Scientists of the Federal Research Center “KSC SB RAS” and the Siberian Federal University have created a kit for the diagnosis of acute leukemia, which allows determining up to 18 mutations in blood stem cells. The development has proven its efficiency: the branch of the National Medical Research Center for Hematology, on the basis of the KSC SB RAS, received a state order from the Ministry of Health of the Russian Federation to develop the technology and conduct clinical trials among patients from different regions of the country.

In modern medicine, the procedure for medical assistance to patients is governed by the "Clinical guidelines", which are based on the advanced achievements in international practice. The introduction into practice of these recommendations is hampered by the poor availability of individual diagnostic tests. For example, the modern diagnosis of acute leukemia is based on the results of a genetic study of tumor cells. In Russia, unfortunately, use is still made of cytogenetic studies based on microscopy of dividing cells for diagnosing leukemia. However, there are more accurate and simple molecular genetic methods.

“We have received a state order from the Ministry of Health of the Russian Federation for the development of kits allowing multiplex detection of up to 18 different oncogenic RNA transcripts. The work is performed in close cooperation with the doctors of the Regional Hospital and Krasnoyarsk Regional Center for Maternal and Child Health, as well as with the staff of the National Medical Center of Hematology of the Russian Ministry of Health.

It is expected that if leukemia is suspected, blood samples will be drawn from the patient both for classical hematological analysis and for testing on our kits, which would allow detecting oncogenic RNA markers of tumor cells within two to three hours. We hope that next year our kits will receive a registration certificate to allow for their use in medical practice, ” said Igor Olkhovsky, Candidate of Medical Sciences, Senior Researcher of the Experimental and Clinical Hematology Group, FRC KSC SB RAS.

The pilot testing of the kit was performed within the framework of the "Umnik" competition of the Innovation Promotion Foundation. In 2017, the winner of the program was Ksenia Tabakova, master student of the Institute of Fundamental Biology and Biotechnology of the SibFU. Four years later, the project underwent a rapid development: a set of reagents was modernized and the number of detected genetic disorders characteristic of acute leukemia was significantly expanded.

At present, the diagnostic method is successfully used in the treatment of cancer patients in adults and children on the basis of regional clinical hospitals. All the patients with suspected leukemia are provided with an advanced high-tech analysis free of charge at the first diagnostic stage.

“Owing to the promptly performed analysis, the hematologist has a complete assessment of the genetic portrait of a tumor cell. This means that there is no need to send blood samples to federal centers and to wait for the results. The diagnosis can be confirmed in the very first days, which allows specialists to quickly prescribe a treatment course. This is especially important for patients with acute leukemia, since for efficient treatment of blood cancer it is necessary to detect the disease as early as possible, ”said Ksenia Tabakova, a master student at the Institute of Fundamental Biology and Biotechnology of the SibFU.

We would like to emphasize that the project is relevant for many regions where there is still no possibility of performing molecular genetic research on oncogenic mutations. Currently, the project participants are involved in the development of DBS cards used for the study of dry blood spots of a patient. Further development of the project will enable patients to do without visiting the hospital, because it will become possible to apply a blood sample directly to the card, and then send by mail to the laboratory of the medical center.

The information was provided by the PR-department of the Krasnoyarsk Regional Innovation and Technology Business Incubator (KRITBI) and the press service of the Siberian Federal University.