BioWorld International Correspondent

MTM Laboratories AG raised €22 million (US$27.6 million) in a Series C financing to fund further development and commercialization of its diagnostic products for detecting cervical cancer.

The Heidelberg, Germany-based company, which has raised a total of €41 million since its formation in 1999, has developed diagnostic methods for detecting cancerous and precancerous cells based on a biomarker called p16INK4a, a cell-cycle protein that is significantly overexpressed in cancers induced by human papillomavirus (HPV).

In 2001 it assigned rights to two products - CINtec Histology and CINtec Cytology - to Dako A/S, of Glostrup, Denmark, but having restructured that agreement earlier this year, it will take full responsibility for the production and the sales and marketing of both starting in 2007.

"Now we can really leverage its value ourselves," MTM CEO Peter Pack told BioWorld International.

The company had never out-licensed a third product, Cervatec, a biochemical screening tool available in an ELISA assay format.

MTM's strategy is based on reducing the strong element of doubt associated with routine smear tests.

"A lot of these pap tests are ambiguous. You don't get a clear result," Pack said. In the U.S., he said, $6 billion is spent every year on administering smear tests and on follow-up. And $3.6 billion of that total, he added, is spent on follow-up, even though less than 10 percent of tests require further analysis.

CINtec Cytology is designed for the cytological analysis of cervical smears and liquid-based cytological samples. CINtec Histology is designed to aid in diagnosis of cervical cancer in tissue biopsies. In each case, immunohistochemical staining of p16INK4a provides additional information to aid diagnosis, which otherwise is dependent on expert visual analysis of cell and nuclear morphology.

In the long term, the company aims to remove the necessity for expert analysis - a current bottleneck, Pack said - by establishing its Cervatec product as a clinically validated test. "We have to change clinical practice. We are fully aware there is a long way to go," Pack said. At present, it is positioned, along with CINtec Cytology, as an adjunct to current screening methods.

The company's products have a CE mark for the European market and a Class I research reagent designation in the U.S. It will use its latest cash injection to fund large-scale clinical trials in the U.S. and in Europe in order to obtain more clinical validation and to establish them as stand-alone in vitro diagnostics. "We are talking about substantial clinical trials," Pack said. The studies will involve several thousand subjects.