ARNA BC beats the breast cancer

The World health organization (WHO) points that breast cancer is the top cancer in women both in the developed and the developing world. This disease was the cause of the quarter of all deaths of cancer in 2012.

Even if the cancer is not directly related to a particular person, there surely everyone has a wife, daughter, sister, mother, grandmother, aunt, etc who had the same problem in varying degrees.

Just imagine! One in eight women in the United States will be diagnosed with breast cancer in her lifetime. On average, every 2 minutes a woman is diagnosed with breast cancer and 1 woman will die of breast cancer every 13 minutes.

ARNA BC is the first gene test developed by ARNA for the early breast cancer detection. The lab sensitivity and specificity of ARNA BC are both close to 95% rate. It means that currently, our test has no equals at the market from the point of view of the effectiveness of any other available or at the stage of development tests or diagnostic methods.

Its creator, Anatoly Melnikov, is the co-founder of ARNA Genomics and head of Research and Development (R&D). He graduated from the biological faculty of Lomonosov Moscow State University (MSU, Moscow, Russia). He has over 40 years of experience in the field of molecular biology and genetics and has authored and co-authored more than 50 scientific articles and several patents. In 15 years Anatoly Melnikov worked in cancer centers in the United States, before — in Canada, Hungary in various scientific companies, as well as in Russia. He discovered and described the phagemids, new class recombinant DNA.

The test ARNA BC is intended for women of all age groups, especially who are included into the National Screening Programs for breast cancer (women older than 35–40 years, depending on the country); who has in the anamnesis relatives with breast cancer; who received the result of mammography to clarify the result at the gene level; who is undergoing treatment of breast cancer to assess the effectiveness of the therapy, i.e. to monitoring of the tumor response to the treatment, as well as for those who looks after their health and the health of their loved ones.

Researchers sequence and methylate DNA during its extraction from blood plasma in advance. In our opinion, in this extraction is the key mistake, which doesn’t allow to get high precision measurements. The result of 10 years of research is our own technology platform of liquid biopsy. The ARNA BC effect test is based on the analysis of free circulating (circulating tumor) DNA in human blood plasma, which is determined by the PCR-PB method.

Indeed, in the modern world, where all processes are accelerated and screening methods don’t cover needs of the market and the patients — this technology will allow to save millions of lives!

All laboratory trials have shown that ARNA BC has very high accuracy. It shows unprecedented effectively results to detect tumors at early stages, not available yet for other methods of modern diagnostics. The results of laboratory studies of ARNA:

• Accuracy — 96%,
• Sensitivity — 98%,
• Specificity — 96%

The sensitivity and specificity of existing tests and other breast cancer diagnostic methods (mammography, MRI, examination, ultrasound, etc.) don’t exceed 70–80%. The specificity of biopsy is just over 90%. In other words, each 3–5 case of screening is mistaken, and most common leads to death.

We still have to admit that the results of ARNA BC, still need independent verification in accordance with international good practice. Therefore, we plan to prove the effectiveness of the test by conducting the most stringent clinical trials on FDA standards with its further registration as a medical device in the United States. In future, we plan to make research with its subsequent registration in other countries (India, China, EU, etc.).

ARNA BC demonstrates excellent sensitivity and validity in laboratory tests and seems to be functionally higher than all known breast cancer screening tools. After completion of clinical trials in USA and Russia this test will become a “golden standard” for diagnostics of breast cancer and will quickly replace all existing today methods.