Roche Diagnostics, SCL Collaborate for Non-Invasive Prenatal Test

Roche Diagnostics Korea and Seoul Clinical Laboratories (SCL) have launched an analytical lab of the non-invasive prenatal test (NIPT), named Harmony, making it possible to conduct analysis based on domestic technology in earnest.

A researcher of the Seoul Clinical Laboratories analyzes the non-invasive prenatal screening (NIPT) test results at a lab installed in SCL.

The Harmony prenatal test analyzes the fetal deoxyribonucleic acid (DNA) in maternal blood and checks for triple X syndrome and a genetic disorder. Mothers can prepare for healthy childbirth based on the test results.

Harmony can screen for specific chromosome conditions in pregnancy as early as 10 weeks of gestation, with a low risk of complications, including preterm labor and stillbirth. More than 218,000 clinical cases in 59 peer-reviewed publications on the Harmony test showed high positive predictability and sensitivity for Down syndrome with low false-positive results.

The company's test method also showed a higher positive predictive value for Down syndrome and a lower false-positive rate than First Trimester Screening (FTS) in a clinical study on 15,841 mothers. The sensitivity of FTS was 79 percent, while the Harmony test was over 99 percent, according to Roche and SCL.

The collaboration has significance in that it has replaced the existing way to Ariosa cell-free DNA System (AcfS) that allows tests to be conducted directly in Korea, easing the limitations of sending out tests overseas and improving efficiency and accessibility, they said.

Before the collaboration, the sample extracted from the blood was sent to a laboratory in the U.S. for test analysis. Sending out the sample to the U.S. took about two weeks to receive the results from the day of departure. There were also difficulties in delivering the sample to the U.S. and deterioration of the stability of the sample.

“We value our partnership with SCL that allowed analysis on Harmony test results at a domestic lab amid the rising number of mothers past 35, who has a relatively higher risk,” Roche Diagnostics Korea General Manager Johnny Tse said. “We will continue to work with various organizations to foster a healthy society for both mothers and their children.”

SCL Diagnostic Laboratory Director Lee Mi-kyung said, “As the number of high-risk mothers in Korea continues to rise, Prenatal screening tests that can confirm the risk of triple X syndrome is significant.”

Lee added that SCL expects to help pregnant women and health providers make decisions based on evidence by providing faster and more accurate test results via cooperation with Roche Diagnostics Korea.