Products

Type 1 Diabetes Autoantibody Tests

THE PROBLEM:

Type 1 diabetes is an autoimmune disease that destroys insulin production by pancreatic islet cells, leading to a chronic and challenging-to-manage disease. With 40,000 new cases annually, type 1 diabetes affects more than 1.25 million Americans, with peak diagnosis in children between the ages of 2 and 17. Up to 40 percent of new cases are diagnosed with potentially life-threatening conditions such as diabetic ketoacidosis. Autoantibody markers appear well in advance of symptoms, and pilot studies have shown that screening for these markers can reduce the rates of often-deadly diabetic ketoacidosis at diagnosis, reduce medical complications and potentially improve patients’ quality of life.

THE SOLUTION:

  • Testing for type 1 diabetes autoantibodies helps determine risk of advancing to disease and eligibility for treatments that can delay the onset of disease.

  • Enable Biosciences’s ADAP assay for T1D is among the top performing assays in the world as presented at the Immunology of Diabetes Society (IDS) Congress.

  • Enable Biosciences has partnered with Hamilton Robotics to bring the improved assay to the Enable ADAP STAR platform, allowing for high-throughput population screening.

This product is available for Research and Clinical Diagnostics. We offer Clinical and Research Testing Services and Automated Workstations. Contact us at clinical@enablebiosciences.com.

QUICK FACTS

  • Type 1 diabetes is an autoimmune disease that affects 1-2 million Americans, mostly young children.

  • 40% of new cases are diagnosed with diabetic ketoacidosis, a potentially life-threatening condition. 

  • Autoantibody biomarkers appear years in advance of symptoms.

  • Testing for autoantibodies can reduce rates of medical complications and potentially improve quality of life.

  • Current tests are expensive, slow, or may miss critical diagnoses. 

REFERENCES:

  1. CDC National Diabetes Statistics Report, 2014.

  2. Diabetes Care 2017 Sep; 40(9): 1249-1255.

  3. Diabetes Care 2015 Jun; 38(6): 989-996.

  4. Diabetes Care 2003 Jan; 26(suppl 1): s33-s50.

 

Celiac Disease

THE PROBLEM

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Celiac disease (CD) is a gastrointestinal autoimmune disorder that affects millions of Americans. However, since many celiac patients do not present with gastrointestinal symptoms, diagnosis is often delayed or missed. A minimally-invasive test could identify at-risk patients and empower timely diagnosis by increasing testing compliance rates.

THE SOLUTION

Enable Biosciences’ ultrasensitive saliva assay is completely non-invasive. The saliva sample will be able to be collected in the convenience of your own home.

This product is RESEARCH USE ONLY. Contact us for more information at sales@enablebiosciences.com

QUICK FACTS

  • Celiac Disease (CD) is an autoimmune disease where the body attacks itself when gluten is ingested.

  • Celiac Disease can cause long lasting digestive problems and hinder your body’s intake of nutrients.

  • The average time-to-diagnosis of CD is between 3.5-11 years after first observed symptoms.

  • People with celiac disease have a 2x greater risk of developing coronary artery disease and a 4x greater risk of small bowel cancers. 

  • Untreated celiac disease can lead to the development of other autoimmune disorders.

  • While only 1% of the population of people are diagnosed with Celiac Disease, people with Type 1 Diabetes (T1D) have a 10-fold increased diagnosis risk.

 

Food Allergy

THE PROBLEM:

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Food allergy is a serious and growing health concern currently affecting 8% of children in the US. Blood tests based on the immunology marker IgE facilitate assessment of food allergy risks, and are required to recommend food avoidance or to implement new and innovative immunotherapies. However, current methods for allergy blood testing are expensive, require large volume phlebotomy and often result in false positives and negatives.

THE SOLUTION:

Enable Biosciences is developing an ultrasensitive assay based on the ISAP technology to detect the isotype specific antibody, IgE, for peanut, tree nuts, eggs, milk and shellfish allergens. The tests can detect multiple allergies from 1 microliter of serum while reducing the number of false positives and negatives.

This product is RESEARCH USE ONLY. Contact us for more information at sales@enablebiosciences.com

QUICK FACTS

  • Food allergies affect over 26 million Americans, which includes 3 million children. 

  • Every 3 minutes a person in the U.S. enters the emergency room for food-related allergic reactions (that’s over 200,000 people annually!).

  • Severe allergic reactions, anaphylaxis, need to be treated within minutes to avoid death. Spring-loaded injections of epinephrine (adrenaline) can be prescribed as a preventative measure for this reason.4

  • Common foods that people are allergic to include milk, eggs, peanuts, tree nuts, and shellfish.

  • Current tests detect food allergies include the skin prick test, oral food challenge or blood tests. 

  • Current tests can be inaccurate due to low assay specificity. 

  • Current tests that can detect specific allergy markers consume large amounts of resources and sample volumes, making it expensive and unaffordable to some.

