Industry Information

Immunoassays

Immunoassays detect a number of medical conditions and have an increasingly significant role in medical testing and diagnostics.

What Are Immunoassays?

An immunoassay is a laboratory test method for detecting a substance by using an antibody reactive with that substance. Antigens are invaders, toxins or other foreign substances (such as chemicals, bacteria, viruses, or pollen), that sneak into our bodies and can possibly cause us harm; however, they trigger our immune system, which fights them off. Our immune systems, triggered by the antigens, produce antibodies – “hero” particles sent to fight off the invaders. Our bodies produce different kinds of heroes – antibodies – to fight off specific enemies – antigens. Because our bodies produce antibodies only as a reaction to the presence of antigens, we can determine the presence of a harmful substance (the antigen) by testing for the presence of its counterpart (the antibody), and vice versa. This kind of laboratory test method is called an immunoassay. Immunoassays detect a number of medical conditions and have an increasingly significant role in medical testing and diagnostics. For example, the detection and diagnosis of the Zika virus is performed by the immunoassay test method. Immunoassays test for the presence of either an antigen or an antibody.

Testing for Antibodies

Examples of immunoassay tests for antibodies include tests for the presence of autoimmune antibodies seen in patients with rheumatoid arthritis), West Nile Virus (which tests for antibodies made in response to that virus) or antibodies made in response to a vaccination (such as tests for Hepatitis B antibodies to ensure the vaccination’s success).

Testing for Antigens

By containing antibodies specific to an antigen of interest, immunoassays test blood or other fluid samples for the presence of antigens. The antigen’s reaction within the sample to the specific antibody can then be compared to reactions of known concentrations, determining the amount of antigen present. Examples of immunoassay tests for antigens include drug levels (like digoxin, vancomycin), hormone levels (like insulin, TSH, estrogen), and cancer markers (like PSA, CA-125, and AFP).

Immunoassay Market Outlook

Immunoassays have an increasingly significant role in medical testing and diagnostics. This trend is reflected in the projected global market size and reach over the next ten years and beyond.

$17.16B in 2016

$28.3B by 2022

$36.1B by 2025

Immunoassay testing provides overall higher diagnostic specificities and sensitivities when compared to other testing methods. Additionally, the short turnaround time and high sample throughput have propelled immunoassays to the forefront of innovative testing technologies and improved diagnosis quality. Several key factors contribute to the expanding global reach of the immunoassays market.

 

  • Growing preference for non-invasive diagnostics
  • Rising prevalence of chronic and infectious diseases
  • Improved access to healthcare and testing in developing regions
  • Innovative technologies and improved diagnosis quality
  • Sensitivity, cost-effectiveness, and rapidity of immunoassays
  • Increased life expectancy and rapidly aging population.

 

The immunoassays market has a projected global market of USD$28.3 billion by 2022 and USD$36.1 billion by 2025. While the U.S. currently has a dominant share of the market at about 35%, Asia-Pacific is leading growth with a projected compounded annual growth rate (CAGR) of about 10.6%. The global immunoassays market is projected to grow globally at the CAGR of about 8.4% through 2025. Nano Discovery’s products for monitoring immune system function and activity will provide cost-effective, critical information to develop targeted solutions for the prevention, management, and control of infectious diseases.

Global Impact

The D2Dx™ platform has the potential to disrupt the detection and diagnosis of infectious diseases. D2Dx boasts high-sensitivity immunoassay diagnostic testing, unmatched by current diagnostic techniques. The enzyme-linked immuno-absorbent assay, known simply as ELISA, is the most commonly used immunoassay technique in the market. Compared to ELISA, D2Dx is much simpler and faster. With improved time, accuracy, and ease of diagnosis, critical health decisions can be made in real time.

Industry Advancements

ELISA immunoassays pose serious challenges for clinical laboratories to offer due to stringent regulatory framework, high cost, and pricing pressures. Requiring large and expensive equipment, the five to six hour ELISA testing process means that any sudden increase in demand for testing results in instant testing backlogs, as was the case during the US outbreak of the Zika virus in late 2016. In addition to limited throughput, ELISA’s extensive demands of laboratory personnel for running the lengthy tests and maintaining the complex instruments further contribute to the considerable expense of offering ELISA immunoassay tests.

The D2Dx platform enables labs to offer immunoassay tests at a fraction of the expense in a fraction of the time. The cost of a fully automatic system to perform ELISA with high throughput capability varies – commonly ranging between $1M to $2M; the Nano Discovery platform will be offered at a cost 10- to 20-fold lower. In contrast to the 5-6 hour ELISA test process, the D2Dx test is complete within as little as 5 to 30 minutes. The minimal turnaround times will allow laboratories to keep pace, even to sudden spikes to test volume. With the capability of processing 1,000 samples per hour per technician, labor costs are minimized. By significantly decreasing costs, D2Dx will enable more clinical laboratory service providers to offer testing, increasing both availability and affordability for patients.

Owing largely to the rapidly aging population, increased life expectancy, and the increasing prevalence of chronic infectious diseases, there is an ever-growing global need for rapid, affordable, and easily accessible diagnostic testing in healthcare – including an increasing demand for rapid immunoassay testing. With the footprint of a small, desktop printer, D2Dx offers a convenient and low-cost portable immunoassay platform for true point-of-care, rapid testing. The large, expensive machines currently used for testing are not readily available to those living in remote and underserved regions of the world.

Offering fast, accurate, affordable, and mobile point-of-care testing for the detection and diagnosis of infectious diseases, Nano Discovery’s D2Dx platform empowers people the world over with the information necessary to make informed and timely health decisions and takes the first step in addressing the global prevention and management of pathogenic diseases.

Patients concerned about exposure to the Zika virus in late 2016 wait to get care at a clinic in Colombia. Courtesy of WUSF News.

Map showing global examples of emerging and re-emerging infectious diseases.
Credit: NIAID.

Map showing global examples of emerging and re-emerging infectious diseases.
Credit: NIAID.