News

March 14, 2024

Extended screening program for the early detection of occupational mesothelioma (EVA-Mesothel)


"The number of occupational mesotheliomas is still at a high level despite the ban on asbestos in 1993 in Germany. In 2021 the German Social Accident Insurance (DGUV) reported about 700 new cases of recognized occupational mesotheliomas. Usually, these tumors are discovered at advanced stages when the cancer has spread and treatment options are very limited.

The MoMar studies (MoMar, MoMarFollow) showed that the combination of the biomarkers mesothelin and calretinin could detect mesotheliomas up to a year earlier than with established diagnostic methods. Usually, an earlier detection results in an earlier stage of the cancer. The detection of cancer at less advanced stages offers more treatment options and could help to treat earlier, potentially resulting in better outcomes. Based on these results a new, effective screening program without radiation burden will be offered to insured persons with occupational exposure to asbestos. Initially, the offer will only be made to a selected high-risk-group, i.e., persons with recognized asbestosis, pleural plaques and/or other benign asbestos-related diseases of the pleura.

To achieve this, the DGUV founded the taskforce „Therapy of Mesothelioma“ in 2019. This taskforce initiated and designed the program „EVA-Mesothel“. The screening comprehends an annual medical examination including blood checks for the biomarkers.

EVA-Mesothel started as a pilot phase in spring 2023 for the central region of the Rhine-Ruhr metropolitan area for persons insured by five statutory accident insurances being in charge in the field of mining and chemical industries (BG RCI), wood and metal processing (BGHM), building and construction industries (BG BAU), energy, textile industries, electronics and publishing (BG ETEM), and trade and logistics (BGHW). These institutions are providing work-related prevention, health care and rehabilitation services, and workers' compensation. The program is monitored scientifically by the Institute for Prevention and Occupational Medicine of the DGUV (IPA).

The new program EVA-Mesothel is linked to further measures that were initiated by the taskforce:
Offer of special consultation and further diagnostics for patients with elevated biomarkers. The consultations will take place at certified centers with extended knowledge in diagnosing and treating mesotheliomas. The centers are called „mesothelioma units“ and have been certified by the German Cancer Society (DKG): https://oncomap.de/centers?selectedOrgan=Mesotheliom

  • Offer of consultation for patients with already diagnosed mesothelioma at the mesothelioma units, e.g., for second opinion, special diagnostics and/or treatment.

  • Offer of individually best therapies for insured patients with mesothelioma, accompanied and supported by the rehabilitation management units of the statutory accident insurances

  • Ongoing development and evaluation of mesothelioma biomarkers for prognosis, prediction, and monitoring of treatment

  • Development of a schedule of fees to reimburse certified mesothelioma units and doctors taking part in EVA-Mesothel

  • Fostering scientific and medical exchange and networking between the mesothelioma units with special discussion panels on mesothelioma therapy and by using the dedicated mailing list „MesoTheraNet“

Procedure of the pilot phase of EVA-Mesothel:

  1. The above-mentioned group of eligible persons will get an invitation from their respective statutory accident insurance (BG RCI, BGHM, BG BAU, BG ETEM, or BGHW) and then make an appointment for a doctor’s consultation.
  2. During the consultation doctor and patient will first discuss the individual advantages and possible risks of the screening.
  3. Only afterwards the patient has to make the decision whether to take part in the biomarker screening and/or the scientific monitoring.
  4. After anamnesis and physical examination, a blood sample is taken. During the pilot phase the blood sample is being analyzed at a special laboratory in the city of Duesseldorf.
  5. If the result of the blood test is not elevated, the first round of examinations is completed and the next blood sample will be drawn after one year.
  6. Is one of the biomarkers elevated or are there other potential signs of a mesothelioma (e.g., pleural effusion found during the physical examination) EVA-Mesothel will be concluded for this individual patient. The patient will get an appointment at a mesothelioma unit for a special consultation in order to verify the findings. In the pilot phase this will be the Ruhrlandklinik Essen.
  7. If the additional diagnostics performed during the special consultation results in a verification of the mesothelioma diagnosis, the patient will be offered treatment at highest standards according to current guidelines and, if desired, in close cooperation with the rehabilitation management of the responsible statutory accident insurance.

If the two-year pilot phase can be completed successfully, EVA-Mesothel will be extended to all other statutory accident insurances and all federal states of Germany. In the meantime, EVA-Mesothel is going to be fine-tuned using the experiences made during the pilot phase."


Cited from: https://www.dguv.de/ipa/eva-mesothel/index.jsp

Please do not hesitate to request more information about our biomarker Calretinin for the earlier diagnosis of malignant Mesothelioma. Also, we would be happy to inform you about the special laboratory, which is being analyzed the blood samples during the pilot phase.

Photo: https://pixabay.com/de/vectors/asbest-achtung-warnung-gefahr-39996/ free license


March 5, 2024

CAR T-cell therapy offers hope for autoimmune diseases


Initial successes with CAR-T-cell therapies for myasthenia and other autoimmune diseases give great hope.

