The Unitary Enterprise "Pilot Production of the Institute of Bioorganic Chemistry" offers consumers A set of ELISA-CA125 reagents for determining the concentration of tumor antigen CA125 in human serum under a manufacturing agreement and is looking for partners to conclude a distribution services agreement.

Tumor antigen CA125 (Cancer Antigen 125) is an important biomarker used for the diagnosis and treatment monitoring of ovarian cancer, as well as for assessing other pathological conditions. Reagent kits for determining CA125 concentrations in human serum are used in clinical laboratories for quantitative analysis by enzyme-linked immunosorbent assay (ELISA), chemiluminescence assay (CLAs), and other methods.

Major global manufacturers of CA125 reagent kits:

1. Roche Diagnostics (Switzerland)
- Features: Manufacturer of CA125 assay kits used on automated Cobas® analyzers. They are characterized by high accuracy and reproducibility.
2. Abbott Laboratories (USA)
- Features: The company offers CA125 assay kits compatible with the ARCHITECT® and Alinity® platforms. They offer high sensitivity and automated analysis.
3. Siemens Healthineers (Germany)
- Features: Manufacturer of chemiluminescent CA125 assay kits used on ADVIA Centaur® and Atellica® systems.
4. BioMerieux (France)
- Features: Manufacturer of CA125 assay kits used on automated VIDAS® systems. Suitable for medium and large laboratories.
5. Diasorin (Italy)
- Features: Manufacturer of CA125 assay kits used on LIAISON® systems. High sensitivity and automation.
6. Randox Laboratories (UK)
- Features: The company offers CA125 assay kits that can be used on various automated analyzers.

Other specialized companies from various countries also operate in the market for diagnostic kits for determining the concentration of tumor antigen CA125 in human serum.

The IFA-CA125 kit, manufactured by the Self-Supporting Pilot Production Facility of the Institute of Bioorganic Chemistry, is designed to determine the concentration of CA125 in human serum using enzyme-linked immunosorbent assay.

Information about the reagent kit and instructions for use are available on the Company's official website here. (in Russian)

The kit is intended for in vitro use only.

The CA125 tumor marker is a mucoglycoprotein with a molecular weight of approximately 200 kDa. CA125 is an oncofetal protein and is the most informative tumor marker associated with ovarian tumors.

The Unitary Enterprise "Pilot Production of the Institute of Bioorganic Chemistry of the National Academy of Sciences of Belarus" was founded in 1986 as a specialized facility for the production of radioimmunoassay kits for the diagnosis of various human diseases. Today, it is a modern biotechnology enterprise with highly qualified personnel and a state-of-the-art production and technical infrastructure, enabling it to carry out complex technological processes and produce high-quality products.

The Unitary Enterprise "Pilot Production of the Institute of Bioorganic Chemistry of the National Academy of Sciences of Belarus" produces SARS-CoV-2-IgM/IgG rapid tests for the rapid detection of IgM and IgG antibodies to the SARS-CoV-2 coronavirus, which causes COVID-19.

Radioimmunoassay kits are the main type of diagnostic products manufactured. They are designed to diagnose thyroid diseases, assess the reproductive system and endocrine-metabolic processes, and identify tumor markers. The kits are equipped with solid-phase immunosorbents based on monoclonal antibodies and stabilized, ready-to-use liquid forms of standards and radioactively labeled preparations. In terms of analytical parameters and performance characteristics, these kits match the best foreign analogues.

The company, in collaboration with the Institute of Bioorganic Chemistry of the National Academy of Sciences of Belarus, develops and manufactures enzyme immunoassay kits for hormonal (for determining thyroid, steroid, and pituitary hormones) and oncology profiles, as well as kits based on lanthanide immunofluorimetric analysis for prenatal and neonatal diagnostics.

The infectious disease-specific enzyme immunoassay kits manufactured by the company through industrial cooperation are intended for the diagnosis of syphilis, viral hepatitis B and C, TORCH infections, AIDS, and coronavirus.

Official website of the Enterprise "Pilot production of the Institute of Bioorganic Chemistry."

The Enterprise has implemented a quality management system for the production of in vitro diagnostic reagent kits. In 2012, the company's quality management system was certified for compliance with the requirements of STB ISO 9001-2009 (Certificate of Conformity STB No. BY/112 05 01.002 02704). In 2017, the company's quality management system was certified for compliance with the requirements of the international standard EN ISO 13485:2012 (Certificate No. 9124.IBCN).

Consumers interested in purchasing the ELISA-CA125 Reagent Kit for the determination of the CA125 tumor antigen concentration in human serum under a manufacturing agreement.

Partners interested in purchasing the ELISA-CA125 Reagent Kit for the determination of the CA125 tumor antigen concentration in human serum under a distribution services agreement.