World's first successful commercialization of NIPT approved products

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World's first successful commercialization of NIPT approved products

운영자
Date 2021.01.26
Hit 6,903

Prenatal test for fetal malformations in 4 hours with maternal blood

The world's first diagnostic product to screen for the three major malformations of the fetus (Down's syndrome, Edward's syndrome, and Patau's syndrome) with maternal blood was developed by domestic engineers.

SeaSun Biomaterials uses a real-time PCR analysis method to detect malformed children due to chromosomal abnormalities in 4 hours, using the Patio NIPT Detection Kit in food. It announced on the 8th that it had been approved by the Ministry of Drug Safety.

In the meantime, NIPT tests have not been licensed, so the analysis company has provided services using gene panels that have been self-organized, and even this has been using NGS (next-generation sequencing) technology for more than 1 week for testing, and 2 weeks for testing requests from foreign countries. I had a problem that took me to.

In addition, due to the need to use the NGS platform of large overseas companies such as Illumina or Thermo Fisher, there is concern about an increase in inspection costs as they are forced to pay an additional $75 analysis royalty in proportion to the number of inspections.

An official at SeaSun Biomaterials said, "As it is a licensed product, it can provide safe and reliable results, and it is the fastest among the current tests, so even if you pass through a medical institution, you can receive the results within 2 to 3 days, so you are keen to see if the fetus is abnormal. It can greatly reduce the period of anxiety for the family and the family.”

Park Joong-shin, a professor of obstetrics and gynecology at Seoul National University Hospital, who was in charge of the licensed clinical trial said, "As a result of clinical evaluation of the accuracy of the SeaSun Biomaterials diagnostic kit in 1552 Korean mothers, the sensitivity and specificity were 98.9% and 98.5%, respectively, demonstrating clinical efficacy and safety "It's done," he said, "it will be possible to avoid the amniotic fluid test that follows pain and bleeding, so it will spread as a safe and painless test method for many mothers." Professor Park is preparing to publish a paper on the results of this clinical study in a famous journal.

CEO Park Hee-kyung said, "In January last year, we developed a kit that detects fetal malformations with amniotic fluid and proved high test accuracy, and in just one year, we launched a fetal prenatal test with the same accuracy with only maternal blood." It has proven that technology has taken a leap forward.”

In particular, he emphasized, "If you use the NGS analysis system of a global company, a lot of royalties and personal genetic information or big data are leaked abroad, and it is the big income of this localization that can be blocked."

The NIPT blood differential diagnosis kit received 1.5 billion won in government contributions for two years (2017-2018) through the project' Development of prenatal and postpartum genetic testing technology to detect chromosomal abnormality syndrome and febrile genetic disease' supported by the Ministry of Trade, Industry and Energy. Gaze Biomaterials was the supervising institution, and Professor Park Jung-shin's team at Seoul National University Hospital, and Korea Institute of Science and Technology Information contributed as a participating institution.