Chimeric (auto) antigen receptor T-cells (CAR-T-cells) are immune cells, more precisely T-lymphocytes, which are taken from the patient and specifically activated against certain endogenous structures outside the body (in vitro; in a test tube) by means of genetic engineering. After being reinfused, these CAR-T-cells can recognize the target structures in the body and destroy the targeted cells permanently.
Research is still in its beginnings: only around 100 people with an autoimmune disease have been treated experimentally with CAR-T-cells. In some cases, impressive successes have been achieved, e.g. in a young patient with myasthenia, a severe neurological autoimmune disease. In myasthenia gravis - myasthenia for short - misdirected antibodies block the signals between nerves and muscles. The patient was dependent on a wheelchair for longer distances and her breathing became increasingly weaker. As a last resort, the patient received CAR-T-cell therapy at Bochum University Hospital. The myasthenia patient can now do physical activities again.

CAR-T-cells remove B cells and thus harmful autoantibodies
These successes are possible because CAR-T-cells destroy certain immune cells in patients: The so-called B-cells. In a healthy immune system, B-cells produce antibodies that mark invaders and thus make them visible to other immune cells that can eliminate these invaders. In autoimmune diseases, B-cells have developed that release antibodies against the body's own structures, so-called autoantibodies - with fatal consequences.
In CAR-T-cell therapy, T-cells, another type of immune cell, are genetically modified in the laboratory. These T-cells recognize the B-cells in the body and destroy them. The harmful antibodies disappear along with the B-cells.

Large studies must confirm the results of CAR-T-cells
And the same applies to myasthenia: as promising as the results are so far: They still need to be confirmed by large-scale studies. The researchers are expecting seminal results as early as 2025. If these are positive, the first approvals of CAR-T-cells for autoimmune diseases could soon follow.

DLD Diagnostika GmbH can make a major contribution to this for patients with its large product range of in vitro diagnostics for the detection of autoimmune diseases, e.g. myasthenia gravis and paraneoplastic syndromes. 
Request more information about our neurological biomarkers for the diagnosis of:


•    Myasthenia gravis
•    Lambert-Eaton myasthenic syndrome (LEMS)
•    neuromyotonia
•    Thymus carcinoma
•    Neuromyelitis optica (Devic syndrome)


Passages quoted from:
https://www.swr.de/wissen/car-t-zell-therapie-macht-hoffnung-bei-autoimmunkrankheiten-100.html
https://dmg.online/2023/12/13/car-t-zell-therapie-bei-myasthenie/



April 3, 2023

Canine ACHRAB® RIA: A new RIA for the diagnosis of myasthenia gravis in dogs


"Clinical validation of a new radioimmunoassay for the diagnosis of myasthenia gravis in dogs.

Introduction: Acquired canine myasthenia gravis is an autoimmune disease of the neuromuscular endplate. Pathophysiologically, it is a post-synaptic neuromuscular transmission disorder due to antibodies against acetylcholine receptors (AChR-Ab). The leading symptom is effort-dependent weakness, which is very often associated with megaesophagus. The diagnostic gold standard is considered to be the determination of AChR-Ab by radioimmunoassay (RIA) in serum. Although early diagnosis of these severely diseased dogs is essential for therapy, the test has only been available in the USA (San Diego). The aim of the study was to clinically validate the newly developed Canine ACHRAB® RIA.

Material and Methods: Acetylcholine receptor antibodies were measured in the serum of 238 dogs using the Canine ACHRAB® RIA at Biocontrol, Ingelheim, Germany). Sixteen dogs with myasthenia gravis, 40 with other neuromuscular diseases or megaesophagus (control group 1), and 182 dogs with other diseases (control group 2) were studied. In 68 dogs, AChR-Ab were also determined in the reference laboratory in the USA.

Results: At a cut-off of 1.3 nmol/l, the Canine ACHRAB® RIA showed a sensitivity of 100%, a specificity of 98.20%, a PPV of 80.00% and a NPV of 100%. When only dogs with neuromuscular disease and megaesophagus were considered, the results were as follows: Sensitivity 100%, Specificity 97.50%, PPV 94.12%, NPV 100%. When compared with the reference method, the new RIA showed mostly higher readings and appeared more sensitive in individual patients.

Conclusion: The test offers a promising alternative for the evaluation of patients with exertion-dependent weakness and megaesophagus."

 

Translated orig. citation from: Tierarztl Prax Ausg K Kleintiere Heimtiere 2023; 51: 55–62
DOI 10.1055/s-0043-1760812

Authors Bauer H1, Buhmann G1, van Renen J1, Steinberg T2, Putschbach K3,
Fischer A1

Institute 1 Medizinische Kleintierklinik, Ludwig-Maximilians-Universität
München, München; 2 AniCura Tierklinik Haar, Haar; 3 Tierärztliches
Gesundheitszentrum Piding, Piding

Photosource: Ylanite on Pixabay


Nov. 1, 2021

INCREASED SERUM LEVELS OF SDMA AND ADMA AT HOSPITAL ADMISSION PREDICT IN‑HOSPITAL MORTALITY OF COVID‑19 PATIENTS


Researchers at the University Medical Center Hamburg-Eppendorf (UKE) and the University Hospital Aachen discovered two biomarkers, which can predict a severe course of a corona infection early on: ADMA and SDMA. By determining the serum concentration of these biomarkers at admission to the clinic, intensive care treatment modalities could be initiated earlier and the chances of survival improved.

