Background

Quality

OncompassTM Medicine, through its molecular diagnostics Laboratory, Oncompass Medicine Hungary Ltd (formerly KPS Ltd) has achieved 100% accuracy (sensitivity and specificity) in three independent external quality assurance (EQA) trials for KRAS mutation testing, including the EQA of the European Association of Pathologists.

Physicians found near 100% response rate to EGFR-TKI (erlotinib and gefitinib) in NSCLC patients harboring EGFR mutations identified by Oncompass Medicine (1). This is a higher correlation than found in clinical trials in which other methods and labs were used to select patients. This theoretically means that the same drug can be more successful in a biomarker based treatment or clinical trial if our diagnostic technology is used.

Oncompass Medicine is certified for ISO 9001.2008 quality standards.

Selected Certificates:
EQA_2012_KRAS SGS_UKAS_ISO9001_english KRAS_2010_QuIP_certificate KRAS_2010_EQA_certificate

1. Epidermal growth factor receptor (EGFR) high gene copy number and activating mutations in lung adenocarcinomas are not consistently accompanied by positivity for EGFR protein by standard immunohistochemistry. Pinter F, Papay J, Almasi A, Sapi Z, Szabo E, Kanya M, Tamasi A, Jori B, Varkondi E, Moldvay J, Szondy K, Keri G, Dominici M, Conte P, Eckhardt S, Kopper L, Schwab R, Petak I. J Mol Diagn. 2008 Mar;10(2):160-8.

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