Patent for prenatal inspection technology... 3 major disease tests

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Patent for prenatal inspection technology... 3 major disease tests

운영자
Date 2021.01.26
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Patent right following NIPT product license... Enhancement of technological competitiveness

SeaSun Biomaterials (CEO Park Hee-kyung) announced on the 24th that it has completed the patent registration for the'method for detecting chromosomal abnormalities (prenatal malformation test technology)'.

Earlier, SeaSun Biomaterials launched a product that can test fetal malformations with the mother's blood with the approval of the Ministry of Food and Drug Safety for the first time in the world.

This patent is the original technology patent for the product, and it has completed an international application for PCT after domestic, and laid a foothold to inform the world of technology excellence and secure patent rights, including the United States, China, Europe, and Japan.

The core of this technology is to discover and detect a marker that distinguishes the fetal chromosome in the mother's blood from the mother's.

Through sequencing across the human genome, thousands of candidate markers per syndrome were selected, and the final selected markers obtained 98.9% sensitivity and 98.5% specificity through additional clinical trials, the company explained.

In particular, this technology is a technology that detects that the number of specific chromosomes is less or more than normal through real-time PCR. Using two PNA (artificial DNA) probes, one plays the role of erasing amplified genes, one Its strength is that it can clearly distinguish the number difference by increasing the subtle difference between normal and abnormal in a specific number of chromosomes by analyzing the remaining amount of amplified genes.

SeaSun Biomaterials first applied the technology to prenatal products. In 4 hours using the mother's amniotic fluid and blood, the results for Down syndrome, Edward syndrome, and Patau syndrome, which are the three major chromosomal abnormalities of the fetus, can be confirmed.

The prenatal test, which took 1-2 weeks, was shortened to 4 hours with this technology development. The prenatal testing market is growing by 5% every year worldwide, and the real-time PCR method has a bright prospect for overseas expansion thanks to the accuracy, speed, and economic feasibility of testing, Sisun Bio explained.

CEO Park Hee-kyung said, "As accuracy (sensitivity and specificity) is important, we have proved that the prenatal test is more than 98.5% with great care in clinical verification. After trying to overcome the limitations of the existing technology, "We have achieved great achievements, and we will continue to challenge ourselves in the future of developing molecular diagnostic technology."