Preeclampsia is one of the top three risks of pregnancy with premature obstetric labor and delivery-related hemorrhage. Roche Diagnostics Korea has drawn attention with “soluble fms-like tyrosine kinase-1 (sFlt-1)/placental growth factor (PlGF)” test, which has drastically raised accuracy in diagnosing preeclampsia.
According to Statistics Korea, one out of four newborns (26.4 percent) in Korea was delivered by mothers aged 35 or more last year. The rising age of first-time mothers leads to an increase in preeclampsia incidence. According to the Health Insurance Review & Assessment Service, pregnant women aged 35 or more, who received medical treatment due to preeclampsia, rose by 33.4 percent in 2014 from 2010.
Toxemia of pregnancy has various symptoms, making it difficult to predict and manage the disease with the existing tests of blood pressure and proteinuria. The best way to treat preeclampsia is delivery, but it takes the risk of premature labor. However, “sFlt-1/PlGF” test can diagnose the disease with 99 percent accuracy and predict its occurrence with 38.4 percent accuracy.
Such new diagnostics method quickly received insurance benefits in September, in just about a year after obtaining approval as “a new medical technology.” Korea Biomedical Review met with Choi Su-hee, Roche Diagnostics Korea’s product manager and the chief of its clinical value marketing team, to learn the details about “sFlt-1/PlGF” testing.
Question: Can you explain what “sFlt-1/PlGF” is?
|Choi Su-hee, Roche Diagnostics Korea’s product manager, speaks about “sFlt-1/PlGF,” known as blood testing for preeclampsia, in an interview with Korea Biomedical Review.|
Answer: To date, preeclampsia has been diagnosed based on two markers – proteinuria and high blood pressure. But the two symptoms are frequently observed in pregnant women, even when they do not have preeclampsia. Also, a pregnant woman who does not show the two signs simultaneously can have preeclampsia. In short, the existing tests had a low level of singularity and sensitivity.
So, even after physicians diagnose preeclampsia, they found it difficult to decide when to hospitalize patients or how frequently they should visit the hospital. With anxiety, pregnant women also had to take more financial burden due to frequent medical visits. Our sFlt-1/PlGF testing is a simple blood test, done in between 20 and 34 weeks of pregnancy, which alleviates the burden and anxiety, both for doctors and expectant mothers.
Q: How does sFlt-1/PlGF diagnose preeclampsia?
A: We created the test based on the idea that preeclampsia develops when there is a blood supply disorder after the implantation. In early- and mid-stage pregnancy, blood vessel creation inhibitor sFlt-1 is maintained at low levels while blood vessel creation accelerator PlGF shoots up. In the end-stage of pregnancy, PlGF goes down while sFlt-1 goes up. However, pregnant women diagnosed with preeclampsia have low levels of PlGF and high levels of sFlt-1. By measuring the two, we can diagnose preeclampsia.
Q: Who should receive the test?
A: Among women in between 20 and 34 weeks of pregnancy with suspected preeclampsia, those who meet the following one or more conditions should have themselves checked; those who had experienced preeclampsia or has a family history; those who have high blood pressure with readings higher than 140/90mmHg; those who had a high level of protein in their urine (with dipstick results showing 1+ or higher measurement or showing higher than 300mg/L in a 24-hour proteinuria test); those with multiple pregnancy; and those with fetal growth retardation who had an increase in hepatic enzymes in a liver function test.
Q: Your test method has high accuracy in diagnosing preeclampsia, but prediction rate is relatively low, isn’t it?
A: Although diagnosis rate is low, we should pay attention to the fact that the exclusion rate is high. If a high-risk pregnant mother shows symptoms to suspect preeclampsia, both the physician and the mother worry a lot about it. But they can relax at least for four weeks of sFlt-1/PlGf testing to figure out whether she has preeclampsia or not.
Q: What is the merit of sFlt-1/PlGF, besides the accuracy?
A: Physicians can check the results of sFlt-1/PlGF concentration so that they can easily diagnose preeclampsia. Patients confirmed to be not having preeclampsia do not have to go through unnecessary examinations, and they can be relieved from anxiety. This test is automated in every process, so there is no probable deviation among tests. If you are equipped with the testing machine, you can check the result within 18 minutes. Thanks to these merits, the U.K.’s National Institute for Health and Care Excellence (NICE) recommends sFlt-1/PlGF testing in their diagnosis guidelines. In Germany, the testing is recommended during the 20th week of pregnancy.
Q: How much should a patient pay for the test?
A: They can pay only 50 percent of the total cost of the test. When it was designated as a new medical technology, a patient had to pay 130,000 won to 150,000 won. However, as the government allowed the test to be covered by selective health insurance in September this year, a patient can pay 35,000 won to 40,000 won now. Korea’s approval for insurance reimbursement of sFlt-1/PlGF was the first in Asia, and the third in the world.
Since the test received the insurance benefit, hospitals are increasingly adopting the test. Our company made a contract with major local medical examination companies so that small clinics without sFlt-1/PlGF examination equipment can also easily conduct sFlt-1/PlGF tests. Now, the test is available everywhere in Korea.
Q: What is your plan, regarding sFlt-1/PlGF test?
A: According to our survey of 500 pregnant women, 40 percent of them regarded preeclampsia symptoms as general symptoms of pregnancy. We will raise the currently low awareness about preeclampsia. As sFlt-1/PlGF is new, the company will also run various programs to assure physicians and pregnant women to trust the test.
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