mtm develops and manufactures IVD products according to ISO 9001:2000 and ISO 13485:2003 and in compliance with cGMP requirements.
mtm's patent protected family of products are based on mtm's proprietary E6H4™ antibody clone which was specifically developed for immunochemistry applications in both formalin-fixed paraffin-embedded tissue sections and alcohol fixed cervical cytology preparations. The target for mtm's cervical cancer early detection technology platforms is the evaluation of the over-expression of the cyclin-dependent kinase inhibitor p16INK4a. This biomarker is a direct indicator of the oncogenic activity of High Risk Human Papilloma Virus (HR-HPV) that marks the generation of cervical cancer. These biomarker-based diagnostic assays hold the promise to bring high levels of sensitivity and specificity towards the detection of high grade cervical disease in adjunctive uses with conventional technologies.
The CINtec® immunoassay products are based on the specifically designed antibody clone E6H4™ as the method for identifying p16INK4a in biopsy tissues and cytology specimens. The sensitivity and specificity of the E6H4™ antibody clone has been established and validated through over 50 clinical research studies. Importantly, E6H4™ shows no cross reactivity with Trichomonas (a protozoal infection of the vagina) that renders other antibody candidates unacceptable as generating too many false positives. The GMP manufactured kit components in combination with the optimized antibody ensures the reproducible quality and results in assessing a wide variety of biological specimens.
The CINtec® immunoassays are validated to provide a sensitive and specific method for the detection of p16INK4a in cervical tissues.
The currently marketed CINtec® In-vitro Diagnostics (IVDs) have been developed for application on: