The Daily Item, Sunbury, PA

March 29, 2013

Companies to exploit prenatal test loophole




The Yomiuri Shimbun

TOKYO — Companies plan to launch prenatal test services that could uncover chromosomal abnormalities in fetuses simply by examining the blood of pregnant women, a move seen as creating a loophole in the guidelines set by a medical association, The Yomiuri Shimbun has learned.

The prenatal test method is expected to start in the nation as early as next month as clinical research sanctioned under the guidelines of the Japan Society of Obstetrics and Gynecology (JSOG).

But only a limited number of medical institutions, which can conduct sufficient counseling to explain the genetic issues involved, will be allowed to use this new method.

Therefore, not all pregnant women who want to receive the prenatal diagnosis will be able to do so. The companies apparently intend to take advantage of the expected situation, according to sources.

Some experts see such a move as problematic because the test, which involves the issue of the fate of the child, is to be conducted commercially. It is likely to cause controversy and even invite calls for legal regulation, observers said.

Unlike the standard amniotic fluid test, in which a needle is inserted into a pregnant woman's abdomen, this prenatal diagnosis is simple and has little chance of causing a miscarriage.

According to a Tokyo company that has partnerships with overseas medical institutions in Guam and on the west coast of the United States, it expects a doctor to visit Japan to "see patients" in late April.

The blood of pregnant women will be taken at a clinic in Tokyo and sent to a testing company in the United States.

In addition to 25,000 yen ($266) for blood sampling, the prenatal testing will cost about 350,000 yen. The test results will be available in 10 days to two weeks, the company said.

A company spokesperson said, "We initially planned to ask pregnant women to travel overseas, but instead we made arrangements to take their blood samples in Japan."

The company has already received about 160 inquiries, the spokesperson said.

The company currently has no intention to conduct genetic counseling, with the spokesperson saying only, "We'll recommend that pregnant women speak to counselors."

Meanwhile, another company in Tokyo has promoted its prenatal diagnosis to medical institutions. In mid-March, the company sent out postcards advertising such a service to obstetric facilities nationwide.

In the postcards, the service was advertised as "the nation's lowest price and best quality." The testing fees begin from about 150,000 yen, excluding shipping charges.

The company said its test service could detect a different type of chromosomal disease that is not subject to prenatal test guidelines set by the JSOG.

Meanwhile, the company's website calls on medical institutions to provide genetic counseling and comply with guidelines of the Japanese Association of Medical Sciences, which stipulate that the views of the JSOG should be observed.

On March 22, the Japan Association of Obstetricians and Gynecologists, a separate organization of doctors concerned, sent a notice calling on its members not to use such services.

The JSOG also posted on its website a message asking for cooperation with its guidelines.