Blog: company news & events


“Added sensitivity of component-resolved diagnosis in hymenoptera venom-allergic patients with elevated serum tryptase and/or mastocytosis.” Michel J, Brockow K, Darsow U, Ring J, Schmidt-Weber CB, Grunwald T, Blank S, Ollert M.
Allergy. 2016 Feb 2. doi: 10.1111/all.12850 Pubmed Link

The new publication co-authored by PLS-Design colleagues evaluates the advantages of component-resolved diagnosis for mastocytosis patients. Approximately 5% of patients suffering anaphylactic reactions due to strong allergy against hymenoptera venom allergy show an elevated baseline of serum tryptase (sBT) and/or mastocytosis.
The sIgE sensitization pattern and diagnostic sensitivity in hymenoptera venom-allergic patients with elevated sBT levels and/or mastocytosis was tested with a panel of recombinant yellow jacket and honeybee venom allergens on a widely used IgE immunoassay platform.
It could be shown that for these high risk patients with elevated sBT levels and/or mastocytosis the use of molecular components and decreasing the threshold sIgE level to 0.1 kUA /L may be needed to avoid otherwise undetectable IgE to hymenoptera venom extracts in about 8% of such patients.

The publication clearly proofs the potential value of recombinant allergens in allergy diagnostics, especially for high risk patients. PLS-Design has patent-protected several hymenoptera venom allergens.

See PLS-Design’s information about Companion Diagnostics (CDx) andRecombinant Allergens here.

“Anaphylaxis to insect venom allergens: role of molecular diagnostics.” Ollert M, Blank S.
Curr Allergy Asthma Rep. 2015 May;15(5):26. doi: 10.1007/s11882-015-0527-z. Pubmed Link

The article reviews the state-of-art in molecular diagnostics in insect venom allergy.
New available recombinant venom allergens offer several promising possibilities for an improved diagnostic algorithm.

See PLS-Design’s information about Companion Diagnostics (CDx) andRecombinant Allergens here.

The PEGylated erythropoietin biosimilar Omontys® (Peginesatide) was taken off markets by the companies Affymax and partner Takeda Pharmaceuticals last month because of cases of fatal anaphylactic reactions in 0.2% of the patients in the US. The companies work together with the FDA to resolve the problem. The most likely reason for pulling the product off the market is an unexpected allergic reaction of new patients against the product or a contamination, maybe due to certain production parameters. Until now, no statement about the exact nature of the problem has been published. In the wake of the event, Affymax had seen a loss of approx. 85% of its share value and is now facing potential lawsuits filed in the name of investors.
See the Affymax announcement here.

In principle it would be possible to detect such IgE-related allergic anaphylactic reactions and pre-test patients before receiving the first infusion of the drug. In addition, due to the non-emergency nature of this treatment there is no critical time restriction on the test, potentially allowing for more complex and sensitive testing. So, it is not surprising, that companies now start to use the event in marketing, as can be seen here.

PLS-Design has realized the problem long before the Omontys® tragedy, promoting component-resolved Companion Diagnosics for allergic patients. The focus of these tests is to prevent future anaphylactic reactions by optimized immunotherapy.

PLS-Design has cloned and expressed an array of recombinant insect venom allergens to test allergic patients and determine the pattern of allergic reactions. Some patients might show unexpected mono-sensitizations, whereas other show a more distributed allergy pattern. The reaction patterns will be used to optimize the composition and concentrations of allergens for improvement of the efficacy of immunotherapies.
See PLS-Design’s information about Companion Diagnostics (CDx) here.

PLS-Design researchers and academic partners will present at the German Society for Allergology and Clinical Immunology (DAGKI) 25th Allergy-Workshop in Mainz (Germany) on 7th of March 2013.
See here for more information about the jubilee meeting.
The complete program can be found here.
Session 1
Key note : Molekulare Allergiediagnostik – ein echter Mehrwert für die klinische Allergologie
(Molecular allergy diagnostics – a true additional value for clinical allergology)
Prof. M. Ollert

Session 3
V20: IgE reactivity to a broad panel of CCD free bee venom allergens reveals diverse sensitisation profiles in bee venom allergic patients
Julian Köhler, S. Blank , S. Müller, F. Bantleon, J. Huss-Marp, J. Lidholm, E. Spillner, T. Jakob

V21: Polistes species venom is devoid of carbohydrate-based cross-reactivity and allows interference-free diagnostics
Simon Blank, C. Neu, D. Hasche, F. Bantleon, T. Jakob, E. Spillner

V22: Fine specificity of IgE and IgG carbohydrate reactivity dissected by establishing xenobiotic epitopes with glycoengineered cells
Frank Bantleon, S. Blank, M. Plum, T. Jakob, E. Spillner

V23: Structural and functional insights into the high affinity recognition of xenobiotic N-glycan core modifications by monoclonal antibodies from rabbit immune repertoires
Melanie Plum, F. Bantleon, M. Kötzler, J. Eckenberger, S. Wolf, S. Blank, A. Diethers, B. Meyer, E. Spillner

27 Feb / 2013

Omalizumab for urticaria study status

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In the online edition of the “New England Journal of Medicine” the first results from the Novartis Phase III study (ASTERIA II) of the use of omalizumab for chronic sponaneous urticaria (CSU) have been published. The data were also presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting in San Antonio, Texas, USA.
Novartis claims that the results indicate that Omalizumab is a potentially valuable treatment option for moderate to severe refractory chronic idiopathic or spontaneous urticaria (CIU/CSU). Novartis aims at a regulatory submission for this new application of Omalizumab in 2013.

See NEJM site for article:
Omalizumab for the Treatment of Chronic Idiopathic or Spontaneous Urticaria
Maurer M, Rosén K, Hsieh H-J, Saini S, Grattan C, Gimenéz-Arnau A, Agarwal S, Doyle R, Canvin J, Kaplan A, and Casale T.

See Novartis press release here.

IgE-Quantification can be used to monitor an anti-IgE therapy, like omalizumab treatment.
For example, the amount of remaining free IgE under omalizumab treatment can be quantified using PLS-Design‘s IgE-AviQuant molecule. Read more here!

From time to time PLS-Design will post references of peer-reviewed articles, which we find highly interesting for our field of activities.

This time we would like to point to two articles from the February issue of “Nature Immunology”. The articles show that the technology of PLS-Design to interfere with complement to modulate regulatory T cells is a hot topic (…who would have guessed that).

See also our page for PLS-Design‘s technology of complement interference.
For more information, please feel free to contact us (

23 Feb / 2013

Welcome to our new web site

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Hello World,

Welcome to PLS-Design’s new web site. To level with our R&D standards we deployed this improved web site.

This web site will allow closer communication with our customer and research partners, as well as providing hopefully interesting information to all others. We envision to extent this site to a preferred place of information and reference about immune system modulation, because – that is our Business!

PLS-Design joined the social cloud. You can now reach PLS in Twitter, Facebook and Google+…more to come.

We do hope you like our site and stay with us for a while. We will do our best to make it a pleasent stay – promised!

PLS-Design Admin

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