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BT-IT-NT CONVERGENCE TECHNOLOGY

Sugentech Inc. develops in-vitro diagnostic systems and products
based on BT-IT-NT Convergence Technology

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Smart features

BT-IT-NT CONVERGENCE TECHNOLOGY

Sugentech Inc. develops in-vitro diagnostic systems and products
based on BT-IT-NT Convergence Technology

view more
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South Korean IVD Company, SUGENTECH’s, COVID-19 IgM-IgG Rapid Test Listed on FDA

SEOUL, South Korea - April 8, 2020 - ( Newswire.com )  ‘SGTi-flex COVID-19 IgM&IgG’ is an immunochromatographic test kit for the qualitative determination of COVID-19’s IgM and IgG antibodies in whole blood (finger prick or venous), serum or plasma. The kits are accurate and easy to use, and results can be observed with the naked eye within 5-10 minutes. It has already received CE-IVD certification and is approved for exports from South Korean MFDS, and it showed 94.4% accuracy in clinical trials, which has been done with 250 samples in Daegu, South Korea.  ‘SGTi-flex COVID-19 IgM&IgG’ is already being distributed in many countries in the EU and Asia, and in recent field tests in many renowned labs, including LMZ Dr. Risch Group in Switzerland, ‘SGTi-flex COVID-19 IgM&IgG’ has shown prominent performance in the neutralization test and been recognized even significant detection of early patient with IgM. SUGENTECH is planning to go further to seek EUA from the U.S. FDA.  Limits of RT-PCT for COVID-19  The real-time PCT (RT-PCR) test seeking the COVID-19 specific virus suffers from some inherent drawbacks such as 1) limitation of good sample patients (recent study tells that the upper respiratory sample has 30% sensitivity), 2) the need for specially trained technicians and equipped certified labs to run the test, and 3) high level of need in resources, e.g. cost and time.     Moreover, it has been reported that many COVID-19 virus-shedding patients are asymptomatic or have very few symptoms, and the period of virus shedding starts very early and stays so long, even when the virus titer is quite low.     ‘SGTi-flex COVID-19 IgM&IgG’ is a serological (blood) rapid test.     ‘SGTi-flex COVID-19 IgM&IgG’ detects the presence of COVID-19 specific lgM & lgG antibodies, which are specific proteins made within days after infection, even in patients that don’t have symptoms. The antibodies detected by this test indicate that a person had an immune response to COVID-19, whether symptoms developed from infection or the infection was asymptomatic. Antibody test results are important in detecting infections with few or no symptoms. It covers the entire course of infection and improves the overall diagnosis of COVID-19 in acute phases of illness.     It is very important to diagnose COVID-19 to defend against the expansion of COVID-19. ‘SGTi-flex COVID-19 IgM/IgG’ helps communities to identify infection and isolate people without symptoms but suspected to be infected by COVID-19.     ※ related story :  https://apnews.com/5c722e99584e488b0f07427df4249a0d 

March 28, 2020 Philippines' Senate Manny Pacquiao tested COVID-19 with SUGENTECH's rapid test kit

 Pacquiao negative for COVID-19 after being tested twice   MANILA, Philippines — Sen. Manny Pacquiao said he has tested negative for the coronavirus disease 2019 (COVID-19) twice but added that once he experiences symptoms of the deadly virus he will undergo swab testing with the Research Institute for Tropical Medicine (RITM). “Twice na,” said Pacquiao in a brief phone interview on Saturday from his quarantined home in Dasmarinas Village in Makati. Pacquiao said the members of his family also took the tests using a “rapid-testing kit,” which was provided him by a friend from South Korea. “Negative. We’re in good health. No symptoms,” said Pacquiao, who did not say if members of his staff or his household took the test. The boxing icon vouched for the integrity of the testing kit that was used, saying it’s the same one being used in South Korea. “Maganda ‘yan,” said Pacquiao, who added that he took the second test last Friday and the first one a few days earlier. Pacquiao assured everybody, including his fellow residents at Dasmarinas Village, that he is safe from COVID-19. “Negative,” he said after he received an official letter from Barangay Dasmarinas considering him a “person under monitoring” (PUM) because he was seen partying with fellow Sen. Koko Pimentel, who was found positive for COVID-19. Two other senators, Migz Zubiri and Sonny Angara, have also tested positive for the virus. “For your own family and household’s safety, please have yourself self-quarantined, stay home. No one, including any of your household, can come out,” the letter said. Pacquiao said has diligently observed self-quarantine even before he received the letter, and urged his countrymen to do the same. “Just obey the orders of the government,” he said, adding that he fears that the situation is far from over. “Not only in our country but the whole world. Buong mundo. Parang peak pa lang,” he said. Pacquiao said he has not left his home since March 23 when the Senate held a special session.  “After that, nag-home quarantine na ako. Hindi na po ako lumabas ng aming bahay,” he said. Pacquiao said he is saddened by the fact that three of his fellow senators have tested positive for COVID-19, and that he could not be present during the release of the 57,6000 test kits donated by Chinese tycoon Jack Ma through his Manny Pacquiao Foundation the other day. “Nag-stay na lang ako sa bahay,” he said.  ※ related story : https://www.philstar.com/sports/2020/03/28/2004065/pacquiao-negative-covid-19-after-being-tested-twice  

