SOUTH SAN FRANCISCO, Calif.—Enable Biosciences has announced that the National Institute of Allergy & Infectious Diseases, part of the National Institutes of Health, has awarded the company a one-year Phase 1 Small Business Innovative Research (SBIR) grant for $225,000 in funding to enable development of an improved Lyme disease test.
The Centers for Disease Control and Prevention estimates that approximately 300,000 people will be infected with Lyme disease each year in the U.S. The current test identifies only 40% of early-stage cases, leaving many patients untreated and vulnerable to severe damage to the joints, heart and brain.
Enable Biosciences’ Antibody Detection by Agglutination-PCR (ADAP) technology is up to 10,000 times more sensitive than comparable tests, permitting earlier and more accurate detection of Lyme disease. The test will also better distinguish between Lyme and other tick-borne diseases, such as tick-borne relapsing fever and babesiosis, which require different treatment regimens.
“We are thrilled to be working on this collaborative project with two highly-acclaimed researchers, professors Monica Embers, Ph.D., of Tulane University, and Brynn Levy, M.Sc. (Med)., Ph.D., of Columbia University,” said David Seftel, M.D., MBA, Enable Biosciences’ CEO. “We anticipate that Enable’s tests will advance the treatment, clinical outcomes, and management of tick-borne diseases.”
Dr. Embers is a world-leading expert on Lyme disease and is affiliated with the Tulane National Primate Research Center, one of the first centers to develop a primate model of Lyme disease. She also serves on the scientific advisory board of the Bay Area Lyme Foundation. Dr. Levy is professor of Pathology and Cell Biology at Columbia University Vagelos College of Physicians and Surgeons, and medical director of Columbia’s Clinical Cytogenetics Laboratory. He will contribute archived serum samples and oversee clinical validation for the project. Columbia and Tulane are both sub-awardees of the grant.
“We will automate this test in a Phase 2 project so that earlier and more accurate diagnosis will be widely available,” noted Jesse Cortez, Ph.D., Automation Lead for Enable Biosciences.
In June Enable Biosciences also announced a collaboration with Hamilton Company, the purpose of which is to provide fully automated processing of up to 96 liquid biopsy samples at one time, using a novel ultra-sensitive, highly specific immunoassay in a hands-free workflow. The immunoassay, currently available for research applications in Type 1 diabetes, Lyme disease, allergy and HIV testing, is intended to support development of early stage treatment interventions to improve patient health and quality of life with reduced disease-related complications.
“Hamilton’s STAR platform has proven to be a perfect fit for Enable’s multi-award winning assay chemistry developed with the support of the National Institutes of Health and the National Science Foundation and extensively validated with the leading diabetes institutes, our Ivy League academic partners and others,” explained Seftel in a press release. “Researchers around the world now have a best-in-class early and accurate antibody detection solution, with clinical testing services to be available shortly on the Hamilton machines at our soon-to-be certified CLIA reference laboratory in South San Francisco.”
The qPCR-based assay technology developed by Enable Biosciences, known as ADAP, uses synthetic antigen-DNA conjugates to detect the presence of antibodies in liquid biopsy samples with 1,000 - 10,000-fold greater analytical sensitivity, compared to other single and multiplex assay technologies. As the assay uses very small sample volumes of approximately one microliter, sample collection processes may be less disruptive for patients, and a two-step verification process resists potentially interfering contaminants in the body fluid sample.
Hamilton’s Microlab STAR automated workstation is available pre-configured and qualified to work with the Type 1 diabetes ADAP assay, with the additional chemistry workflows to follow shortly. By automating the ADAP assay workflows on the Microlab STAR, sample throughput is significantly increased and active labor time, along with risks of error and variability, is virtually eliminated compared to manual methods. User-friendly software guides operators of any skill level through assay setup and processing, while automated barcode verification ensures sample tracking and proper reagent and consumable placement. When used with Hamilton’s wide range of pipette tips, patented Compressed O-Ring Expansion (CO-RE) technology creates a tight seal to support highly accurate and consistent results.
The Microlab STAR optimized for the ADAP assay technology will be co-promoted by Hamilton and Enable Biosciences. A single, localized point of contact will enable researchers to seamlessly integrate the automated workflow into their laboratory, while leveraging the respective expertise and services of each company.
“We’re honored to collaborate with Enable Biosciences on this market-changing solution,” added Dr. Michael Mouradian, director of Robotics at Hamilton. “By uniting our respective strengths, researchers and clinicians can be confident in rapid, robust results that can improve patient outcomes.”
