SAN DIEGO, California – nanoComposix was recently awarded NIAID Phase II Small Business Innovation Research (SBIR) funding to develop a rapid, accurate, and inexpensive point of care (POC) diagnostic that incorporates the company’s gold nanoshells for improved sensitivity when testing individuals for cytomegalovirus (CMV), a herpesvirus that is among the leading causes of birth defects in the United States today. The team will partner with immunology experts at City of Hope to develop the diagnostic, which will yield results in a matter of minutes and demonstrate significantly greater sensitivity than existing technologies. These improvements will facilitate rapid, POC testing such that candidates can be screened for eligibility, their status determined within minutes, and immunization administered in a single visit to the clinic.
Vaccines are currently being developed for CMV, but improved diagnostics are essential to qualify candidates for enrollment in large scale clinical trials. One major problem with current diagnostics is their inability to detect the low antibody titers present in some infected individuals, leading to false negative readings prior to enrollment in vaccination trials. CMV has a low rate of seroconversion, such that only 0.5% of individuals infected with the virus will develop an immune response within a given year. As a result, the change in infection rate between a vaccine-protected population and an unprotected population may be very small. Thus, the diagnostics need to be very sensitive to ensure that clinicians can observe and accurately quantify those changes. Specifically, people who falsely appear not to have been infected with the virus and test positive at the end of the trial will obscure the efficacy of the vaccine. Clinical trials are conducted on large scales involving tens of thousands of individuals, so even small numbers of false readings will have a significant impact. Exquisitely sensitive testing methods are crucial.
This project focuses on the development of a lateral flow assay (LFA) to rapidly and accurately screen individuals for the presence or absence of IgG and IgM antibodies against CMV by placing a blood sample on a test trip outfitted with a simple visual signal readout, similar to the concept of a home pregnancy test. Integrating plasmonic gold nanoshells as the detector element provides ultra-high contrast to increase test sensitivity to overcome this obstacle. “Gold nanoshells demonstrate at least an order of magnitude greater sensitivity than standard lateral flow diagnostics,” said Dr. Richard Baldwin, VP of Research at nanoComposix. “This improvement will dramatically reduce the number of false readings that cloud the results of clinical trials all too often.”
Dr. Diamond, Chair and Professor in the Department of Experimental Therapeutics at the City of Hope – Beckman Research Institute, brings invaluable expertise to the team as a specialist in infectious pathogens, including herpesvirus strains such as HIV and CMV. According to the CDC, more than half of adults over age 40 have been infected with CMV and though there is no cure, healthy individuals often show no symptoms of infection. A major problem arises, however, when seropositive pregnant mothers unknowingly transmit the virus to their babies. Congenital CMV afflicts 0.64% of babies born in the United States today. Among those infected, approximately 20% will develop serious complications including hearing and vision loss, intellectual impairment, small head size, and other neurological disorders. For others with compromised immune systems, CMV can even be fatal. “Preventing pregnant women from contracting CMV will have an immediate and significant impact to reduce the number of newborn babies infected with CMV across the globe,” said Dr. Baldwin. “A rapid diagnostic and an effective vaccine for prevention are essential.”
nanoComposix is a world leading manufacturer of precisely engineered and highly characterized nanoparticles. Since 2004, they have been helping customers bring nanotechnology-enabled products to market. Their multidisciplinary technical teams provide rapid prototyping, characterization, integration, and scale-up solutions to accelerate R&D and commercialization for a wide variety of applications including biodiagnostics, topic therapeutics, nanomedicine, antimicrobial coatings, and color engineering.