Genetic Center Develops a Test for Genetic Research of Tumors

The Center for Genetics and Reproductive Medicine Genetics, a resident of Skolkovo and a portfolio company of the RVC Bio fund, has developed the test named Onconetix to search for mutations in a tumor and began its implementation into practice with partner clinics.

The study will help sel ect the most effective cancer therapy individually for each patient, taking into account the genetic characteristics of their tumor.

Currently, the Genetic laboratory is conducting clinical approbation of the Onconetix test with leading Moscow oncologists to determine the clinical significance of this study and its place in treating oncological diseases.

Testing is carried out by the sequencing (decoding) DNA of a new generation (NGS). Depending on the indication, 20 or 48 genes are examined for mutations of clinical significance.

As a result of testing, the patient receives a conclusion describing the identified clinically significant mutations and a list of targeted medications, the response to which is associated with the identified mutations. Targeted drugs increase cancer therapy's effectiveness because they are aimed at a specific target and only target certain tumors when there are identified gene mutations.

At this stage, the Onconetix test recommended for the following groups of patients:

• Patients diagnosed with cancer who have multiple targeted therapy options (e.g., lung cancer).

• Patients diagnosed with cancer who have ceased to benefit fr om therapy prescribed based on clinical standards.

• Patients diagnosed with cancer for which there are no clinical treatment standards.

Currently, research Onconetix is available in the Genetic laboratory and in the partner clinics that participated in the validation. In the future, it is planned to produce industrial samples of test systems for use in other laboratories.

Daria Khmelkova, Head of the Laboratory of Oncogenetics, Genetic Center: "Onconetics research is our own development. We analyzed Russian and foreign recommendations for the treatment and diagnosis of oncological diseases and panels available on the market in Russia and abroad for searching for somatic mutations in tumors. Based on this analysis results, we selected a list of genes with the most significant clinical significance and targeted areas in these genes wh ere clinically significant mutations are reliably described. The result is a unique panel comparable in size and cost to some of the smaller commercial panels fr om manufacturers such as Illumina and ThermoFisher. At the same time, unlike these panels, Onconetics includes such essential genes as the histone genes (H3F3A, HIST1H3B, HIST1H3C) and the TERT gene promoter, which are necessary for diagnosing patients with CNS tumors, and the MET gene region, in which mutations lead to skipping of exon 14 and are associated with response to specific targeted therapy in lung cancer".

Mikhail Fedotov, the Director of RVC subsidiary funds: "Despite the negative impact of COVID-19 on all technological innovation market participants, Genetic demonstrates sustainable development, maintaining profitable growth and development rates. Even small companies researching cell and gene therapy have a good chance of success, including in the framework of combined treatments for oncology. However, one of the main conditions is to bridge the gap between development and their subsequent commercialization and scaling. Therefore, today it is vital to support these developments and make such services available and known to many patients".

The Oncogenetics Laboratory has been working at the Genetic Center since 2018. Its tasks include developing and implementing molecular genetic studies for patients with cancer to select the most effective targeted therapy aimed at the selective destruction of cancer cells. The laboratory is also engaged in diagnosing a hereditary predisposition to genetically determined genetic diseases associated with an increased risk of cancer.