News of the «Medgamal» Branch

The Medgamal Branch of the FSBI National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya of the Russian Ministry of Health starts commercial production and sale of a medical device "A set of reagents for the differential determination of IgM antibodies to Zika, dengue, West Nile, Chikungunya viruses in human serum by the method of enzyme immunoassay "ELISA-IgM-Zika, dengue, ZN, Chik". The kit is intended for the simultaneous performance of 24 analyzes of blood serum of patients with suspected infections on a demountable 96-well plate.

According to the decision of Roszdravnadzor No. 10-20932/20 dated April 16, 2020, the registration of a medical device "A set of reagents for determining the level of anti-alfastaphylolysin in serum blood products of humans and animals "Staphylococcal diagnostic toxin" according to TU 9383-001-01894956-2009 was canceled.
Based on this decision, the Staphylococcal Diagnostic Toxin Kit for determining the level of antialfastaphylolysin in serum blood products of humans and animals "Staphylococcal diagnostic toxin" will be produced and sold as a diagnostic reagent. The set is a reusable product.

According to the requirements of the Federal Law dated April 12, 2010 No. 61-FZ "On the Circulation of Medicines" as amended on August 2, 2019, the subdivisions of the FSBI National Research Center for Epidemiology and Microbiology named after the honorary academician N. F. Gamaleya of the Russian Ministry of Health have tested and started using a mandatory system of labeling and traceability of manufactured drugs.

Production of the medical product - The set of reagents "Fluorescent Tularemia Dry Diagnostic Immunoglobulins" is organized at the "Medgamal" branch of the FSBI N. F. Gamaleya National Research Center of Epidemiology and Microbiology under the Health Ministry of Russia.

The set is aimed for high-quality express indication of the bacteria - pathogens (causative agents) of Tularemia using the direct immunofluorescent method in smears from bacterial cultures (pure and mixed) and in pathological human biomaterial.

The set is produced according to TU 21.20.21-023-01894956-2018 based on the Registration Certificate, issued by Roszdravnadzor (Federal Supervisory Agency for Health Care of Russia) on August 23, 2018 No. FSR 2010/08923.

Production of the medical product - The set of reagents "Fluorescent Brucellous Dry Diagnostic Immunoglobulins" is organized at the "Medgamal" branch of the FSBI N. F. Gamaleya National Research Center of Epidemiology and Microbiology under the Health Ministry of Russia.

The set is aimed for high-quality express indication of the bacteria - pathogens (causative agents) of brucellosis using the direct immunofluorescent method in fixed neutralized smears from bacterial cultures (pure and mixed), including those separated from the human pathological biomaterial.

The set is produced according to TU 21.20.21-021-01894956-2019 based on the Registration Certificate, issued by Roszdravnadzor (Federal Supervisory Agency for Health Care of Russia) on August 23, 2018 No. FSR 2010/08925.

In 2017, a multicenter, double-blinded, randomized, placebo-controlled phase II clinical trial was successfully completed to study the safety, efficacy and selection of optimal dosages with a course of treatment for a new drug for the treatment of chronic wounds and ulcers "LPS, gel for external use."
The drug is intended for the treatment of diabetic wounds, including diabetic foot syndrome, as well as trophic wounds resulting from circulatory disorders. It is used in the phase of epithelialization and granulation, promotes the healing of such wounds in a shorter time.

In the course of phase II clinical trials, the drug showed high efficacy and demonstrated the safety of use in a hospital and outpatient use.

At present, under the leadership of Leading Researcher, Ph.D. A.V. Kostarny a protocol for a phase III clinical trial is being developed on an expanded sample of patients.