So far, it has been difficult to predict a severe course of the corona disease. Age, previous illnesses and clinical laboratory findings were used as starting points, but were able to predict the severity of the infection only to a limited extent.

The Scientists conducted a pilot study with 31 subjects and could identify two human biomarkers in serum: Asymmetric (ADMA) and Symmetric Dimethylarginin (SDMA); two metabolites from protein metabolism. "The results of our investigations show that patients who had high levels for both markers at the time of hospitalization, had a mortality risk of 88 percent, while all COVID-19 patients with low concentrations of both markers survived," says Dr Juliane Hannemann. * A large multi-center study to confirm the results is planned.

For the determination of ADMA and SDMA, the scientists used the highly specialized method LC MS/MS. In their publication released in Scientific Reports (Nature Publisher) they point out that “ADMA and SDMA may be measured by ubiquitously available laboratory methods”.

Our SDMA Human ELISA and ADMA Fast ELISA are well suited for this task. They are validated against LC-MS/MS (R=0.983 or R=0.987) and are both CE marked.
Contact us for more information!



*Cited from: Pressemitteilung vom 10.05.2021 11:41 UKE-Forschende identifizieren Biomarker zur Einschätzung schwerer COVID-19-Verläufe; Saskia Lemm Unternehmenskommunikation Universitätsklinikum Hamburg-Eppendorf

Original publication: Hannemann J, Balfanz P, Schwedhelm E, Hartmann B, Ule J, Müller-Wieland D, Dahl E, Dreher M, Marx N, Böger R. Elevated serum SDMA and ADMA at hospital admission predict in-hospital mortality of COVID-19 patients. Scientific Reports 2021; May 10
https://www.nature.com/articles/s41598-021-89180-w

Foto: https://pixabay.com/de/illustrations/corona-coronavirus-virus-covid-19-4959447/ free license



Aug. 31, 2021

We are excited to introduce two new RIA products!


  1. LEMS® N-type Assay RIA
    Determine the second most prevalent antibody in patients with LEMS

  2. ACHRAB® Ganglionic Assay RIA
    Specifically associated with Autoimmune Autonomic Ganglionopathy (AAG) and gastro-intestinal dysmotility


The LEMS® N-type Assay RIA is for the quantitative determination of autoantibodies to N-type Voltage-gated Calcium Channels (N-VGCC). The assay complements the LEMS® Assay RIA, which is used for the detection of autoantibodies against P/Q-type VGCCs.

VGCCs are a multimeric family of proteins with autoantibodies targeting the P/Q-, N- and L-types in LEMS. About 85-90% of patients with LEMS are positive for VGCC antibodies. Of these, antibodies targeting the P/Q-type VGCC are found in a significant proportion of patients with LEMS. Antibodies against N-type VGCC are the second most prevalent antibody in patients with LEMS; detected in 33-73% of patients diagnosed with paraneoplastic LEMS.

Serum autoantibodies reactive with N-VGCC were reported initially in dysfunction of the neuromuscular junction, specifically associated with Lambert-Eaton Myasthenic Syndrome (LEMS). Subsequently, N-VGCC Abs were detected in disorders of the central nervous system, including cerebellar degeneration and in paraneoplastic autoimmunity, particularly associated with Small Cell Lung Cancer (SCLC).

N-type VGCC autoantibodies are also detected in association with a variety of inflammatory neurologic autoimmune disorders including limbic encephalitis, neurodegenerative, psychiatric, seizure and movement disorders.

Functional N-VGCCs consist of a pore-forming alpha1-subunit together with ancillary beta, gamma and alpha2/delta subunits and are expressed widely in the central and peripheral nervous systems. N VGCC Abs primarily bind to the alpha1-subunit.


The ACHRAB® Ganglionic Assay RIA is for the quantitative determination of autoantibodies to Ganglionic Acetylcholine Receptors (gAChR) in human serum.

This Assay can be used to detect serum autoantibodies reactive with gAChR, which are implicated in impaired synaptic transmission at autonomic ganglia, specifically associated with Autoimmune Autonomic Ganglionopathy (AAG) and gastro-intestinal dysmotility. Functional gAChRAb are pentameric, consisting of alpha3 and beta4 subunits and are expressed predominately in autonomic ganglia. The gAChR Abs primarily bind to the alpha3-subunit.

These products are for research use only! Not for use in diagnostic procedures!


Photo: 'Epipedobates tricolor', a species of poison dart frog. Found on Flickr, [http://www.flickr.com/photos/deepinon/110593290/ here], user agreed to release under a free licence.