SUGENTECH launches_10 Minutes blood test for COVID-19

The 10 Minutes blood test for COVID-19,  even for asymptomatic patients with a long incubation period   SEOUL, Mar. 06, 2020 - Sugentech has successfully developed rapid test kits for the COVID-19, detecting IgM, IgG and IgM/IgG antibody.     SGTi-flex COVID-19 IgM&IgG is a gold nanoparticle-based immunochromatographic test kit for qualitative determination of COVID-19’s IgM and IgG antibodies in human whole blood (finger prick or venous), serum or plasma. The kits are accurate and easy to use and results can be observed with the naked eye within 10 minutes. It has already been approved for clinical trials in South Korea.   The test detects the presence of antibodies, which are specific proteins made in response to infections. Antibodies can be found in the blood of those who are tested after infection. The antibodies detected by this test indicate that a person had an immune response to COVID-19, whether symptoms developed from infection or the infection was asymptomatic. Antibody test results are important in detecting infections with few or no symptoms.     Limits of RT-PCT, the gold-standard for COVID-19   Until now, A 'real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test has been considered the gold-standard for diagnosing infection of COVID-19. However, performing this test requires taking throat and nasal swabs from patients - a rather unpleasant process for patients and health care workers alike - and testing those samples for reactions that indicate they contain the genetic material of COVID-19.  Also, it involves multiple components, which are notoriously complex, it has to be run by specially trained technicians, using specialized equipments.   Even the smallest DNA contamination can disrupt results from RT-PCR tests although this is in reference to this general type of test, the diagnostic for COVID-19 in particular.  Moreover, the virus may not be detectable in early stage when the virus titer is low during a long incubation period. This can lead to a false-negative result or misdiagnosis and also are unable to meet the global needs of rapid testing.   The SGTi-flex COVID-19 IgM/IgG Rapid Test - is a blood test.    Immunoglobulin antibodies, lgM & lgG, appear after the COVID-19 infection and initiate an immune response. IgM antibody is an indicator of current infection and IgG antibody is an important indicator of recent and past infection. The SGTi-flex COVID-19 IgM/IgG test purports to be able to detect COVID-19 specific lgM & lgG antibodies within 10 minutes, using either an IV blood sample or a droplet retrieved via finger-prick - even in patients that don't have symptoms. It covers the entire course of infection and improves the overall diagnosis of COVID-19 in acute phases of illness. As there is no medicine or vaccine, the best way to combat this infection is isolation. A lot of people don’t have symptoms. Because of that, quick diagnostics are very important. SGTi-flex COVID-19 enables to help for community to identify infection and isolate people without symptoms but suspected COVID-19.  

World's first blood-based TB diagnostic kit launched in China

Sugentech has announced that it has begun clinical trials of its tuberculosis diagnostic kit in China. Tuberculosis, one of the three major infectious diseases managed by the World Health Organization (WHO), has only been diagnosed using sputum, making accurate and rapid diagnosis difficult. Sugentech has developed the world's first kit for the diagnosis of tuberculosis in blood and has confirmed its excellent clinical performance in the domestic clinical trial earlier this year and has applied for permission to the Korea Food Research Laboratories. The company has been promoting a business alliance with global clinical trials to enter the global diagnostic market of 3 trillion won annually and has recently started clinical trials with one of the three largest TB drug producing countries in the world. Clinical trial results will be available within a few months, and license-out agreements will be concluded with Chinese pharmaceutical companies based on clinical trial results. The company is also negotiating clinical trials and licensing procedures with two Southeast Asian health authorities and is also targeting WHO certification and supply through multinational clinical trials. In fact, the US company Sepheid developed a small molecule diagnostic device using sputum and supplied 660,000 test cases to WHO only in 2018, and sold 6 billion won a year and acquired 5 trillion won in multinational diagnostic company Danaher. A company representative said, "Generally, diagnostic products are in the form of distributor contracts, but the blood-based TB diagnostic kit is worthwhile as an innovative first-in-class product and is negotiating license-out contracts. "We are pursuing a business alliance with a number of global diagnostics companies due to high market demand." Sugentech is a biotechnology company specializing in bio diagnosis. It is based on three diagnostic platforms including multiple immunoblot for general hospitals, on-site diagnosis for small and medium hospital (POCT), and personal personal care. It provides allergy, autoimmune disease, Alzheimer's disease, influenza, tuberculosis, periodontal disease, It is a company that has first-in-class diagnosis technology such as early diagnosis of Alzheimer's disease, blood-based tuberculosis diagnosis, periodontal disease diagnosis, and chronic disease diagnosis.

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