CIO Bulletin

Enable Biosciences: Creating ultrasensitive analytical tools for precision medicine

Enable Biosciences, headquartered in South San Francisco, is a pioneering diagnostics company specializing in the development of ultrasensitive immunoassays. Their innovative technology enables the early detection and treatment of autoimmune and infectious diseases. By creating cutting-edge solutions, Enable Biosciences is dedicated to advancing healthcare and improving the lives of individuals affected by these conditions. Through their research and development efforts, they contribute significantly to the field of diagnostics, providing healthcare professionals with powerful tools to diagnose diseases accurately and initiate timely interventions.

Revolutionizing Healthcare: Enable Bioscience’s Impact on Treating Diverse Medical Conditions

Celiac Disease

Enable Biosciences addresses a crucial problem in healthcare concerning celiac disease, a prevalent gastrointestinal autoimmune disorder affecting millions of Americans. The challenge lies in the varied and often subtle symptoms, leading to delayed or missed diagnoses, especially when patients do not exhibit typical gastrointestinal issues. This delayed diagnosis can have significant consequences, impacting the overall health and well-being of affected individuals.

Enable Biosciences offers an innovative and practical solution to this problem. Their ultrasensitive saliva assay stands out as a groundbreaking diagnostic tool. Unlike conventional methods that require invasive procedures, this assay is non-invasive, allowing patients to collect saliva samples easily and comfortably within the familiar environment of their homes.

The convenience of at-home sample collection not only reduces the discomfort associated with medical tests but also significantly increases testing compliance rates. This is especially crucial for individuals who may be at risk for celiac disease but do not exhibit evident symptoms. By enabling these individuals to undergo a minimally-invasive test in the form of a saliva assay, Enable Biosciences empowers early detection.

Early diagnosis is pivotal in autoimmune disorders like celiac disease, as it enables timely intervention and appropriate treatment. By facilitating easy and non-invasive testing, Enable Biosciences' innovative approach ensures that individuals at risk can be identified promptly. This not only improves the accuracy of diagnoses but also empowers healthcare providers and patients alike to make informed decisions regarding treatment and lifestyle adjustments.

Food Allergy

Food allergy presents a significant and growing health concern, affecting 8% of children in the US. Currently, assessment of food allergy risks relies on blood tests utilizing the immunology marker IgE. These tests are essential for recommending food avoidance and implementing innovative immunotherapies. However, existing methods for allergy blood testing are costly, require substantial blood samples, and often yield inaccurate results, including both false positives and negatives.

Enable Biosciences is actively working on a groundbreaking solution. They are developing an ultrasensitive assay based on ISAP technology to detect the isotype-specific antibody, IgE, for major allergens such as peanuts, tree nuts, eggs, milk, and shellfish. Their innovative tests have the capability to identify multiple allergies from just 1 microliter of serum, significantly reducing the occurrence of false positives and negatives. This development not only enhances the accuracy of food allergy diagnosis but also holds the potential to revolutionize the way allergies are detected and managed, providing better outcomes for patients and caregivers.

Lyme Disease

Lyme disease, caused by Borrelia burgdorferi bacteria transmitted through tick bites, poses a significant health challenge. Despite its prevalence, early diagnosis is challenging due to the often-missed characteristic rash and the limited usefulness of direct detection methods in early stages. Untreated, Lyme disease can lead to severe consequences, including facial palsy, polyarthritis, neuropathy, and carditis. Current diagnostic methods, such as the two-tier serological testing algorithm, fall short, identifying less than 40% of early infections.

In response, Enable Biosciences has developed a cutting-edge solution. Their multiplex Lyme and tick-borne disease immunoassay is highly sensitive and specific, revolutionizing early disease detection. This advanced technology offers enhanced sensitivity, significantly improving the accuracy of diagnosis during the initial stages of the disease. By enabling more effective and timely treatment, Enable Biosciences' innovative immunoassay holds the potential to transform Lyme disease diagnosis and mitigate the severe consequences associated with delayed detection and intervention.

Type 1 Diabetes

Type 1 diabetes, an autoimmune disorder causing the destruction of insulin-producing pancreatic cells, poses significant challenges for management. Affecting over 1.25 million Americans, with 40,000 new cases annually, it is particularly prevalent among children aged 2 to 17, often leading to potentially life-threatening conditions like diabetic ketoacidosis (DKA). Early detection through autoantibody markers, appearing before symptoms, has shown promise in reducing DKA rates, medical complications, and enhancing patients' quality of life.

Enable Biosciences offers a compelling solution. Their ultrasensitive and cost-effective ADAP assay for Type 1 diabetes was recognized as one of the world's top-performing assays at the Immunology of Diabetes Society (IDS) Congress in 2018. Teaming up with Hamilton Robotics, they've enhanced the assay further, integrating it into the Enable ADAP STAR platform. This collaboration allows for high-throughput population screening, enabling efficient and widespread identification of at-risk individuals. By facilitating early detection, this innovative approach holds the potential to significantly reduce the incidence of DKA, improve patient outcomes, and contribute vital data to diabetes research, ultimately paving the way for a cure.

Zika/Dengue

The emergence of Zika virus (ZIKV) in 2015 raised global health concerns, particularly in regions where both Zika and dengue (DENV) flaviviruses are prevalent. Accurate diagnosis is crucial to distinguish between these infections and provide appropriate care. Pregnant women infected with ZIKV face the risk of congenital Zika syndrome (CZS) in their infants, leading to conditions like microcephaly. In contrast, DENV-infected patients are susceptible to life-threatening complications such as hemorrhage, circulatory, and respiratory failure. Existing assays struggle to reliably differentiate between ZIKV and DENV infections, especially in populations previously infected with DENV.

Enter Enable Biosciences, offering a groundbreaking solution. They have developed a multiplex epitope profiling assay based on their ADAP technology, tailored to differentiate between ZIKV and DENV infections with exceptional accuracy, sensitivity, and user-friendliness. This innovative approach holds immense promise in optimizing patient care, ensuring accurate diagnoses, and guiding appropriate treatments for individuals affected by these challenging viral infections.

Carolyn Bertozzi PhD | Co-Founder and Chair, SAB

Carolyn is a Professor of Chemistry at Stanford and an Investigator with the Howard Hughes Medical Institute. She has been recognized with many honors and awards for her research accomplishments. She is an elected member of the Institute of Medicine, the National Academy of Sciences, and American Academy of Arts and Sciences. She has been awarded the Lemelson-MIT Prize, the Heinrich Wieland Prize, and a MacArthur Foundation Fellowship, among many others. In addition to her academic position, Carolyn recently guided the creation and acquisition of a biotech startup, Redwood Biosciences. Professor Bertozzi was awarded the 2022 Nobel Prize in Chemistry.