Sunday, 15 December 2013

Chinese genomic sequencing company worries Japan with cheap prenatal testing

Japanese medical authorities are expressing concern over prenatal testing for chromosomal abnormalities now offered by a Chinese company because it does not require clients to undergo counseling, which could lead to unnecessary abortions.
The Chinese company, BGI, recently entered the market and is offering the service in Japan at less than half the cost charged at facilities sanctioned by the Japanese Association of Medical Sciences (JAMS).
Fumiki Hirahara, a doctor of obstetrics at Yokohama City University who is well-versed in prenatal care, expressed concern over BGI’s program, citing the lack of counseling.
“If testing becomes common among expectant mothers, and they lack the mechanism to properly assess the accuracy of the results, it could prove detrimental for them (and their babies),” he said.
Hirahara said Japanese medical personnel started doing prenatal testing in April as part of clinical research, with an eye on evaluating the benefits of genetic counseling.

Prenatal testing involves blood testing of pregnant women to determine whether their fetus has Down syndrome or other developmental diseases. Prior to BGI’s entry into the Japanese market, women here in their late 30s and those who tested positive during ultrasound examinations had no choice but to take the tests at recognized facilities.
Experts say if fertility and obstetrics clinics contract with BGI, it could undermine the guidelines set by the Japan Society of Obstetrics and Gynecology (JSOG). Those guidelines, though, are not binding.
To allay concerns over a possible rise in abortions following the test results, the guidelines call for medical institutions providing prenatal testing to give women counseling in advance so that experts can fully explain the pros and cons of the test. It also called for those facilities to have a pediatrician with sufficient knowledge of genetics on staff.
The experts are concerned that if prenatal testing becomes too easily accessible at facilities not equipped with proper counseling services, women may opt to abort before acquiring sufficient understanding of the strengths and weaknesses of the test or the disease.
The number of medical facilities in Japan offering prenatal testing that meet the conditions set by JAMS, which makes those determinations based on the JSOG guidelines, is limited to about 30.
A U.S. company currently conducts blood tests for some Japanese medical institutions, but those facilities are all recognized by JAMS.
BGI, which is one of the world’s largest providers of genome sequencing service, is now approaching Japanese obstetrics and fertility clinics who lack the qualified counselors and experts as suggested under the JSOG guidelines to land contracts.
BGI was established in 1999 in China and has about 700 researchers. It established an affiliate in Kobe in July and started pitching its service this month, faxing clinics across Japan.
Its website emphasizes low cost services and offers literature on its prenatal testing.
The company approached some clinics to offer to conduct the testing at half of its publicized price, according to some officials at clinics contacted by the company.
Prenatal testing typically costs about 200,000 yen ($1,940) in Japan.
According to the literature, BGI can determine whether a fetus has Down syndrome, and other developmental diseases such as trisomy 13 syndrome and trisomy 18 syndrome around 10 days after receiving a blood sample.
Women must be at least 10 weeks pregnant to undergo the tests.
Although JSOG guidelines do not cover prenatal testing for women who were impregnated through in vitro fertilization, BGI provides that service, too.
The BGI affiliate declined to comment for a request for an interview with The Asahi Shimbun, saying no person in charge was available.
Some experts say BGI has more than 150 diagnostic testing devices to conduct genome sequencing; a number comparable to Japan’s overall total.
BGI began its prenatal diagnosis services in China two years ago. About 220,000 women have received the service so far.
The company provides testing in Britain as well.
According to reports, about 3,500 women in Japan have taken the test since prenatal testing became available at the recognized facilities in April. Some fertility clinics say requests for prenatal testing are increasing because most of their clients are women in their late 30s.
About 10 percent of the total number of women who sought the testing changed their minds about going through with the test after receiving counseling.
Source: Asahi Shinbun

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