Onco feels: breast cancer therapy will be selected by a single test
Clinical trials of the first domestic test system for the selection of therapy for breast cancer have been completed in Russia. It allows us to identify mutations in genes that provoke the development of a hereditary form of the disease, and at the same time determine sensitivity to targeted drugs for the appointment of personalized therapy. Previously, this required a whole range of complex analyses. And now the necessary studies will be performed using a single test, which will significantly speed up the process and reduce the burden on patients, experts told Izvestia.
Selection of breast cancer treatment
The first Russian new-generation genetic test for breast cancer patients has successfully passed clinical trials launched in 2024 at the Herzen Moscow Cancer Research Institute. This was reported to Izvestia by the press service of Sechenov University.
The Breast Cancer Target test system, developed at the Industrial Laboratory of Applied Genomic Technologies of the University in collaboration with a commercial partner, allows detecting mutations in genes that provoke the development of hereditary breast cancer, and at the same time determining sensitivity to targeted drugs for prescribing personalized therapy. And all this with the help of a single study. After receiving the Roszdravnadzor registration certificate, the test system will be implemented in clinical practice, the developers said. It will be used by oncologists and specialists from clinical laboratories performing molecular genetic research.
Until now, studies on genetic mutations in patients were conducted only by blood tests, and patients needed to perform a whole range of studies. The new test system makes it possible to detect mutations in a tumor sample, not only hereditary, but also acquired. In addition, it can be used to evaluate the sensitivity of tumors to targeted drugs in breast cancer patients, as well as to monitor the effectiveness of treatment.
Marina Sekacheva, head of the Laboratory of Applied Genomic Technologies and director of the University Institute of Personalized Oncology, told Izvestia that the test system makes it possible to perform all the necessary studies at once to prescribe personalized therapy to patients with breast cancer. With the help of a single test, the doctor will receive all the answers to questions about further treatment tactics, will be able to predict the potential resistance of the tumor and abandon schemes that will not be effective enough. To date, the test system has successfully passed technical and clinical trials.
— Clinical trials of our test system have already been completed, - said Marina Sekacheva. — They confirmed the test's ability to correctly detect genetic mutations for sequencing in patients with breast cancer. The test system showed high sensitivity and specificity. As a scientific method, this testing is already being used at the Clinical Center of Health Sciences at Sechenov University. After receiving the Roszdravnadzor registration certificate, we will replicate it in the country's clinics.
A test system for selecting cancer therapy
The Breast Cancer Target test, developed jointly with Sechenov University, combines the analysis of more than 20 genes: they will predict the sensitivity to drugs from current clinical recommendations, as well as the effectiveness of experimental therapies and drugs that will appear on the market in the coming years, the director of the OncoAtlas Center for Molecular Oncology (the development partner company) told Izvestia.) Vladislav Mileyko.
— That is, when new antitumor drugs are just being introduced into clinical practice, with the help of our test it will already be possible to determine whether they will help a particular patient or not, — he noted.
Breast cancer is one of the most common types of cancer. Both directions of the new test system research: The identification of mutations in genes, as well as the determination of sensitivity to targeted drugs for the selection of personalized therapy, are extremely relevant aspects of the diagnosis and treatment of this type of cancer, said Oleg Kaganov, market expert at NTI Helsnet, head of the Department of Oncology at SamSMU, Chief physician of SOCOD, MD, Professor Oleg Kaganov.
"Therefore, the introduction of these test systems into clinical practice is certainly both promising and in demand," the expert emphasized.
Such a test system will reduce the diagnosis from several weeks to 7-10 days, analyzing both hereditary and acquired mutations, as well as the sensitivity of the tumor to drugs, said Evgeny Sobolev, co-founder of biotech startup studio Scanderm, market expert at NTI Helsnet. However, in order to draw definitive conclusions, it is necessary to wait for the test to be introduced into clinical practice and evaluate the first results, the experts noted.
The Industrial Laboratory of Applied Genomic Technologies has become one of the winners of an open competition for projects implemented jointly with an industrial partner. The open competition is being held at the First Moscow State Medical University as part of the implementation of the strategic academic leadership program "Priority 2030".
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