The diagnostic system is based on the real-time reverse transcription polymerase chain reaction (RT-PCR) method. The test kit targets three sites of the coronavirus RNA-the E gene, the RdRp gene and the N gene. The duration time is 120 minutes, diagnostic sensitivity is 95%, specificity is 100%.
Osang Healthcare received European certification for the product in February 2020. In March 2020, the Korean authorities approved the export of tests, and in mid-April 2020, the test system received authorization from the US FDA. The US has already purchased a batch of tests for a total of $3 million.
Osang Healthcare was founded in 1996 and specializes in the development of diagnostic devices: it produces test systems for immune and molecular diagnostics, devices for measuring blood sugar, hemoglobin and cholesterol levels.
According to SPARK-Interfax, Avivir LLC was registered in 2019 and is 100% owned by Himrar-Pharma LLC. The company's financial indicators are not disclosed. On its website, the supplier offers tests for antibodies to SARS-Cov-2 produced by the Chinese Innovita Biological Technology Co.
Earlier, Himrar announced a project to produce a domestic generic Favipiravir for the treatment of patients with coronavirus. The company will create a joint venture with the RDIF, which will promote the drug. The first batches can be delivered in April, in 2020 it is planned to produce 600 thousand packages of the drug.
Currently, 15 tests for SARS-Cov-2 have been registered in Russia: from state manufacturers, the holders of RU are subordinate institutions of Russian Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor), FMBA, the Ministry of Defense, from private companies – LLC "NPF "Litech", JSC "Vector-Best", LLC "DNA Technologies TS", the pharmaceutical company "Generium", a joint venture of LLC "Genetic Technologies" and the Japanese K. K. Mirai Genomics LLC "Evotek-Mirai Genomics" and other companies.
The article is published on Vademecum