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Noninvasive prenatal testing (NIPT), which can ascertain Down affection and added chromosomal altitude by blockage a sample of the mother’s blood, has been acclimated in Western countries for abounding years afterwards controversy.

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In China, NIPT, as it is known, was piloted in 2015, and official permission for its ytic use civic was accepted the afterward year. Now, though, the ysis is adverse a crisis of trust.

In July, an 8-month-old boy from Hunan arena was diagnosed with brainy disabilities and concrete deformities, admitting accepting been adjourned as low accident afterwards his mother had an NIPT ysis during pregnancy.

Although it was afterwards accepted that the ysis could not accept detected the boy’s problems, the case triggered accessible affair about the accurateness of NIPT afterwards dozens of women were appear to accept accustomed bearing to babies with Down affection afterwards accepting “false-negative” results.

Contributory Factors

According to the best contempo advice accessible — a address by the National Bloom and Family Planning Agency — the bulk of bearing defects civic was 5.6 percent in 2012, acceptation about 900,000 babies were built-in with defects.

Moreover, one in 10 families in China included a adolescent with a disability, according to the report.

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“In accession to factors such as ecology pollution, acknowledgment to radiation, or ailing lifestyles, abiogenetic problems are amid the best accepted causes of a ample cardinal of bearing defects such as Down syndrome, which retards concrete and brainy development,” said Duan Tao, administrator of the Shanghai Prenatal Analytic Center.

Duan said abiogenetic disorders can be buried and diagnosed prenatally via ultrasound examination, accepted claret tests that admeasurement the levels of two specific hormones and two proteins in the mother’s claret with an accurateness bulk of about 60 to 70 percent, and NIPT, which has an accurateness bulk of 99.3 to 99.5 percent.

NIPT detects chromosomal disorders by allegory a minute bulk of placental DNA in the mother’s blood, according to Zhou Daixing, CEO of Berry Genomics, one of China’s bigger next-generation sequencing technology companies.

In the accomplished seven years, the aggregation has provided NIPT casework to about 2.8 actor women. It claims apprehension acuteness of 99.5 percent, based on ytic follow-ups of added than 1 actor samples.

Zhou said NIPT covers three above chromosomal disorders: Down syndrome; Trisomy 13 and Trisomy 18 (which account astringent bearing defects and bassinet development); and irregularities in the cardinal of sex chromosomes, which can advance to altitude such as Turner or Klinefelter syndromes, which aftereffect from missing or bifold sex chromosomes.

“The bulk of fetal DNA in the claret sample influences the accurateness of the test. Also, back the DNA actuality activated comes from the placenta and not anon from the fetus, there is a very, actual baby achievability that the DNA we ascertain is not that of the fetus, which would advance to an inaccurate result,” he said.

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According to Zhou, the mother’s accepted bloom can additionally access the accurateness of the test; for example, if she is overweight, has cancer, autoimmune ache or has had an agency transplant. In addition, the ysis is not recommended for women accustomed added than one fetus.

Greater Provision

To abate the bulk of bearing defects, the National Development and Reform Commission’s 13th Five-Year Plan (2016-2020) emphasizes the accent of convalescent medical casework afore and during pregnancy. The agency has set goals of adopting the bulk spent on testing to 800 actor or 1 billion yuan ($116.5 actor to $145.7 million) a year by 2020 and accouterment gene tests for bisected of the absolute bairn population.

“Lots of parents accept actual aerial expectations of NIPT. Best bodies focus on its assurance and aerial accurateness rate, but they apperceive little about the technology itself and are blind of the abeyant for inaccurate results,” Duan said.

Reports advance that abounding women were accustomed the all-clear by NIPT but afterwards gave bearing to accouchement with concrete or brainy disabilities because the ysis was performed by a physician who either did not acquaint the parents of a accessible apocryphal aftereffect or bootless to conduct added tests, alike afterwards seeing ultrasound letters that adumbrated abeyant problems.

“Doctors comedy a acute role in allegorical mothers and authoritative the accommodation to conduct added tests, alike if the NIPT aftereffect is negative,” said Zhu Haiyan, administrator of the Prenatal Analytic Centermost at the PLA Navy Accepted Hospital in Beijing.

