September 24, 2019, Moscow, Russia –
ARNA Genomics US Inc., an innovative biotechnology company specializing in the development and implementation of diagnostic methods for early cancer detection, announced the successful completion of a proof-of-concept study with valid evidence results of the test in vitro diagnostic for early breast cancer detection “ARNA Breast”.
An open observational clinical and laboratory study of the proof-of-concept “Analysis of the effectiveness of ARNA Breast method for the diagnosis of breast cancer” was conducted at the Research Center for Personalized Oncology Research Institute of Personalized Medicine of I.M. Sechenov First Moscow State Medical University (Sechenov University).
The study analyzed plasma samples taken from women aged 18 to 75 years old with a newly diagnosed and histologically confirmed diagnosis of breast cancer of all biological subtypes before the appointment of any type of therapy and in healthy volunteers. The final analysis included 80 biosamples. According to two laboratory analysis protocols, the following statistically significant results were obtained: sensitivity (SE) = 100.0% (79-100% CI 0.99), specificity (SP)=85% (59-97% CI 0.99), negative predictive value (NPV) = 100.0% (79-100% CI 0.99), positive predictive value (PPV) = 85% (59-97% CI 0.99).
CEO and Founder of ARNA Genomics US Inc. Egor Melnikov said: “We are encouraged by the data that we have been moving to for more than 5 years, and we believe that the result can be a bright and attractive signal for Russian and foreign investors not only from the field of “technologies for women”(Femtech), but also from biomedicine and biopharmaceuticals in connection with own scientific platform in the field of “liquid biopsy” – ARNA, which allows to create tests for the early detection of various types of cancer based on blood plasma analysis.”
According to the company, the implementation of ARNA Breast test in clinical practice can be of great practical importance for Russian health care, in particular, when conducting routine physical examinations and annual prophylactic medical examination (screening) of the population, especially at-risk groups – women older than 50 years and not having nodal formations in breast tissue or previously not detected by traditional instrumental methods.
ARNA Genomics US Inc. – Biotechnology company focused on the development of liquid biopsy technologies. Based on the basis of a research laboratory, it is engaged in the development and research of methods for the early cancer diagnosis and the introduction of diagnostic tests on the markets for early cancer detection. The company sees its mission in extending and improving the quality of life of people through the widespread adoption worldwide of the latest screening methods, early diagnosis and monitoring of the treatment of cancer, which have no analogues in the effectiveness of screening.
ARNA Breast is an in vitro diagnostic test based on a combined analysis of the content of oncogenes fragments in cell-free DNA and plasma enzyme activity for the early breast cancer detection in women.