硕果累累的市场：贝瑞和康开拓中国产前检测新时代

中国每年有1700万新生儿出生。但在2010年，全国仅能提供15万份的羊水穿刺产前诊断。对于中国这个世界上人口最多并且实施独生子女生育政策的国家，这个数字可以说是非常得低。

这意味着对于新一代产前检测，中国是一个时机成熟的市场。

美国塔夫茨大学医学中心母婴研究所的执行董事Diana Bianchi说：“无创DNA产前检测是新一代测序技术在目前临床上最广泛的应用。”这确实是一个很热门的领域。去年年底，Natera将服务范围从亲子鉴定、流产检测扩展到了无创DNA产前检测；上个月Illumina也声称计划要收购Verinata Health。

而现在，由周代星创办的贝瑞和康正致力于开拓中国的无创DNA产前检测市场。

作为贝瑞和康CEO、创始人之一，周代星透露：“经过十年的不懈努力，中国的产前筛查率在2008年达到了约15%，去年则达到了约20%。“

贝瑞和康则希望进一步提高产前筛查率。其公司创立于2010年，总部设在北京，并在2011年10月，成功完成了来自联想投资有限公司（现为君联资本）的首轮融资。联想投资有限公司是联想控股旗下（联想控股还拥有联想集团）设立在北京的专业从事风险投资业务的子公司。

贝瑞和康现已拥有300多名员工，已在国内20多个省市自治区与300多家医院建立了合作关系。

个人经历

贝瑞和康的创立与周代星自己的经历不无关系。2007年，他和妻子在期待第二个孩子出生的时候，曾亲身经历了怀孕所带来的种种焦虑。周代星感慨：“大多数父母都可能会经历那样的焦虑。”但对于采用测序进行产前检测的方法，他要比大多数父母更了解。

周代星在中国完成的本科学业，在美国马里兰大学巴尔的摩分校医学中心获得了博士学位后，到霍华德·休斯医学研究所、杜克大学医学中心完成了博士后学习。

此后，新一代测序技术始终贯穿于他的职业生涯。他曾担任过美国生命技术公司（Life Technologies）市场发展部资深经理、Illumina亚太日本区测序市场销售总监、Lynx公司生物信息部门经理、康宁（Corning Inc.）生命科学项目经理。

2007年底至2008年初，周代星与香港中文大学的卢煜明教授以及弗吉尼亚州立联邦大学的高远讨论利用新一代测序技术对胎儿游离DNA进行产前检测的可能性。基于这一想法，高远的实验室对卢煜明教授提供的28例样本（包含14例T21和14例正常样本）进行了双盲检测，成功检测出全部T21样本，检出率为100%。

2009年，周代星回到美国试着说服Life Technologies开展无创DNA产前检测，但周代星表示：“没有说服成功，因为当时公司只是一心想获得一个在美国开展的癌症项目。”所以他回到中国，创立了贝瑞和康。

贝瑞和康的成果

贝瑞和康的贝比安TM无创DNA产前检测，其原理与同行公司的检测原理大同小异，即：从母体外周血中分离出胎儿游离DNA后对其进行检测。目前该检测可针对21三体综合征（T21）、18三体综合征（T18）、13三体综合征（T13）以及其他染色体非整倍体疾病进行检测。

周代星介绍说，该技术流程相当复杂，可分为四步：样本采集运输至检测中心、DNA提取和文库构建、测序及数据分析。

其中，测序是目前最标准化的环节。周代星强调说：“其它三个环节包括样本如何采集运输、样本如何处理和建库以及测序后数据如何分析，其中每个环节都有我们独到的优势。“

贝瑞和康已将样本的运输和处理环节流程化，并且发明了专利性算法。周代星强调：“我们采用独创的算法和软件来分析数据，不同于其他任何一家公司。”

贝瑞和康已相继与中南大学湘雅医院产前诊断中心、北京协和医院成功完成了两期大规模临床试验。

对于其中的二期临床试验，2012年5月完成，周代星介绍，我们原计划在北京收集2000例样本。但当试验完成时，收集到了2300例样本，并且95%以上的孕妇都拿到了检测结果（另外3.8%的样本测序失败，还有一些样本没有妊娠结局随访数据），其中大约有500例样本同时接受了侵入性的产前诊断。

与世界其它地方发展趋势一致，无创DNA产前检测在中国的应用人群会越来越多。周代星说：“中国妇产科领域的专家小组讨论了很多种临床应用模式，如果孕妇不愿意进行侵入性的产前诊断，我们可推荐她们进行无创DNA产前检测。”他认为该检测在不久的将来可作为初步筛查。

展望未来，周代星希望贝比安无创DNA产前检测可扩展到检测更多染色体异常。21号、18号、13号染色体的异常仅占全部染色体异常的30%。他强调说：“我们的目标是通过不断优化技术实现对更多染色体异常的检测，包括微缺失、微重复的检测。”

贝瑞和康认为测序技术极有价值。周代星总结：“它不是一项具有挑战性的检测技术，而更是一种诠释。我们将在新的一年里尽最大的努力更好地理解未知生物学。”

周代星的目光投向更远的未来：“让这些技术能够检测所有的遗传缺陷疾病，是我孜孜不倦的追求。”

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Fruitful Market: Berry Genomics Tackles Prenatal Testing in China

Seventeen million babies are born each year in China. Yet in 2010, the country only had the capacity to offer 150,000 amniocenteses a year. As the most populous country in the world with a well-established one child policy, that number is astonishingly low.