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Practical Differences

NIPT has been acclimated in the United States back 2011. In March 2016, the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine appear two convenance guideline bulletins to yze the purposes of and differences amid prenatal abiogenetic screening and prenatal abiogenetic ytic testing.

Because screening tests acknowledgment both false-positive and false-negative results, they charge be accepted via ytic testing for chromosomal disorders, such as amniocentesis (tests of the aqueous surrounding the fetus in the uterus) and sampling of chorionic beard (minute argosy that advice anatomy the bound amid affectionate and fetal claret supplies).

However, ytic tests are unpopular, according to Zhu. “Amniocentesis is invasive, and abounding mothers anguish about the accessible accident it could activate a miscarriage. In practice, the bulk is usually beneath than 1 percent, and an accomplished doctor could abate it to beneath than 0.1 percent,” she said.

“The botheration is the poor training accustomed to medical agents in some clinics, abnormally in third-or fourth-tier cities. Some doctors abode too abundant assurance in gene tests and don’t accommodate mothers with the all-important advice about the procedure.”

In the US, ACOG requires an obstetrician or added healthcare professional, such as a abiogenetic counselor, to altercate the after-effects of screening tests with mothers and advice them adjudge what to do next.

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In 2016, the NHFPC — now aished by the National Bloom Agency — appear a guideline advertence that women in China advancing to abide a prenatal DNA ysis charge be fabricated acquainted of the achievability of apocryphal results, and appropriate them to assurance an a consent. The guideline additionally emphasized that screening should not be admired as foolproof.

“However, abounding bodies don’t apprehend the a accord anxiously abundant or are clumsy to accept the abeyant for apocryphal after-effects afterwards the advice of a medical professional,” Zhu said.

“In China, we accept no abiogenetic counselors, and obstetricians in ample hospitals see about 30 patients in a half-day session, so they don’t accept time to accommodate alone consultations, which agency some patients accept the facts bigger than others.”

The PLA Navy Accepted Hospital’s prenatal centermost screens about 1,000 NIPT cases a year. Zhu said abounding patients who appear accept already had the ysis at baby clinics in third-or fourth-tier cities but charge a echo because some clinics apply capricious gene testing companies that don’t accord patients a abundant address on paper, but artlessly accelerate the aftereffect via argument message.

Cost Is Crucial

Yu Jun, above agent arch of the Beijing Institute of Genomics at the Chinese Academy of Sciences, said bulk is a acute agency to accepting authentic results.

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“NIPT technology has been accurate safe and useful. Best ysis providers in China use next-generation sequencing platforms and reagents fabricated by companies overseas. In added words, the accuracy, bulk and ability of NIPT is consistently codicillary on the affection of the materials,” Yu said.

From 2007 to 2013, the bazaar bulk of all-around gene casework soared from $8 actor to $4.5 billion, according to a address by BCC Research, a technology bazaar researcher. The bulk is predicted to ability $11.7 billion by the end of the year.

In the accomplished decade, the boilerplate bulk of a gene ysis has collapsed badly as a aftereffect of the acceptance of the technology and the rapidly growing market, according to Yu. An NIPT account costs about 2,500 yuan —10 times added than a accepted claret ysis — but it is not covered by State medical insurance

“China is one of the world’s better gene testing markets. Last year, alone about 20 percent of the country’s 20 actor abundant women had NIPT, abrogation abundant abeyant for approaching growth,” Yu said.

“At the aforementioned time, abounding baby companies accept approved to cool profits by binding costs and administering tests on samples that didn’t accommodated standards or by abbreviation the bulk of DNA actuality tested.”

He believes gene technology has prompted cogent improvements in the screening for abiogenetic diseases, blight ysis and biologic ambition discovery.

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“However, advantageous bazaar advance should be affirmed by able industry policies, austere laws and regulations, patient-friendly casework and acute accessible awareness. Those factors would advice gene testing to accommodate a above addition to people’s health,” he said.

(Source: China Daily)

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