Autoimmune Diagnostics: Analyst Q&A

Autoimmune Diagnostics: Analyst Q&A

Questions and Answers From the Analyst, for Kalorama Information's latest report, AutoImmune IVD Market

Where is revenue growth in AutoImmune Testing?
A little less than three percent per year, so around average for global IVD, but that belies much stronger growth in some segments, notably diabetes and celiac.

What’s driving growth in autoimmune?
Growth will be driven by type 1 diabetes (HbA1c), gastrointestinal disorders and other diseases. Also, Because the population is aging and there will be more women aging, they are going to be affected more often than men with autoimmune diseases. This will likely create a large demographic that will benefit from novel and sophisticated autoimmune IVD diagnostic testing.

What companies participate in the market?
The lead companies are INOVA, Bio-Rad Laboratories, Hycor and Thermo Fisher Scientific.

What type of Tests are in this market?
ANA Tests are first-run. The antinuclear antibody (ANA) test - is still performed primarily by IFA, although increasingly laboratories have been shifting to the ELISA method because ELISA automates and standardizes the ANA test. ANA screening by IFA is labor-intensive and requires visual interpretation of the stained pattern by microscope. The test is performed by a specifically trained technician.

What’s an important trend that the report found?
Proteonomic research in autoimmune diseases is leading to the development of ultrasensitive test methodologies. Research derived from the Human Genome Project is expected to lead to a number of revolutionary therapeutics that will further cut the morbidity and mortality of a number of disease including diabetes, asthma, autoimmune diseases and cardiac diseases.

Also, Automation. Diagnostic companies are continuing to gradually improve these fully automated platforms. In addition, many companies are working to develop innovative new platforms. Demand for healthcare and diagnostic tests in all the major markets is driven by aging populations and increased incidence of autoimmune conditions. In light of the demand for these tests, they have been reformulated for automated analyzers where the cost per test is traditionally low.

What future trends are on the way?
Automation, already improving, gets better: A next step in automation is multiplex systems for the simultaneous measurement of autoantibodies based on microspheres (beads) coated with specific antigens and flow cytometry detection. These tests have been available since early 2000s. Multiplex ANA tests usually detect the most common autoantibodies including: dsDNA, Chromatin, Ribosomal protein, SS-A (52 and 60), SS-B, Sm, Sm/RNP, RNP (A and 68), Scl-70, Jo1 and Centromere B antibodies. With this method, ANA screen reports show the actual levels of individual analytes. Here too, further confirmation can be made using the IFA method.  Market leader INOVA Diagnostics has been leading the way for automation of the ANA test. INOVA’s FDA cleared NOVA View automated IFA microscopy is a technology that fundamentally changes the way IFA is performed in diagnostic testing.