[Economicmagazine=Dono Lee] Asia’s eyes are focused on the company Solgent. The Korean molecular diagnostics solution company has developed a ‘New Corona Virus Detection Kit' that has dramatically improved the accuracy of diagnosing the disease that caused over 1,000 deaths and over 40,000 confirmed infections (Corona 19).
According to Jay You, co-CEO of Solgent, the company was established as a bio-enterprise in 2000 and has been engaged in continuous innovation, research and development activities. It has a business model that provides bio-materials to the global industry as infrastructure.
■ Korea's first Ebola Diagnostic Kit to be certified in Europe, Love Call from China
Solgent provides services that interpret information on the sequence of nucleic acids of various studies, including the development and production of PCR-based molecular diagnosis kits that can diagnose hereditary and infectious diseases, the identification of rice varieties, and the differentiation of Korean beef and imported meat, as well as the production of enzymes and raw materials (research reagents) necessary for various studies including molecular diagnosis kits.
"In December 2014, Solgent received the first European Medical Device Certification(CE-IVD) for the Ebola Diagnostic Kit (DiaPlexQTM Ebola Virus Detection Kit-Zaire) in Korea and also completed the development of the Zika virus diagnostic kit in February 2016. We also released a research diagnostic kit in 2015 that allows us to analyze the MERS virus and other respiratory viruses simultaneously within two hours through a single DNA test.
CE certification is an integrated standard certification mark, which means that it meets all the requirements of the European Union’s Council guidelines regarding safety, health, environment and consumer protection. In other words, Europe recognized Solgents technological prowess. Currently Solgent supplies diagnostic kits to 27 countries.
As such, after the Corona 19 outbreak, Chinese partners directly asked Solgent to develop diagnostics kits.
“The test results of Chinese kits from local companies showed that the corona 19 virus was beyond their capability.”
According to Hong Kong media, Chinese health authorities urgently increased the approval and supply of corona diagnostic kits to prevent the spread of the Corona 19, but poor accuracy is causing new problems.
A housewife in her 50s was initially tested negative, but as her condition worsened, she was re-examined and tested positive. The diagnosis took at least three days as the patient's sample was sent from to Beijing for examination due to a lack of diagnostic kits in Wuhan until the 16th of last month. One patient even was tested negative for three times, before turning out to be infected after they had examined samples from inside his lungs.
Meanwhile, Solgents “New Corona Virus Infection Kit” is 99% accurate. In addition, the diagnosis can be made in 2 hours. Traditional methods usually take 1-2 days to diagnose.
"Solgent has a unique technology called ASP (Allely Specific PCR). This technology can selectively amplify specific gene locations. It's a unique amplification technique of a particular gene in the new corona gene. It's a combination of development experience, mass production technology and licensing experience that has resulted in producing dozens of different kits."
Solgents diagnostic method is QRT-PCR (Real Time Quantitative PCR). The RT-PCR detects the new corona virus in the suspected patients and amplifies the genes to determine whether they are infected. Usually, even small amounts of the virus in the human body can cause symptoms, therefore the goal is to greatly increase the amount and examine them quickly.
As the news are spreading, not only China but also Thailand, Vietnam, the Philippines and the Middle East are requesting Solgents diagnostic kit. Overseas sales alone are worth 5 Billion Won.
“Currently Vietnam is testing Solgents “New Coronavirus Infection Diagnostic Kit” at the National Central Inspection Office where it is likely to be registered as a national standard reagent.”
■ Dissemination of local hub hospitals after approval of the Centers for Disease Control and Prevention
Solgent is awaiting emergency use approval from the Korea Centers for Disease Control and Prevention for the “New Coronavirus Infection Diagnostic Kit”. Emergency use approval is a system that allows the use of unlicensed products in the event of a national emergency such as infectious diseases. If approved, Solgents Corona 19 diagnostic kit will be distributed to local hospitals.
It has yet to ship 3-billion-won worth of goods, of which the export contracts are completed and is now awaiting approval for emergency use.
“Solgent is committed to developing and producing the highest quality diagnostic kit. We will do our best to ensure that these efforts shine, and that we get a quick emergency permit approval.”
Co-CEO Jay You did not forget his pride in being at the forefront of bioinformatics analysis.
"Solgent is a leading company in the present and future of molecular diagnostics and will contribute to improving the health and quality of life for the people."