The DiaPat® diagnostic method complies with the "Gesetz über Medizinprodukte" (MPG) and Directive 98/79 / EC of the EU on In Vitro Diagnostics (IVD). The method is therefore approved for use by medical professionals.
A quality management system guarantees maximum reliability and reproducibility of the results. DiaPat® meets the highest clinical standards.
A diagnostic test is considered medically and scientifically validated if it leads to an improvement in the medical diagnosis for the benefit of the patient in a prospectively blinded study with statistical significance (in a blinded study it is not known whether the test subjects are healthy or sick acts). Since the company was founded, DiaPat GmbH has been committed to this claim and is committed to providing comprehensive information about the possibilities of the method. Each study was carried out in accordance with the necessary scientific criteria and requirements:
- Clear definition of the clinical question and determination of the innovation potential for diagnosis and therapy
- Establish patient and control populations, required clinical data and protocols for sample collection and preparation
- Definition and validation of the analytical platform for the development process
- Obtaining the official approvals and declarations of consent from the study participants
- Execution of a pilot study on the already validated platform
- Statistical evaluation of the pilot study to determine the study participants required for the blinded study
- Implementation of a blinded, prospective study for clinical validation
- Complete disclosure of the study results in publications
- Control of the diagnostic effectiveness in the context of the current clinical situation
The following publication was published in this regard:
Recommendations for biomarker identification and qualification in clinical proteomics.
Mischak H, Allmaier G, Apweiler R, Attwood T, Baumann M, Benigni A, Bennett SE, Bischoff R, Bongcam-Rudloff E, Capasso G, Coon JJ, D'Haese P, Dominiczak AF, Dakna M, Dihazi H, Ehrich JH, Fernandez-Llama P, Fliser D, Frokiaer J, Garin J, Girolami M, Hancock WS, Haubitz M, Hochstrasser D, Holman R, Ioannidis JPA, Jankowski J, Julian BA, Klein JB, Kolch W, Luider T, Massy Z, Mattes WB, Molina F, Monsarrat B, Novak J, Peter K, Rossing P, Sánchez-Carbayo M, Schanstra JP, Semmes OJ, Spasovsk G, Theodorescu D, Thongboonkerd V, Vanholder R, Veenstra T, Weissinger E, Yamamoto T, Vlahou A
Sci Transl Med. 2010 Aug 25;2(46):46ps42