We are pleased to announce that ROSSA has successfully passed the audit and received the ISO 13485:2016 certificate from CERT INTERNATIONAL s.r. o. (International Certification Body). This significant stage in the development of our company was made possible by the high level of our standards and dedication on the part of all employees.

CERT INTERNATIONAL s.r. o., based on the results of a thorough audit conducted in accordance with certification procedures, confirms that the quality management system of medical devices developed and manufactured by ROSSA meets the requirements of international ISO standards.

Certificates from CERT INTERNATIONAL s. r. o., based on the International Accreditation Forum, are recognized almost all over the world, and give the opportunity to enter the markets of Europe, the USA, Canada, Japan, China, Germany, and the United Arab Emirates.

We will continue to strive to improve our processes and products to meet the expectations of our customers and partners, offering them innovative and high-quality solutions in the field of medicine.

ROSSA, a leading innovative developer of medical technologies from Uzbekistan, is proud to announce the successful registration of the ROSSAmed HIV-quant PCR kit and MagSorb Plasma isolation system in the Russian Federation. This recognition is of great importance for the Uzbek manufacturer and confirms the high level of quality and effectiveness of our products.

ROSSAmed HIV-quant and MagSorb Plasma will provide highly accurate and fast diagnostics, which will significantly increase the level of disease control and improve the quality of treatment for patients in Russia. This success highlights the important role that ROSSA products can play in the international medical arena.

The ROSSA Research and Production Complex is proud to announce that it has received a registration certificate for a new development – the “ROSSAmed MBT screen” PCR kit. This product is intended for the qualitative detection of DNA of mycobacteria from the Mycobacterium tuberculosis complex group (Mycobacterium tuberculosis, Mycobacterium bovis, Mycobacterium bovis BCG, Mycobacterium africanum, Mycobacterium microti) using the polymerase chain reaction (PCR) method with real-time detection of results.

The “ROSSAmed MBT screen” is a highly effective and accurate tool for diagnosing mycobacterial infections. The kit uses advanced PCR technology to detect the presence of mycobacteria in patient samples with high sensitivity and specificity.

Obtaining a registration certificate for the “ROSSAmed MBT screen” kit is an important step in the fight against tuberculosis and other mycobacterial infections. The new development will help medical institutions timely and accurately diagnose the disease, which will facilitate early treatment and reduce the spread of infection.

The kit contains the enzyme uracil-DNA glycosidase (UDG) and dUTP, which avoids contamination of the PCR mixture with products of previous PCR and obtaining false-positive results.

Possibility of using various types of amplifiers with detection of results in “real time” mode. For example: tablet type – “DTprime”, “DTlight”, “DT-96” (DNK-Technology LLC, Russia), or CFX96 (Bio-Rad Laboratories, USA), qTOWER 3 (Analytik Jena, Germany), Gentier 96E/ 96T/96R (Tianlong, China), rotary-type detecting amplifier, for example, Rotor-Gene 6000, Rotor-Gene Q (QIAGEN, Germany) and similar devices with the appropriate technical parameters.

On May 29-30, 2024, Director of the ROSSA scientific and production complex Tatyana Rudolfovna Hegay acted as a speaker at the Republican Conference of Geneticists of Kazakhstan in Almaty. Her report on the topic “From a research laboratory to the market: our experience in creating PCR diagnostics for orphan diseases” attracted great attention and aroused keen interest among the participants of the event.

During the presentation, Tatyana Rudolfovna shared the unique experience of ROSSA in the development of diagnostic tests for orphan diseases such as spinal muscular atrophy (SMA), primary immunodeficiency (PID) and HLA-B27. Special attention was paid to the use of advanced technologies, including real-time polymerase chain reaction (PCR-RV).

The director of the ROSSA scientific and production complex spoke about the process of transition from scientific research to the creation of finished products and their introduction to the market.

During the report, examples of successful implementation of diagnostic kits in clinical practice were presented, emphasizing their importance for early diagnosis and effective treatment of orphan diseases. Plans were also outlined to further expand the product range and enter international markets.

The conference participants highly appreciated Tatyana Hegay’s report for its informative and practical significance. The discussion raised a lot of questions and comments confirming the importance of the topic and the proposed solutions.

Tatyana Rudolfovna Hegay’s speech at the Republican Conference of Geneticists of Kazakhstan was an important event contributing to the strengthening of scientific ties and the exchange of experience in the field of genetic research and medical diagnostics. ROSSA’s success in developing PCR diagnostics for orphan diseases not only confirms its leadership in the industry, but also opens up new opportunities for the development of international cooperation.

The ROSSA company has achieved a significant breakthrough in the field of medical diagnostics, becoming the first in Uzbekistan to develop and register kits for the detection of a number of orphan diseases, including spinal muscular atrophy (SMA), for neonatal screening of newborns for SMA and primary immunodeficiencies (SMA/PID) and allele 27 of the human major histocompatibility complex locus B (HLA-B27) by real-time polymerase chain reaction (PCR).

Development value:

Spinal muscular atrophy (SMA): This is a rare genetic disorder that causes progressive muscle weakness and wasting. Thanks to a new set of diagnostic tests, doctors will be able to determine the presence of this disease much faster and more accurately, which will allow timely treatment to begin and improve the quality of life of patients.

Primary immunodeficiencies (PIDs): PIDs are characterized by disturbances in the immune system, making the patient more susceptible to infections. Early detection of these disorders using the new diagnostic kit will help in timely diagnosis and initiation of therapy, thereby preventing serious complications.

HLA-B27 allele: Associated with a number of autoimmune diseases such as ankylosing spondylitis. A kit to detect this genetic marker will allow doctors to diagnose these diseases earlier and more effectively treat them.

Technological features:
Kits from the ROSSA company use the real-time polymerase chain reaction (RT-PCR) method, which provides:

High sensitivity and specificity: Allows detection of even minimal amounts of genetic material.
Fast results: Diagnostics can be completed within a few hours.
Real-time monitoring: Provides highly accurate and reliable results.

Impact on healthcare
Screening and detection: New kits could be included in national newborn and adult screening programs, making it easier to detect genetic diseases at an early stage.
Personalized Medicine: Accurate and timely diagnoses will enable personalized treatment plans for patients, improving the efficiency of care.
Research: These kits will open up new opportunities for research work, which could ultimately lead to the development of new therapeutic methods.

The developments of the ROSSA company will not only have a positive impact on the healthcare of Uzbekistan, but will also strengthen the country’s position in the international arena in the field of medical diagnostics and biotechnology. This success is an important step forward in improving the health of millions and improving the level of health care services in the country.