BUDAPEST, Hungary, Feb. 3, 2016 /PRNewswire/ -- Molecular assays developer NEUMANN Diagnostics Ltd. today unveiled its CONFIDENCE™ molecular test portfolio setting a new standard in cervical cancer screening.
The tests demonstrated superior accuracy achieving very high sensitivity without compromising on specificity. In HPV-positive women aged 25 years or older sensitivity for severe cervical dysplasia or worse condition at baseline was 91.94% (95% CI 82.17 – 97.33) meanwhile specificity in the same group was 74.35% (95% CI 71.78 – 76.81).
The CONFIDENCE™ test portfolio (consisting of a human papillomavirus test (HPV) and an epigenetic biomarker) was evaluated in a multicentre clinical trial involving over 7,000 cervical samples collected from over 6,000 women. This clinical trial makes the CONFIDENCE™ biomarker the most validated epigenetic biomarker for cervical cancer diagnostics.
"We are very pleased with the results of the study. This is the first highly accurate screening method in the world with fully automated evaluation," said Miklós Nyíri, managing director of NEUMANN.
Initially NEUMANN intends to introduce the test to complement current screening methods. Its biomarker test can help substantially 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" – said Nyíri. "We recommend using the CONFIDENCE™ tests on all samples which did not get a severe dysplasia diagnosis – because there is a potentially undetected underlying disease."
In the clinical trial 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, with a proprietary algorithm, can establish the individual risk of each woman for cervical pre-cancer or cancer.
One of the first clients of NEUMANN for its HPV diagnostics technology is the Synlab GenoID Molecular Laboratory, part of the Synlab Group, Europe's largest laboratory network.
The aim of NEUMANN is to prove its method can be a standalone solution for cervical cancer screening in any environment – including in developing countries where cytopathology is non-existent.
NEUMANN develops automated diagnostic testing systems for cancer screening and STDs. The company is majority owned by the X-Ventures Beta Venture Capital Fund co-financed by Hungarian private investors and the EIB in the Joint European Resources for Micro to Medium Enterprises (Jeremie) program.
Ms Anna Faludi