A Medical Device Daily
mtm laboratories (Heidelberg, Germany), a cancer diagnostics company, reported the European launch of its CINtec Cytology kit with extended claims for the diagnosis of cervical cancer.
The clinical claims are derived from the outcome of a recent pan-European pivotal study involving pathologists and cytotechnologists from France, England, Spain, Italy and Germany.
The multi-center trial was conducted to determine the sensitivity and specificity for the detection of underlying high grade disease for women with ASC-US (equivocal) or Low Grade (mild abnormality) cytology results to High Risk HPV (HR-HPV) testing.
The company said the overall sensitivity for the detection of CIN2 and higher grade disease exceeded 92%, which was essentially the same as that of HR-HPV testing. However, the specificity of CINtec Cytology was 67% to 100% higher than that of HR-HPV testing.
Ruediger Ridder, chief scientific officer of mtm laboratories, said, "Equivocal or mild results such as those examined in the study are clinically relevant, since a portion of these actually harbor high-grade disease, the immediate precursor to cervical cancer, and as such cannot be ignored."
He added, "However, it is costly and inefficient to treat or manage all of the cases based on the initial cytology finding, which is why a more accurate biomarker-based test such as CINtec Cytology is needed to pinpoint those cases where there is high grade disease."
Company CEO Bob Silverman said, "Approximately 6% to 8% of Pap test results will be equivocal or mildly abnormal. While the majority of these diagnoses are benign, 10% to 15% of these cases will harbor high-grade disease, creating a clinical dilemma for clinicians. The results of this trial demonstrate that CINtec Cytology can more accurately identify those women with high-grade disease than managing these cases with HR-HPV testing."
Silverman added, "This is a major advance in cervical cancer screening, and for the women participating in screening programs."
The CINtec Cytology Kit is an immuno-cytochemistry assay for the qualitative detection of the p16INK4a antigen on cervical cytology preparations. It is intended to be used as an aid in the identification of women with underlying high-grade cervical intraepithelial lesions in the sub-group of patients with a Pap cytology result of ASC-US (atypical squamous cells of undetermined significance) or LSIL (low-grade intraepithelial lesion).
Italian hospital adds Hi Art system
TomoTherapy (Madison, Wisconsin) said that Azienda Ospedaliero-Universitaria di Modena (Modena, Italy) has selected the company's Hi Art treatment system for advanced radiation therapy.
Stefano Cencetti, MD, executive director of Azienda Ospedaliero-Universitaria di Modena, said, "Thanks to the perfect cooperation and planning between the hospital and TomoTherapy, we took delivery of our TomoTherapy system and just 30 days later, we were imaging and treating our first patient."
Jef Van Dam, general manager of TomoTherapy EMEA, added, "TomoTherapy continues to prove our strength in rapid machine installation to enable departments to minimize the time a bunker is non-operational. Pre-commissioning of the Hi Art system and excellent physics and applications support saves costly resource hours in commissioning and testing."
Azienda Ospedaliero-Universitaria di Modena is the first university center in an Italian public hospital to invest in radiation technology to provide the most advanced treatments available. Its clinicians plan to investigate new treatment opportunities using image-guided and adaptive radiation therapy with the Hi Art system.
The center covers radiation treatment for 13% to 15% of the regional population, with 30% of those treatments considered complex or specialized and available in few hospitals within the region.
Azienda Ospedaliero-Universitaria di Modena is one of six hospitals to offer TomoTherapy in Italy.