And it represents a ripe market for the next generation of prenatal testing.

The noninvasive prenatal testing space is the most extensive current clinical application of next-generation sequencing, says Diana Bianchi, Executive Director of the Mother Infant Research Institute at Tufts Medical Center. And it’s a busy one. Late last year, Natera expanded from paternity and miscarriage testing into NIPT. And Illumina announced plans to acquire Verinata Health last month.

Now Berry Genomics, co-founded by Daixing Zhou, is hoping to capitalize on the market in China.

“The [prenatal] screening rate, after 10 years of intensive effort, in 2008, was around 15%,” explains Zhou, CEO and founder of Berry Genomics. “Last year it was around 20%.”

Berry hopes to increase that percentage. The company is based in Beijing and was founded in 2010. In October 2011, the company completed the first round of financing from Legend Capital, a Beijing-based venture firm that is a part of Legend Holdings which also owns the Lenovo Group.

Berry now has more than 300 employees and collaborations with more than 300 hospitals in over 20 provinces, cities and autonomous regions in China so far.

Personal Insight

Berry Genomics was born out of Zhou’s own experience. When he and his wife were expecting their second child in 2007, they experienced firsthand the anxiety that can come with pregnancy. “Most parents may experience that kind of anxiety,” Zhou says. But Zhou knew more than most parents about the sequencing options.

Zhou did his undergraduate work in China before earning his Ph.D. at the University of Maryland Medical Center at Baltimore. He went on to postdoctoral training at the Howard Hughes Medical Institute at Duke University Medical Center.

From there, his career was decidedly NGS-focused. He served as the Leader of Market Development at Life Technologies Corp., the Head of Sequencing Sales at Illumina-Asia Pacific Japan, the Director of Bioinformatics at Lynx Therapeutics/ Solexa Inc, and the Project Manager at Corning Life Science.

In late 2007 and early 2008, Zhou teamed up with Drs. Dennis Lo of Chinese University of Hong Kong (CUHK) and Yuan Gao of Virginia Commonwealth University (VCU) and discussed the possibility of using next generation sequencing to do prenatal detection by exploring the circulating fetal DNA. Applying their concept, Gao’s lab did a double blind test on 28 samples selected and provided by Lo—14 with trisomy 21 and 14 normal samples. Gao was able to identify 100% of the trisomy samples.

In 2009, Zhou returned to the U.S. to try and convince Life Technologies to pursue noninvasive prenatal testing. “It was not very successful because Life was so focused on getting a cancer project going in the U.S.,” Zhou said. So he returned to China—and with the help of two Chinese friends with NGS experience—built Berry Genomics.

Berry’s Fruit

Berry Genomics’ noninvasive prenatal test— Bambni Test—works similarly to others in the space. Circulating fetal DNA is extracted from maternal plasma and tested for abnormalities. The Berry test is currently looking at trisomy 21, trisomy 18 and trisomy 13, and other chromosome aneuploidy diseases as well.

The process is quite complex, though, Zhou says. He describes a four step process: sample collection and transporting to the testing facility; DNA extraction and library construction; sequencing; and data analysis.

The DNA sequencing is now the most standard step, Zhou says. “The other three parts:  how you ship the sample, how you process and make it into a usable library, and then how you analyze the data...We think our technology has advantages in all three parts.”

Berry has streamlined the shipping and sample preparation processes and has developed proprietary analytics. “We have our own algorithm and software to do analysis; it’s quite different from anyone else in the world,” Zhou says.

Berry Genomics has completed two phases of clinical trials in cooperation with the Prenatal Diagnosis Center in Xiangya Hospital of Central South University and Peking Union Medical College Hospital.

In a study finished in May 2012, the goal was 2000 samples from pregnant patients in Beijing, Zhou says. When the study was completed, the team had 2300 samples and more than 95% of women got their results (3.8% samples failed sequencing, plus a few more samples failed the post-delivery follow-up). About 500 samples received invasive procedures in parallel.

In China, like in the rest of the world, the payor landscape is still developing. “There are a few models being debated by expert panels in China,” Zhou says. “We recommend that most pregnant women in China take the test if they don’t want to take the invasive test.” He believes the test is suitable for primary screening in the future.

Looking forward, Zhou hopes that noninvasive prenatal testing can be expanded to cover more chromosomal abnormalities. Defects on chromosomes 21, 18, and 13 only account for 30% of chromosomal defects. “Our goal is to improve our technology to be able to cover more and more anomalies including micro deletions and micro insertions,” Zhou says

Berry views the sequencing as a commodity. “It’s not the detection technology [that is most challenging], it’s the interpretation. We’re probably going to emphasize our efforts in the next year to better understanding the underlying biology,” he says.

Zhou’s goals are lofty: “My personal passion is to be able to make these technologies cover [detection of] almost all of the genetic defects.”

来源：贝瑞和康