 

Lyme Disease

THE PROBLEM

Lyme disease (LD) is caused by Borrelia burgdorferi, a diderm bacteria transmitted via regurgitated saliva of bites of infected ticks. It usually presents as flu-like syndrome, however the classical erythema migrans (EM) rash is often missed or unrecognized. If not treated definitively during early infection, patients can suffer severe and often irreversible consequences including facial palsy, polyarthritis, neuropathy and carditis. The prevalence of LD has increased exponentially over the past 40 years due to the inexorable spread of infected ticks across the US. More than 3 million Lyme tests are performed annually. Surprisingly, in contrast to other bacterial infections, direct detection of LD bacterium genomic materials and antigens are not particularly useful in early diagnosis. This is due to the extreme scarcity of LD bacteria in the circulation. The two-tier serological testing algorithm (first-tier enzyme immunoassay followed by a second-tier Western blot) is still the mainstay of Lyme testing. However, the two-tier algorithm identifies less than 40% of early infected LD, signaling an urgent and compelling need for better diagnostics for early detection of LD. 

THE SOLUTION:

Enable Biosciences has developed a highly sensitive and specific multiplex Lyme and tick-borne disease immunoassay. The enhanced sensitivity of the assay has the potential to improve diagnosis during the early stage of disease to permit effective treatment.

This product is RESEARCH USE ONLY. Contact us for more information at sales@enablebiosciences.com

OUR PARTNERS

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Tulane National Primate Research Center

QUICK FACTS

  • Lyme disease (LD) is caused by the bacterium Borrelia burgdorferi transmitted to humans through the bite of infected blacklegged ticks.

  • Typical symptoms include fever, headache, fatigue and a skin rash called erythema migrans, is often missed or unrecognized. 

  • If the infection is not recognized and treated properly during the early stages, patients can suffer severe and often irreversible consequences including facial palsy, polyarthritis, neuropathy and carditis. 

  • Over the past 40 years the prevalence of LD has increased dramatically, due to the inexorable spread of infected ticks across the US. 

  • More than 3 million Lyme tests are performed every year. 

  • Unfortunately, the Two-tier (first-tier enzyme immunoassay followed by a second-tier Western blot) serological testing algorithm is able to identify less than 40% of early infected LD.

REFERENCES

  1. Stanek G, Wormser GP, Gray J, Strle F. Lyme borreliosis. Lancet 379(9814):461-73 (2012).

  2. Hinckley AF, et. al. Lyme disease testing by large commercial laboratories in the United States. Clin Infect 59(5):676-81 (2014).

  3. Waddell LA, et. al. The accuracy of diagnostic tests for lyme disease in humans, a systematic review and meta-analysis of north American research. PLoS One. 11(12): e0168613 (2016).

  4. Tsai CT, et. al. Antibody detection by agglutination-PCR (ADAP) enables early diagnosis of HIV infection by oral fluid analysis. Proc Natl Acad Sci U S A. 115(6):1250-1255 (2018).

  5. Tsai CT, Robinson PV, Spencer CA, Bertozzi CR. Ultrasensitive antibody detection by agglutination-PCR (ADAP). ACS Cent Sci. 2(3):139-147 (2016).

 
 

Zika / Dengue

THE PROBLEM

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Zika virus (ZIKV) infection initially emerged as a global health concern in 2015. Since Zika and dengue (DENV) flaviviruses are found in the same geographic areas, accurate diagnosis to discriminate between the two infections is needed to optimize patient care. Fetuses of pregnant women infected by ZIKV are prone to manifest congenital Zika syndrome (CZS) including microcephaly, whereas DENV infected patients are at-risk for potentially deadly hemorrhage, circulatory and respiratory failure. Current assays fail to reliably differentiate ZIKV from DENV infection, especially in secondarily DENV infected populations. 

THE SOLUTION

Enable Biosciences developed a multiplex epitope profiling assay using variants of their ADAP assay to differentiate between ZIKV and DENV with high accuracy, sensitivity and ease of use. 

This product is RESEARCH USE ONLY. Contact us at sales@enablebiosciences.com

QUICK FACTS

  • Zika is a mosquito-borne viral disease that commonly occurs in warm climates.

  • Current diagnostic tests for the Zika virus (ZIKV) struggle to reliably differentiate between Zika and other flaviviruses.

  • Fetuses of pregnant women infected by ZIKV are prone to congenital ZIKV syndrome, which can cause birth defects such as microcephaly.

  • Prognosis and management of ZIKV and DENV differ greatly, despite both being similar flaviviruses.

  • Traditional nucleic acid diagnostic tests result in many false negatives.

  • Current “gold standard” diagnostic tests are potentially dangerous to perform and laborious.

REFERENCES

  1. Peterson LR., et al. “Zika Virus.” N Engl J Med. 374 (2016): 1552-1563.

  2. Bhatt S. et al. “The global distribution and burden of dengue.” Nature. 496 (2013): 504-7.

  3. Rabe IB., et al. “Interim guidance for interpretation of Zika virus antibody test results.” MMWR Morb Mortal Wkly Rep. 65 (2016): 543-546.

  4. Granger D., et al. “Serologic testing for Zika virus: comparison of three Zika virus IgM-screening-enzyme-linked immunosorbent assays and initial laboratory experiences.” J Clin Microbiol. 55(7) (2017): 2127-2136. 

 

Custom Assay Development

Antibody Detection by Agglutination-PCR can supercharge your immunoassay development process.

Contact us to find out how you can:

Reduce sample volume required per assay

  1. Detect ultralow levels of the target analyte

  2. Reduce costs per test

Enable Biosciences offers:

  • Assay Development Services

  • Automated Workstations with Hamilton Robotics

For more information about custom reagents, kits, and fully-automated platforms to meet your immunoassay needs, contact us at sales@enablebiosciences.com