Accurately Detecting Disease When it Matters Most

David Seftel, M.D.

Problem Tech Solves

Enable Biosciences, a multi award winning NIH/NSF/spin-off company out of UC Berkeley and a top-ranked graduate of the UCSF Entrepreneurship Program has developed, validated and deployed the world's first, independently-assessed best-performing, and the only dried blood spot compatible, multi SARs-Cov2 variant functional neutralizing antibody assay. The California Department of Public Health has just contracted with Enable Biosciences to utilize our neutralizing antibody test and our laboratory as the sole vendor for their landmark Statewide COVID-19 serosurveillance program funded by the CDC, called CalScope. They have added our neutralizing antibody assay to our current CalScope program support as the exclusive provider of home-dried-blood spot sample collected dual total antibody testing against both native wild type and vaccination. The Enable Biosciences multi COVID variant neutralizing assay was build on our unique patented ultrasensitive and highly specific DNA-barcoding antibody detection technology developed at UC Berkeley called Antibody Detection by Agglutination PCR or ADAP. ADAP is independently acknowledged in peer-review literature as the world's best platform technology for the accurate detection of challenging antibodies such as those associated with the causation of Type 1 diabetes. ADAP was ranked top worldwide in the blinded global Islet Cell Standardization Program (IASP) of the Immunology of Diabetes Society (IDS) run out of London and Munich. See paper for Clinical Chemistry attached. ADAP uses unique DNA barcodes conjugated to purified antigens of interest conferring both ultraspecificity while simultaneously unlocking the incredible amplification power of PCR for antibody detection (down to 10 to the negative 21 or zeptomolar levels).

Tech Brief

Eanble's assay is the only dried blood spot compatible assay for the quantitative measurement of neutralization capacity against multiple SARs-Cov2 variants of concern. ADAP was adapted into a true competition assay that gives a readout proportional to the measurable capacity of an individuals neutralizing antibodies (NAbs)to interrupt ACE-2 binding. Extensive head to head studies using blinded PRNT-assessed samples from the Mayo clinic were performed as part of a consortium on investigators from IUC Irvine, UC Davis, Vitalant Blood Banks, CDPH, the Swiss Red Cross in Basel Switzerland and Cerus Corporation.. The only other FDA approved PRNT-proxy assay for neutralization, made by Genscript, requires large volume phlebotomy, is not truly quantitative and is not automated and thus time and effort intensive. Enables multivariant neutralizing antibody assay is the only assay that is fully dried blot compatible without sacrificing sensitivity, specificity or functional performance. The assay is fully automated for high throughput precision function on a Enable-Hamilton Robotics liquid handling robotic analyzer that can be deployed in ant laboratory worldwide. Enable-Hamilton Robotics liquid handling robotic analyzers are currently installed in the CDPH central laboratory in Richmond California and Lund university in Sweden, with an Israeli installation in Tel Aviv about to be implemented. Reagents are low cost and the process is high throughput. Why is dried blood spot capability so important? Reaching and testing truly representative populations easily without sacrificing accuracy is critical to inform optimal publics health policies and practices. Enables assay is the only precision public and personal empowerment product.

Tech Differentiators

Public health is Enable's largest customer to date, with 4 CDC-funded contracts in place with expansion contracts for NAb assessment. Enable has longstanding collaborations, many of whom have become paying customers, with UC Campuses, Mayo Clinic, Harvard, Stanford, Columbia, University of Minnesota, Lund University, Royal Melbourne Hospital in Australia and others. Enable has B2C sales of assay services in 47 states via its web portal for Type 1 diabetes in collaboration with the Juvenile Diabetes Research fund, called T1Detect (www.) Enable will shortly be launching a B2C test ordering portal for SARs-Cov2 multivariant neutralization capacity testing for individuals in 47 states. Neutralizing assays have an appropriate billing code and CMS reimbursement rates of between $79.61 to $109 per variant depending on the State. Enable offers both a vertically integrated sample to answer service via analysis in its Federal and State CLIA-certified lab in South San Francisco or via setting up analyzers and systems for public health and other lab types under a facilitated LDT model, while its assay is progressing through the FDA for EUA.


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