Trials of a single test for the selection of breast cancer therapy have been completed in the Russian Federation

Clinical trials of a single test for the selection of breast cancer therapy have been completed in the Russian Federation. The first Russian new-generation genetic test for breast cancer patients has successfully passed clinical trials, which began in 2024. They were held at the Moscow Scientific Research Oncological Institute named after P.A. Herzen.

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The Breast Cancer Target test system, developed at the Industrial Laboratory of Applied Genomic Technologies of the University together 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.

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.

"The clinical trials of our test system have already been completed. 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 for Health Sciences at Sechenov University. After receiving the Roszdravnadzor registration certificate, we will replicate it in the country's clinics," Sekacheva said.

The Breast Cancer Target test, developed jointly with Sechenov University, combines the analysis of more than 20 genes that predict drug sensitivity from current clinical recommendations.

Read more in the exclusive Izvestia article:

Onco feels: breast cancer therapy will be selected by a single test