Prenatal testing, the most popular in China, is banned, affecting current projects at providers—another lesson for laboratories in how quickly things change
Genetic testing has been halted in China. This unexpected decree was announced in February. Government officials cited challenges surrounding “ethics, privacy, and the protection of human heredity resources, in a message posted on the China Food and Drug Administration’s website.
Authorities named prenatal DNA tests in particular as an area of concern in genetic testing. This may surprise pathologists and clinical laboratory professionals, who have regularly read about the substantial investments major Chinese companies have made in the field of gene sequencing.
Complete Genomics Was Recently Acquired by BGI-Shenzhen
In fact, Dark Daily reported on February 21 that BGI-Shenzhen acquired Mountain View, California-based Complete Genomics last year for $117 million. This acquisition furthered its strategy to position itself as “the” global sequencing outsourcing provider. (See Dark Daily, “Illumina Asserts Its Claim of a $1,000 Whole Genome, But is Gene Sequencing Ready for Use by Clinical Pathology Laboratories?” February 21, 2014.)
BGI declined to comment in a story published by Forbes Magazine in March on the genetic test ban and on how the Chinese government’s action may affect BGI’s business goals.
Prenatal testing is the most popular genetic test in China, according to Forbes Magazine. The Forbes story quoted a Chinese securities analyst who estimated the market for genetic testing to be worth 50 billion yuan a year (or $8 billion U.S.), based on the number of anticipated births and a $480 testing fee.
China Changing Course after Decades of Genetic Testing
For more than 50 years, China has promoted the growth of genetic testing to prevent and address birth defects, reported Genetic Engineering & Biotechnology News (GEN). It published a story on these developments, noting that the new regulation reportedly bans genetic testing “including prenatal genetic testing, gene sequencing technology-related products, and cutting-edge products and technologies.”
The ban on genetic testing in China affects “all medical technology applications requiring detection equipment, medical diagnostic reagents, and related software, as well as other products used for disease prevention, diagnosis, care, treatment, monitoring, health status evaluation, and prediction of genetic diseases,” according to Google Translate.
Rule Banning Genetic Testing Caught Experts by Surprise
“There wasn’t any information released before the new regulation came out. Everybody got shocked. Everything has stopped. Everything involved in sequencing using machines that has not been approved has been stopped. No one has an idea when it’s going to be reopened,” stated Nanbert Zhong, M.D., an investigator with Peking University Medical Center of Medical Genetics, Shanghai Children’s Hospital, and head of the Developmental Genetics Laboratory at the New York State Institute for Basic Research in Developmental Disabilities, in the GEN article. Others speculated that Chinese officials are concerned about safety and costs.Jeremy Gruber, J.D. (pictured above), is President and Executive Director of the Council for Responsible Genetics. He told the reporter from Genetic Engineering News that the China FDA’s ban on genetic testing was simply regulators hitting the “pause button to ensure that the appropriate safeguards are in place, not to limit the progress of genetic testing [in China].” (Photo copyright TarrytownMeetings.com.)
Population Pressures Affecting Family Planning in China
China’s population is the largest in the world and among the fastest growing. The government in China adopted a one-child policy in September 1980 to slow population growth. That order was reportedly relaxed in November 2013. News stories have suggested that Chinese parents-to-be seek genetic tests to explore health, sex, and other traits. Now, genetic test providers may need to get special permission from the government to do these tests.
China’s FDA is not the only authority saying, “Not so fast,” when it comes to genetic testing services. Dark Daily readers may recall news about the U.S. Food and Drug Administration ordering 23andMe to remove its genetic tests from the market and cease advertising genetic testing last December. (See Dark Daily, “23andMe Socked with FDA Warning Letter and Class Action Lawsuit over company’s Genetic Testing Services,” December 11, 2013.)
The decision by government officials in China to suddenly ban all genetic testing represents an unexpected development on the path toward increased genetic testing. Like the FDA’s actions directed toward 23andMe, it shows that healthcare regulators in different countries are struggling for ways to appropriately regulate genetic testing. Pathologists and clinical laboratory professionals can take this as a sign of tougher government oversight of genetic testing in the years to come.
—By Donna Marie Pocius