Roche is buying German in vitro diagnostics firm mtm laboratories for €130 million (almost $184.04 million) up front and potentially another €60 million (about $84.93 million) in performance-related milestones. Mtm’s CINtec® cervical cancer diagnostics portfolio is based on its E6H4™ antibody clone for identifying p16INK4a in biopsy tissues and cytology specimens.
Roche says the portfolio will complement its own cobas HPV assay for cervical cancer screening, which was launched in the U.S. in April. “As a result of the acquisition, Roche will have a comprehensive portfolio offering for cervical cancer testing from cytological screening to histological diagnosis,” notes Daniel O’Day, COO at Roche Diagnostics. “The combination of cobas HPV and p16 tests may redefine the standard of care for cervical cancer testing by improving detection, reducing unnecessary cervical biopsies, and improving the confirmation of cervical precancer.”
mtm’s CINtec Plus Cytology kit is approved in Europe for identifying overexpression of p16 in cervical Pap test samples to detect precancerous lesions. In the U.S. CINtec Plus is currently only available for research use, but Roche says it will pursue FDA premarket approval based on planned clinical trials. The German firm’s CINtec Histology Kit is available worldwide as an IVD product (class I IVD in the U.S.) for qualitative detection of p16 antigens for the qualitative detection of the p16 protein on slides prepared from formalin-fixed, paraffin-embedded cervical biopsies. Roche says FDA premarket approval is in the planning phase.
mtm is separately developing additional diagnostics, including Cervatec™ ELISA, an advanced version of the CINtec® product to detect p16INK4a. Cervatec ELISA is intended to be used in addition to the Pap Test for women aged 35 and younger, and is CE-marked for in vitro diagnostic use. The assay is based on two monoclonal antibodies for p16, including antibody clone E6H4™.