Neumann Diagnostics Ltd, Budapest, Hungary, recently unveiled the Confidence molecular test portfolio for cervical cancer screening.
According to the company, tests demonstrated a 91.94%. (95% CI 82.17–97.33) sensitivity in women who tested positive for human papillomavirus (HPV) aged 25 years or older for severe cervical dysplasia or worse condition. Specificity in the same group was 74.35% (95% CI 71.78–76.81).
The test portfolio, consisting of an HPV and an epigenetic biomarker, was evaluated in a multicenter clinical trial involving more than 7,000 cervical samples collected from more than 6,000 women. According to the company, the Confidence biomarker is the most validated epigenetic biomarker for cervical cancer diagnostics.
“We are very pleased with the results of the study,” says Miklós Nyíri, managing director of Neumann. “This is the first highly accurate screening method in the world with fully automated evaluation.”
Initially Neumann intends to introduce the test portfolio to complement current screening methods, aiming to help increase the sensitivity of Pap testing without impacting specificity.
“What is needed the most today is increasing sensitivity of the current screening system and finding women in need of treatment as early as possible,” says Nyíri. “We recommend using the Confidence tests on all samples that did not get a severe dysplasia diagnosis because there is a potentially undetected underlying disease.”
In clinical trials, the Confidence tests found severe cases up to 12 months earlier than Pap smear. When no sign of malignancy is found with conventional methods, Neumann’s test along with a proprietary algorithm can establish the individual risk of each woman for cervical pre-cancer or cancer.
One of Neumann’s first clients for its HPV diagnostics technology is the Synlab GenoID Molecular Laboratory, Budapest, Hungary, part of the Europe-wide lab network Synlab Group.
The company expects that both of its kits will soon receive the IVD CE mark.
For more information, visit Neumann Diagnostics.