NEW YORK ─ Diagnostic firm Veravas is looking to apply its sample prep technology to the development of more sensitive and accessible tests for a variety of diseases.
The company, which recently launched a new biomarker enrichment tool called VeraBind, is pursuing internal test development efforts in areas including Alzheimer's as well as targeting outside diagnostic developers and pharma firms as customers for its products.
Founded in 2017, Austin, Texas-based Veravas has to date focused largely on selling sample preparation kits for identifying and eliminating common sources of assay interference. The VeraBind product combines this interference elimination with affinity capture of target analytes to enable more sensitive biomarker detection, said Veravas CSO Joshua Soldo.
In the first step of the VeraBind sample prep process, the company's magnetic bead-based VeraBind Clean reagent is used to remove potentially interfering agents like biotin, rheumatoid factor, and anti-histidine and anti-PEG antibodies. Following removal of VeraBind Clean beads, the sample is treated with a set of beads functionalized with capture agents targeting the analyte of interest. After capture, the sample matrix is discarded, which Soldo noted, removes remaining potential interferences. The target biomarkers are then eluted off the capture beads into a buffer, producing a matrix-free sample for analysis.
According to the company, the approach is compatible with a range of common clinical assay types including ELISA, chemiluminescence, and mass spectrometry.
Soldo said Veravas expects VeraBind will open up a variety of opportunities for diagnostics developers. A main one will be the ability to more easily use sample types that currently have poor compatibility with existing clinical analyzers. The company is particularly interested in saliva-based tests, which Soldo said have been hindered by the fact that "saliva can be a nonconducive sample for existing analyzers due to viscosity and other issues."
He suggested that using VeraBind to isolate target biomarkers in saliva and then purify them into a matrix-free sample will make such analyses more straightforward.
"We transform what started off as a saliva-based sample into a matrix-free sample," he said. "When you eliminate the sample matrix, you remove a variety of interfering substances, and the detection and quantitation of one or more biomarkers becomes a standardized process, and that translates into very good reproducibility with high sensitivity and specificity."
Additionally, Soldo said, by removing interferences, the process makes it more feasible to use large starting sample volumes, which can boost assay sensitivity.
Veravas plans to develop proprietary diagnostics using its technology with an initial focus on Alzheimer's disease. It is developing assays to eight different biomarkers linked to Alzheimer's: amyloid-beta 40 and 42, phosphorylated-tau 181, 217, and 231, glial fibrillary acidic protein, neurofilament light chain, and alpha-synuclein.
Soldo said the company aims to develop a workflow using the VeraBind technology that will purify all eight markers in a single reaction for subsequent detection.
For detection, Veravas plans to use an immunoassay approach called proximity-based homogeneous bioluminescence. The method uses pairs of antibodies to a given target. When both antibodies bind to the target, they are drawn into proximity with each other, which then allows them to bind to a third protein that generates a bioluminescent signal. Soldo said the approach can deliver femtomolar sensitivity with extremely high specificity.
Veravas is working on two Alzheimer's assays using its technology — a diagnostic test in plasma and a risk-based screening assay in saliva. Soldo said the company aims to develop both tests and begin the US Food and Drug Administration regulatory process in the next two years. The company has sourced antibodies to the markers in its Alzheimer's panel from diagnostics firm Fujirebio, which is also active in Alzheimer's test development.
Soldo said the company sees risk-based screening for Alzheimer's using saliva samples as a particularly promising application.
"We think that is the biggest untapped market," he said.
While many researchers and companies in the Alzheimer's testing space are pursuing plasma-based testing as a more accessible and less expensive alternative to more established approaches like cerebrospinal fluid testing and PET imaging, Soldo suggested that a saliva-based test could be even more accessible, potentially allowing for users to collect their own samples and mail them in for testing.
Nearer term, Veravas plans to release research-use-only VeraBind purification kits for amyloid-beta 40 and 42 and phosphorylated-tau 181. Soldo said it hopes to launch these kits at the American Association for Clinical Chemistry annual meeting at the end of July.
Veravas ventured into the diagnostics space during the COVID-19 pandemic, using its sample prep technology for a saliva-based antibody test and a saliva-based antigen test. The company received $452,244 in funding from the National Institutes of Health RADx program for development of the antigen test.
Soldo said that while it successfully developed the antibody test, the FDA declined to review the company's Emergency Use Authorization request, and so it was not able to bring the assay to market. He said the agency told the company that the needed antibody testing capacity had been met at that time and so its EUA submission was not a priority.
Regarding the antigen test, Soldo said the company decided it was going to take too long to commercialize and so chose to prioritize development of VeraBind instead.
In addition to using VeraBind for its internal test development, Veravas plans to sell the technology to customers in the diagnostics or pharma industries where Soldo suggested it could help with the development of new assays, particularly in less commonly used sample types like saliva, or improving the performance of existing assays.
"Someone like Roche might be interested in using our technology to further improve the sensitivity of, say, a plasma test," Soldo said.
He said that thus far the company has provided the VeraBind Clean portion of the larger VeraBind kit to a number of in vitro diagnostic companies for evaluation. By and large, these companies are not looking to incorporate the VeraBind Clean kit into their assays but are, rather, using the product to identify potential interferences when optimizing assays during the research and development process.
"No one wants to have to just clean every sample," Soldo said. "They would rather develop better assays through assay design. That's what assay developers do. They try to design the most robust, accurate assays that they can and to increase the thresholds for interferences as high as they can. Our technology is a way to help them do that."
Soldo said, however, that Veravas expects that diagnostic developers may want to incorporate the full VeraBind workflow — meaning both the cleaning and capture steps — into their clinical assays. He said the company plans to meet at the upcoming AACC meeting with IVD companies as well as reference laboratories and hospital labs to explore their interest in using VeraBind for development of IVDs and laboratory-developed tests.
Veravas has raised $15 million in funding to date. The company plans to raise an additional $4 million in funding through a Regulation D offering, with those funds largely supporting development of its Alzheimer's tests.