the Virginia legislation to have low sensitivity and specificity, usually takes about 6-12 days from major diagnostic laboratories such as LabCorp and Quest. In contrast, our test turnaround time can be 24 hours.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).