19 March 2020

Closing in on the Complete Panel.

By Eleanor Doolin

It’s your body’s way of combating infectious disease and infection. So, when something goes wrong with your immune system, it can be a big worry.

Autoimmune diseases affect 24 million people in the US, with a further eight million likely to develop one of these diseases later in their lifetimes.

There are approximately 80 known autoimmune diseases in the world. Some you’ll name off the bat like type 1 diabetes, rheumatoid arthritis (RA), multiple sclerosis and celiac disease. However, others are rare and hard to recognise.

They’re caused by many things; ranging from whether a woman is in her childbearing years, to family histories, to sunlight exposure and more.

Many have similar symptoms, making them difficult to diagnose. This is problematic when speedy diagnosis is crucial to avoiding long-term effects and more serious diseases. For example, celiac disease can lead to bowel cancer if it’s not diagnosed and treated early.

Creating a test that's able to identify all autoimmune diseases in one go would be the golden-ticket diagnostic solution – speeding up diagnosis across the board. This product would take the global autoimmune disease diagnostics market by storm.

We’ve still a way to go until that milestone. However, that’s not to say the industry isn’t rife with life-changing innovation.

UK-based Immunodiagnostic Systems (IDS) are one of the closest to achieving the complete panel. This year they added seven new clinically relevant allergens to their now 67-strong allergy panel.

These additions include diagnosis for grass allergies, tree nuts (Hazelnut, Almond and Pistachio) and allergenic molecules (components) nGal d 1 and rPen a 1 which are associated with egg whites and shrimp.

Their IDS-iSYS instrument boasts a throughput of 450 allergy tests per day and can produce results in 40 mins. It can also run an allergy together with other IDS immunoassays like autoimmunity, infectious disease and endocrinology.

Now partnered with Omega Diagnostics, IDS are placed well to expand on their panel and offer a clinical portfolio that includes allergen extracts, components and mixes.

As a world leader in in vitro allergy diagnostics, Thermo Fisher supply 70% of laboratory tests worldwide and are also closing in on the complete panel.

Their lmmunoCAP lab tests accurately measure specific lgE antibody blood levels, as well as other important allergy risk markers. ImmunoCAP is one of the most important tools for understanding allergy. It helps clinicians make sense of symptoms such as rhinitis, eczema, wheezing and asthma.

This test has been validated in over 6000 clinical publications globally and gives access to over 550 clinical validated allergen tests.

That’s not all that Thermo Fisher are bringing to the table. Their top-of-the-line instrument, the Phadia 5000 Immunoassay Analyser, can meet the demands of any major lab delivering 25,000- 45,000 results per week (with a throughput of 7680 results every eight hours).

Both these instruments integrate with Thermo Fisher’s remote diagnostics LabCommunity. This software solution minimises the risk of losing valuable data and time through encrypted data transmission. It provides interactive online training - to increase knowledge sharing and improve quality assurance – and it has automotive proactive system health status checks.

Innova Diagnostics’ small benchtop analysers, the Bio-Flash and QuantaLyser, are equally valuable to this space – despite being further away from the complete panel.

Their compact design frees up lab space, while their impressive capacities of 480 samples minimise hands on time. This speeds-up diagnosis - generating up to 450 results in a single shift - and eliminates reagent waster. That’s because the stable on-board reagents allow for samples to be run as they arrive (they don’t need to be altered).

While these companies and other major corporations like Siemens Healthineers and DiaSorin have a strong hold on the market, many new exciting companies are coming to fruition.

Aesku have only been around ten years, yet they’ve already had great success and launched over 150 autoimmunity products worldwide. Other companies, like Orgentec and D-Tek, working in the advancement of novel biomarkers for prognosis of diseases are also expected to provide new opportunities in market growth.

As the industry continues to grow, it will continue to innovate. Further investment will lead us to faster tests, with bigger throughputs and possibly a complete panel.

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By Eleanor Doolin

Eleanor Doolin works as a Business Manager broadly within IVD but has previously spent time focusing specifically in clinical chemistry and oncology, plus advances in non-invasive diagnostic testing. She is always looking to connect with innovative individuals and organisations working in this area.

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